Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Benefit Subjects With Hepatitis C Liver Disease

October 10, 2013 updated by: GlaxoSmithKline

Randomised, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus (HCV) Infection Who Are Otherwise Eligible to Initiate Antiviral Therapy (Peginterferon Alfa-2b Plus Ribavirin)

The purpose of this study is to assess the ability of eltrombopag to maintain a platelet count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral therapy dose reductions and to avoid permanent discontinuation of antiviral therapy. The clinical benefit of eltrombopag will be measured by the proportion of subjects who are able to achieve a Sustained Virological Response (SVR).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
759

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2606
        • GSK Investigational Site
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • GSK Investigational Site
      • Randwick, New South Wales, Australia, 2031
        • GSK Investigational Site
    • Queensland
      • Cairns, Queensland, Australia, 4870
        • GSK Investigational Site
      • Herston, Queensland, Australia, 4029
        • GSK Investigational Site
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • GSK Investigational Site
      • Fitzroy, Victoria, Australia, 3065
        • GSK Investigational Site
      • Parkville, Victoria, Australia, 3050
        • GSK Investigational Site
      • Prahran, Victoria, Australia, 3181
        • GSK Investigational Site
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • GSK Investigational Site
  • Belgium
      • Bruxelles, Belgium, 1200
        • GSK Investigational Site
      • Edegem, Belgium, 2650
        • GSK Investigational Site
      • Gent, Belgium, 9000
        • GSK Investigational Site
      • Leuven, Belgium, 3000
        • GSK Investigational Site
  • Brazil
      • São Paulo, Brazil, 04023900
        • GSK Investigational Site
    • São Paulo
      • Campinas, São Paulo, Brazil, 13083-888
        • GSK Investigational Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2C8
        • GSK Investigational Site
    • British Columbia
      • Victoria, British Columbia, Canada, V8V 3P9
        • GSK Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
        • GSK Investigational Site
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • GSK Investigational Site
      • Hamilton, Ontario, Canada, L8N 4A6
        • GSK Investigational Site
      • Hamilton, Ontario, Canada, L8L 2X2
        • GSK Investigational Site
      • London, Ontario, Canada, N6A 5A5
        • GSK Investigational Site
      • Ottawa, Ontario, Canada, K1H 8L6
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M5T 2S8
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M5G 1X5
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M5G 2C4
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M6H 3M1
        • GSK Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • GSK Investigational Site
      • Montreal, Quebec, Canada, H2X 3J4
        • GSK Investigational Site
  • Czech Republic
      • Hradec Kralove, Czech Republic, 500 12
        • GSK Investigational Site
      • Olomouc, Czech Republic, 775 20
        • GSK Investigational Site
      • Praha 6, Czech Republic, 169 02
        • GSK Investigational Site
  • Egypt
      • Cairo, Egypt
        • GSK Investigational Site
      • Mansoura, Egypt, 35516
        • GSK Investigational Site
      • Shebeen El-Kom, Menoufeya, Egypt, 35111
        • GSK Investigational Site
  • France
      • Besançon, France, 25030
        • GSK Investigational Site
      • Bondy, France, 93140
        • GSK Investigational Site
      • Dijon cedex, France, 21019
        • GSK Investigational Site
      • Grenoble, France, 38043
        • GSK Investigational Site
      • Lille, France, 59037
        • GSK Investigational Site
      • Marseille Cedex 08, France, 13285
        • GSK Investigational Site
      • Orléans, France, 45100
        • GSK Investigational Site
      • Paris Cedex 12, France, 75571
        • GSK Investigational Site
      • Paris Cedex 13, France, 75651
        • GSK Investigational Site
      • Rouen, France, 76000
        • GSK Investigational Site
      • Strasbourg, France, 67091
        • GSK Investigational Site
      • Vandoeuvre Les Nancy, France, 54511
        • GSK Investigational Site
  • Germany
      • Berlin, Germany, 13353
        • GSK Investigational Site
      • Berlin, Germany, 10969
        • GSK Investigational Site
      • Berlin, Germany, 12203
        • GSK Investigational Site
      • Berlin, Germany, 10439
        • GSK Investigational Site
      • Hamburg, Germany, 20246
        • GSK Investigational Site
      • Hamburg, Germany, 20099
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Freiburg, Baden-Wuerttemberg, Germany, 79106
        • GSK Investigational Site
      • Heidelberg, Baden-Wuerttemberg, Germany, 69120
        • GSK Investigational Site
      • Mannheim, Baden-Wuerttemberg, Germany, 68167
        • GSK Investigational Site
      • Stuttgart, Baden-Wuerttemberg, Germany, 70197
        • GSK Investigational Site
      • Ulm, Baden-Wuerttemberg, Germany, 89081
        • GSK Investigational Site
    • Bayern
      • Deggendorf, Bayern, Germany, 94469
        • GSK Investigational Site
      • Hof/Saale, Bayern, Germany, 95028
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 81675
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 81377
        • GSK Investigational Site
      • Regensburg, Bayern, Germany, 93049
        • GSK Investigational Site
      • Wuerzburg, Bayern, Germany, 97080
        • GSK Investigational Site
    • Brandenburg
      • Beeskow, Brandenburg, Germany, 15848
        • GSK Investigational Site
    • Hessen
      • Frankfurt, Hessen, Germany, 60596
        • GSK Investigational Site
      • Frankfurt, Hessen, Germany, 60590
        • GSK Investigational Site
      • Kassel, Hessen, Germany, 34127
        • GSK Investigational Site
    • Niedersachsen
      • Goettingen, Niedersachsen, Germany, 37075
        • GSK Investigational Site
      • Hannover, Niedersachsen, Germany, 30159
        • GSK Investigational Site
      • Hannover, Niedersachsen, Germany, 30625
        • GSK Investigational Site
      • Rotenburg (Wuemme), Niedersachsen, Germany, 27356
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Aachen, Nordrhein-Westfalen, Germany, 52074
        • GSK Investigational Site
      • Bochum, Nordrhein-Westfalen, Germany, 44787
        • GSK Investigational Site
      • Bonn, Nordrhein-Westfalen, Germany, 53127
        • GSK Investigational Site
      • Dortmund, Nordrhein-Westfalen, Germany, 44263
        • GSK Investigational Site
      • Duesseldorf, Nordrhein-Westfalen, Germany, 40225
        • GSK Investigational Site
      • Essen, Nordrhein-Westfalen, Germany, 45122
        • GSK Investigational Site
      • Herne, Nordrhein-Westfalen, Germany, 44623
        • GSK Investigational Site
      • Koeln, Nordrhein-Westfalen, Germany, 50937
        • GSK Investigational Site
      • Leverkusen, Nordrhein-Westfalen, Germany, 51375
        • GSK Investigational Site
      • Muenster, Nordrhein-Westfalen, Germany, 48143
        • GSK Investigational Site
      • Oberhausen, Nordrhein-Westfalen, Germany, 46045
        • GSK Investigational Site
      • Siegen, Nordrhein-Westfalen, Germany, 57072
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55131
        • GSK Investigational Site
    • Sachsen
      • Chemnitz, Sachsen, Germany, 09116
        • GSK Investigational Site
      • Leipzig, Sachsen, Germany, 04129
        • GSK Investigational Site
    • Sachsen-Anhalt
      • Halle, Sachsen-Anhalt, Germany, 06120
        • GSK Investigational Site
      • Magdeburg, Sachsen-Anhalt, Germany, 39120
        • GSK Investigational Site
  • Greece
      • Athens, Greece, 10676
        • GSK Investigational Site
      • Athens, Greece, 115 27
        • GSK Investigational Site
      • Rio, Patras, Greece, 265 04
        • GSK Investigational Site
      • Thessaloniki, Greece, 546 42
        • GSK Investigational Site
  • India
      • Bangalore, India, 560054
        • GSK Investigational Site
      • Chennai, India, 600 096
        • GSK Investigational Site
      • Hyderabad, India, 500082
        • GSK Investigational Site
      • Mumbai, India, 400 008
        • GSK Investigational Site
      • Mumbai, India, 400 016
        • GSK Investigational Site
      • Mumbai, India, 400036
        • GSK Investigational Site
  • Israel
      • Haifa, Israel, 31096
        • GSK Investigational Site
      • Haifa, Israel, 34362
        • GSK Investigational Site
      • Jerusalem, Israel, 91120
        • GSK Investigational Site
      • Nazareth, Israel, 16100
        • GSK Investigational Site
      • Petach Tikva, Israel, 49100
        • GSK Investigational Site
      • Rehovot, Israel, 76100
        • GSK Investigational Site
      • Safed, Israel, 13110
        • GSK Investigational Site
      • Tel Aviv, Israel, 64239
        • GSK Investigational Site
  • Italy
    • Calabria
      • Catanzaro, Calabria, Italy, 88100
        • GSK Investigational Site
    • Campania
      • Avellino, Campania, Italy, 83100
        • GSK Investigational Site
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • GSK Investigational Site
    • Lazio
      • Roma, Lazio, Italy, 00133
        • GSK Investigational Site
    • Liguria
      • Genova, Liguria, Italy, 16132
        • GSK Investigational Site
    • Lombardia
      • Brescia, Lombardia, Italy, 25123
        • GSK Investigational Site
      • Milano, Lombardia, Italy, 20132
        • GSK Investigational Site
      • Milano, Lombardia, Italy, 20157
        • GSK Investigational Site
    • Puglia
      • Bari, Puglia, Italy, 70124
        • GSK Investigational Site
      • San Giovanni Rotondo (FG), Puglia, Italy, 71013
        • GSK Investigational Site
    • Sicilia
      • Palermo, Sicilia, Italy, 90127
        • GSK Investigational Site
  • Korea, Republic of
      • Busan, Korea, Republic of, 614-735
        • GSK Investigational Site
      • Daegu, Korea, Republic of, 700-721
        • GSK Investigational Site
      • Pusan, Korea, Republic of, 602-739
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 120-752
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 135-720
        • GSK Investigational Site
  • Pakistan
      • Lahore, Pakistan, 54600
        • GSK Investigational Site
      • Lahore, Pakistan, 54000
        • GSK Investigational Site
  • Poland
      • Chorzow, Poland, 41-500
        • GSK Investigational Site
      • Kielce, Poland, 25-317
        • GSK Investigational Site
      • Raciborz, Poland, 47-400
        • GSK Investigational Site
      • Szczecin, Poland, 71-455
        • GSK Investigational Site
      • Warszawa, Poland, 01-201
        • GSK Investigational Site
      • Wroclaw, Poland, 51-149
        • GSK Investigational Site
  • Puerto Rico
      • Ponce, Puerto Rico, 00717
        • GSK Investigational Site
      • San Juan, Puerto Rico, 00927
        • GSK Investigational Site
  • Romania
      • Bucharest, Romania, 021105
        • GSK Investigational Site
      • Constanta, Romania, 900709
        • GSK Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 107014
        • GSK Investigational Site
      • Saint-Petersburg, Russian Federation, 191167
        • GSK Investigational Site
      • Samara, Russian Federation, 443011
        • GSK Investigational Site
      • St.Peterburg, Russian Federation, 190103
        • GSK Investigational Site
  • Slovakia
      • Bratislava, Slovakia, 833 05
        • GSK Investigational Site
      • Bratislava, Slovakia, 811 07
        • GSK Investigational Site
      • Kosice, Slovakia, 041 66
        • GSK Investigational Site
      • Martin, Slovakia, 036 59
        • GSK Investigational Site
  • Spain
      • Alicante, Spain, 03010
        • GSK Investigational Site
      • Barcelona, Spain, 08035
        • GSK Investigational Site
      • Barcelona, Spain, 08003
        • GSK Investigational Site
      • La Coruña, Spain, 15006
        • GSK Investigational Site
      • Madrid, Spain, 28006
        • GSK Investigational Site
      • Madrid, Spain, 28007
        • GSK Investigational Site
      • Madrid, Spain, 28034
        • GSK Investigational Site
      • Málaga, Spain, 29010
        • GSK Investigational Site
      • Palma de Mallorca, Spain, 07010
        • GSK Investigational Site
      • Pontevedra, Spain, 36071
        • GSK Investigational Site
      • Sabadell (Barcelona), Spain, 08208
        • GSK Investigational Site
      • San Sebastián, Spain, 20014
        • GSK Investigational Site
      • Sevilla, Spain, 41014
        • GSK Investigational Site
      • Valencia, Spain, 46010
        • GSK Investigational Site
      • Valencia, Spain, 46009
        • GSK Investigational Site
  • Taiwan
      • Changhua, Taiwan, 500
        • GSK Investigational Site
      • Chia-Yi Hsien, Taiwan, 613
        • GSK Investigational Site
      • Kaohsiung, Taiwan, 833
        • GSK Investigational Site
      • Taichung, Taiwan, 404
        • GSK Investigational Site
      • Taipei, Taiwan, 112
        • GSK Investigational Site
      • Taiyuan Hsien, Taiwan, 333
        • GSK Investigational Site
  • Ukraine
      • Donetsk, Ukraine, 83114
        • GSK Investigational Site
      • Kiev, Ukraine, 01030
        • GSK Investigational Site
      • Vinnitsa, Ukraine, 21021
        • GSK Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-0005
        • GSK Investigational Site
    • Arizona
      • Tucson, Arizona, United States, 85750
        • GSK Investigational Site
    • California
      • Anaheim, California, United States, 92801
        • GSK Investigational Site
      • Arcadia, California, United States, 91007
        • GSK Investigational Site
      • La Jolla, California, United States, 92037
        • GSK Investigational Site
      • Los Angeles, California, United States, 90017
        • GSK Investigational Site
      • Los Angeles, California, United States, 90048
        • GSK Investigational Site
      • Lynwood, California, United States, 90262
        • GSK Investigational Site
      • Sacramento, California, United States, 95817
        • GSK Investigational Site
      • San Clemente, California, United States, 92673
        • GSK Investigational Site
      • San Diego, California, United States, 92123
        • GSK Investigational Site
      • San Mateo, California, United States, 94403
        • GSK Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • GSK Investigational Site
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • GSK Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • GSK Investigational Site
      • Washington, District of Columbia, United States, 20307
        • GSK Investigational Site
    • Florida
      • Bradenton, Florida, United States, 34209
        • GSK Investigational Site
      • Jacksonville, Florida, United States, 32207
        • GSK Investigational Site
      • Miami, Florida, United States, 33125
        • GSK Investigational Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60612-3824
        • GSK Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • GSK Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • GSK Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • GSK Investigational Site
      • Burlington, Massachusetts, United States, 01805
        • GSK Investigational Site
      • Worcester, Massachusetts, United States, 01655
        • GSK Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • GSK Investigational Site
      • Detroit, Michigan, United States, 48201
        • GSK Investigational Site
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • GSK Investigational Site
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • GSK Investigational Site
      • St. Louis, Missouri, United States, 63104
        • GSK Investigational Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • GSK Investigational Site
    • New York
      • Bronx, New York, United States, 10468
        • GSK Investigational Site
      • Manhasset, New York, United States, 11030
        • GSK Investigational Site
      • New York, New York, United States, 10021
        • GSK Investigational Site
      • New York, New York, United States, 10016
        • GSK Investigational Site
      • Rochester, New York, United States, 14642
        • GSK Investigational Site
      • Syracuse, New York, United States, 13210
        • GSK Investigational Site
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • GSK Investigational Site
      • Durham, North Carolina, United States, 27710
        • GSK Investigational Site
      • Kinston, North Carolina, United States, 28501
        • GSK Investigational Site
      • Morganton, North Carolina, United States, 28655
        • GSK Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • GSK Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • GSK Investigational Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033-0850
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, United States, 19104
        • GSK Investigational Site
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • GSK Investigational Site
      • Mountain Home, Tennessee, United States, 37684
        • GSK Investigational Site
      • Nashville, Tennessee, United States, 37212
        • GSK Investigational Site
      • Nashville, Tennessee, United States, 37203
        • GSK Investigational Site
      • Nashville, Tennessee, United States, 37205
        • GSK Investigational Site
    • Texas
      • Dallas, Texas, United States, 75203
        • GSK Investigational Site
      • Galveston, Texas, United States, 77555-0435
        • GSK Investigational Site
      • Houston, Texas, United States, 77030
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78215
        • GSK Investigational Site
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • GSK Investigational Site
      • Richmond, Virginia, United States, 23249
        • GSK Investigational Site
    • Washington
      • Seattle, Washington, United States, 98111
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Male and female subjects, >18 years Evidence of chronic hepatitis C virus (HCV) infection Subjects who are appropriate candidates for peginterferon (pegIFN) and ribavirin antiviral therapy A platelet count of <75,000/mcL Haemoglobin >11.0g/dL for men or >10.0g/dL for women Absolute neutrophil count (ANC) >750/mm3 and no history of infections associated with neutropenia Creatinine clearance >50mL/minute All fertile males and females must use two forms of effective contraception between them during treatment and during the 24 weeks after treatment end Subject is able to understand, consent and comply with protocol requirements and instructions and is likely to complete the study as planned

Exclusion criteria:

Non-responders to previous treatment with pegIFN and ribavirin who failed to achieve a sustained virologic response (SVR) for reasons other than thrombocytopenia, despite an optimal course (dose and duration) of combination therapy with pegIFN and ribavirin Decompensated liver disease, e.g. Child-Pugh score >6 or history of ascites or hepatic encephalopathy or current evidence of ascites Known hypersensitivity, intolerance or allergy to interferon (IFN), ribavirin, eltrombopag or any of their ingredients Serious cardiac, cerebrovascular, or pulmonary disease that would preclude treatment with pegIFN and ribavirin

Subjects with a history of any one of the following:

Suicide attempt or hospitalisation for depression in the past 5 years Any current severe or poorly controlled psychiatric disorder

The following subjects are eligible for study participation, but must be assessed and followed (if recommended) by a mental health professional:

  • Subjects who have had a severe or poorly controlled psychiatric disorder more than 6 months ago but less than 5 years ago
  • Seizure disorder that has not been well controlled History of clinically significant bleeding from oesophageal or gastric varices Subjects with haemoglobinopathies, e.g. sickle cell anaemia, thalassemia major Any prior history of arterial or venous thrombosis AND two or more of the following risk factors: hereditary thrombophilic disorders (e.g. Factor V Leiden, ATIII deficiency, etc), hormone replacement therapy, systemic contraception (containing estrogen), smoking, diabetes, hypercholesterolemia, medication for hypertension or cancer Pre-existing cardiac disease (New York Heart Association (NYHA) Grade III/IV), or arrhythmias known to involve the risk of thromboembolic events, or corrected QT interval (QTc) >450 msec Evidence of hepatocellular carcinoma Laboratory evidence of infection with human immunodeficiency virus (HIV) or active Hepatitis B Virus (HBV) infection Any disease condition associated with active bleeding or requiring anticoagulation with heparin or warfarin Therapy with any anti-neoplastic or immuno-modulatory treatment <6 months prior to the first dose of eltrombopag.

Subjects who have had a malignancy diagnosed and/or treated within the past 5 years, except for subjects with localised basal or squamous cell carcinoma treated by local excision or subjects with malignancies who have been adequately treated and, in the opinion of the oncologist, have an excellent chance of cancer-free survival Pregnant or nursing women Males with a female partner who is pregnant History of alcohol/drug abuse or dependence within 6 months of the study start (unless participating in a controlled rehabilitation programme) Treatment with an investigational drug or IFN within 30 days or 5 half-lives (whichever is longer) of the screening visit History of platelet clumping that prevents reliable measurement of platelet counts History of major organ transplantation with an existing functional graft Thyroid dysfunction not adequately controlled Subjects planning to have cataract surgery Evidence of portal vein thrombosis on abdominal imaging within 3 months of the baseline visit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: eltrombopag
active treatment arm
Drug: eltrombopag
double-blind active treatment daily oral administation at dose of 25, 50, 75, or 100 mg
Placebo Comparator: placebo
placebo control arm
Drug: placebo
double-blind matched placebo control daily oral administration

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Sustained Virologic Response (SVR) in the Double-blind (DB) Antiviral Treatment Phase
Time Frame: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Participants with SVR are defined as those with non-detectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at the end of treatment and all subsequent planned visits up to 24 weeks post-completion of the treatment period of the DB Phase.
From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants Whose Platelet Count Increased From a Baseline Count of <75 Gi/L to a Count Greater Than or Equal to (>=) 100 Giga (10^9) Cells Per Liter (Gi/L) During the Open-label (OL) Pre-Antiviral Treatment Phase
Time Frame: From Baseline up to Week 9 in the OL Phase
Participants were assessed for a shift from a baseline platelet count of <75 Gi/L to a count >=100 Gi/L during the OL Phase (up to 9 weeks). Local laboratories were used for platelet function tests. Platelet counts were measured by blood draw.
From Baseline up to Week 9 in the OL Phase
Number of Participants Receiving the Indicated Doses of Eltrombopag in the OL Phase Who Initiated Antiviral Therapy (Peginterferon Alfa-2a and Ribavirin) in the DB Phase
Time Frame: From Baseline up to Week 9 in the OL Phase
In the OL Phase, participants initially received the lowest dose of eltrombopag (25 mg QD) for 2 weeks. If after this time the platelet count was <100 Gi/L, participants underwent sequential dose escalation to the next highest dose (50 mg QD for up to 2 weeks), with further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) if platelet counts remained <100 Gi/L. Participants who achieved platelet counts >=100 Gi/L when receiving any of the eltrombopag doses in the OL Phase initiated antiviral therapy in the DB Phase.
From Baseline up to Week 9 in the OL Phase
Median Platelet Count at the Indicated Time Points During the OL Phase
Time Frame: OL Phase: Baseline; Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, and 9; Antiviral Baseline (up to Week 10); End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 62); 12-week FU (up to Week 70); and 24-week FU (up to Week 82)
Blood taken from peripheral blood vessels was used for the measurement of platelet counts. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator.
OL Phase: Baseline; Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, and 9; Antiviral Baseline (up to Week 10); End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 62); 12-week FU (up to Week 70); and 24-week FU (up to Week 82)
Median Platelet Count at the Indicated Time Points During the DB Phase
Time Frame: DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)
Blood taken from peripheral blood vessels was used for the measurement of platelet counts. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator.
DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)
Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy
Time Frame: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
The minimum platelet count with antiviral therapy was categorized as follows: <25 Gi/L; >=25 to <50 Gi/L; >=50 to <90 Gi/L; >=90 to <150 Gi/L; >=150 Gi/L to <200 Gi/L; >=200 Gi/L to <400 Gi/L; and >=400 Gi/L.
From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) During the DB Phase
Time Frame: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
RVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment. eRVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment that persisted through Week 12.
From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) During the DB Phase
Time Frame: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
EVR is defined as a clinically significant reduction from Baseline in HCV RNA (>=2 log10 drop or undetectable) after 12 weeks of antiviral treatment. cEVR is defined as undetectable HCV RNA after 12 weeks of antiviral treatment.
From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Number of Participants With End of Treatment Response (ETR) and Sustained Virological Response at Week 12 of Follow-up (SVR12) During the DB Phase
Time Frame: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
ETR is defined as the absence of detectable HCV RNA at the end of antiviral treatment. SVR12 is defined as the absence of detectable HCV RNA at the end of antiviral treatment and the 12-week follow-up assessment.
From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Number of Participants in the Indicated Categories for Antiviral Therapy Dose Reductions in the DB Phase
Time Frame: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Participants were assigned a score equal to the number of times their dose of antiviral therapy (peginterferon or ribavirin) was reduced (0=no dose reductions [DRs]; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). When possible, every effort was made to maintain the recommended dose of antiviral therapy for the treatment duration in the DB Phase. However, when dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of peginterferon and ribavirin.
From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Time to First Dose Reduction of Peginterferon Alfa-2a and Ribavirin Therapy in the DB Phase
Time Frame: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Time to first dose reduction was calculated as the time period from the first dose to the first dose reduction.
From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Number of Participants With the Indicated Levels of Peginterferon Dose Reductions in the DB Phase
Time Frame: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
The assigned dose in the DB Phase of peginterferon alfa-2a was 180 micrograms (µg). For peginterferon dose modification, downward adjustments in one-level increments were considered. The lowest dose of peginterferon alfa-2a that was allowed to be administered was 45 µg. When dose adjustment was required for moderate to severe adverse reactions (clinical and/or laboratory), an initial dose reduction to 135 µg was generally adequate. In some cases, a dose reduction to 90 µg or 45 µg was necessary. Dose increases toward the original dose were considered when the adverse reaction was resolved.
From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Number of Participants Who Prematurely Discontinued Antiviral Therapy in the DB Phase
Time Frame: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
The following participants were considered to have discontinued antiviral therapy: participants who were lost to follow-up; participants who withdrew for any reason; participants who died; participants who otherwise did not complete their planned course of antiviral therapy for any reason. The planned duration of antiviral therapy was 48 weeks for participants with Non-Genotype 2/3 and 24 or 48 weeks for participants with Genotype 2/3.
From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3)
Time Frame: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
There are two genetic variants (rs12979860 and rs8099917) mapping near IL28B associated with both interferon-induced SVR and spontaneous HCV clearance. IL28B genotype distribution by response to antiviral therapy (SVR/RVR responders: those who achieved SVR/RVR; SVR/RVR non-responders: those who did not achieve SVR/RVR) was assessed. The effect of genotype was tested by comparing participants that carried 2 copies of the IL28B favorable response allele versus the others (recessive model). Genotypes at rs12979860 were coded as: CC=1, CT or TT=0; rs8099917 was coded as TT=1, GT or GG=0.
From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS)
Time Frame: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Blood samples for the assessment of clinical chemistry parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of calcium (low=hypocalcemia; high=hypercalcemia), glu. (low=hypoglycemia; high=hyperglycemia), pot. (low=hypokalemia; high=hyperkalemia), and sod. (low=hyponatremia; high=hypernatremia). Per the DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.
From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS
Time Frame: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.
From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication
Time Frame: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Ophthalmic (pertaining to eye) assessments were performed during the study. A cataract event is defined as an event ascertained to be a cataract (opacity or cloudiness of the lens of the eye, causing impairment of vision) by at least one of the CEC members (comprised of expert ophthalmologists who provided objective medical review of the blinded ophthalmic data). Per the CEC, cataract events were categorized as: (1) Cataract Progression (CP; progression of cataracts present at BL); and (2) Incident Cataract (IC; development of new cataracts). One eye=unilateral; both eyes=bilateral.
From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase
Time Frame: DB Phase: Antiviral BL (up to Week 10); End of Treatment (up to Week 52); and 24-week FU (up to Week 72)
Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The number of participants with an ECG status of normal, abnormal, CS, or NCS, as determined by the Investigator, was reported. Normal, all ECG parameters within accepted normal ranges. Abnormal, ECG finding(s) outside of normal ranges. CS, ECG with a CS abnormality that meets exclusion criteria. NCS, ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment.
DB Phase: Antiviral BL (up to Week 10); End of Treatment (up to Week 52); and 24-week FU (up to Week 72)
Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB Phase
Time Frame: End of Treatment (up to Week 52); and 24-week FU (up to Week 72)
Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The number of participants with a CS and a NCS change from baseline in ECG status, as determined by the Investigator, was reported. CS, ECG with a CS abnormality that meets exclusion criteria. NCS, ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment. "Not applicable" indicates that information was not provided by the investigator on whether the change from baseline ECG was CS or NCS.
End of Treatment (up to Week 52); and 24-week FU (up to Week 72)
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase
Time Frame: DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)
Participant's blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.
DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)
Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase
Time Frame: DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)
Heart rate was measured in participants at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.
DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)
Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase
Time Frame: DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)
The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.
DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)
Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase
Time Frame: DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)
The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.
DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)

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Sponsor

Sponsor

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GlaxoSmithKline

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General Publications

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October 1, 2007

Primary Completion (Actual)

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August 1, 2011

Study Completion (Actual)

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August 1, 2011

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First Submitted

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September 12, 2007

First Submitted That Met QC Criteria

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September 12, 2007

First Posted (Estimate)

First Posted

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September 14, 2007

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November 5, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

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October 10, 2013

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March 1, 2013

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  • TPL108390

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