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

10 oktober 2013 uppdaterad av: 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-2a 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).

Studieöversikt

Status

Avslutad

Betingelser

Hepatit C, kronisk

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

687

Fas

Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Australien
- Australian Capital Territory
  - Garran, Australian Capital Territory, Australien, 2606
    - GSK Investigational Site
- New South Wales
  - Camperdown, New South Wales, Australien, 2050
    - GSK Investigational Site
  - Randwick, New South Wales, Australien, 2031
    - GSK Investigational Site
- Victoria
  - Fitzroy, Victoria, Australien, 3065
    - GSK Investigational Site
  - Heidelberg, Victoria, Australien, 3084
    - GSK Investigational Site
  - Melbourne, Victoria, Australien, 3168
    - GSK Investigational Site
- Western Australia
  - Nedlands, Western Australia, Australien, 6009
    - GSK Investigational Site
Belgien
- - Bruxelles, Belgien, 1200
    - GSK Investigational Site
  - Edegem, Belgien, 2650
    - GSK Investigational Site
  - Gent, Belgien, 9000
    - GSK Investigational Site
  - Leuven, Belgien, 3000
    - GSK Investigational Site
Brasilien
- - São Paulo, Brasilien, 04023900
    - GSK Investigational Site
- São Paulo
  - Campinas, São Paulo, Brasilien, 13083-888
    - GSK Investigational Site
Frankrike
- - Besançon, Frankrike, 25030
    - GSK Investigational Site
  - Dijon cedex, Frankrike, 21019
    - GSK Investigational Site
  - Marseille, Frankrike, 13385
    - GSK Investigational Site
  - Montpellier, Frankrike, 34295
    - GSK Investigational Site
  - Nice, Frankrike, 06202
    - GSK Investigational Site
  - Pessac Cedex, Frankrike, 33604
    - GSK Investigational Site
  - Strasbourg, Frankrike, 67091
    - GSK Investigational Site
  - Toulouse, Frankrike, 31300
    - GSK Investigational Site
  - Toulouse cedex 9, Frankrike, 31059
    - GSK Investigational Site
Förenta staterna
- Alabama
  - Birmingham, Alabama, Förenta staterna, 35294-0005
    - GSK Investigational Site
- Arizona
  - Tucson, Arizona, Förenta staterna, 85750
    - GSK Investigational Site
- Arkansas
  - Little Rock, Arkansas, Förenta staterna, 72205-7199
    - GSK Investigational Site
- California
  - La Jolla, California, Förenta staterna, 92037
    - GSK Investigational Site
  - Los Angeles, California, Förenta staterna, 90017
    - GSK Investigational Site
  - Los Angeles, California, Förenta staterna, 90048
    - GSK Investigational Site
  - San Clemente, California, Förenta staterna, 92673
    - GSK Investigational Site
- Colorado
  - Aurora, Colorado, Förenta staterna, 80045
    - GSK Investigational Site
- Connecticut
  - New Haven, Connecticut, Förenta staterna, 06520
    - GSK Investigational Site
- District of Columbia
  - Washington, District of Columbia, Förenta staterna, 20010
    - GSK Investigational Site
  - Washington, District of Columbia, Förenta staterna, 20307
    - GSK Investigational Site
- Florida
  - Bradenton, Florida, Förenta staterna, 34209
    - GSK Investigational Site
  - Gainsville, Florida, Förenta staterna, 32610
    - GSK Investigational Site
  - Miami, Florida, Förenta staterna, 33136
    - GSK Investigational Site
  - Orlando, Florida, Förenta staterna, 32803
    - GSK Investigational Site
- Georgia
  - Atlanta, Georgia, Förenta staterna, 30309
    - GSK Investigational Site
- Hawaii
  - Honolulu, Hawaii, Förenta staterna, 96817
    - GSK Investigational Site
- Kentucky
  - Louisville, Kentucky, Förenta staterna, 40202
    - GSK Investigational Site
- Maryland
  - Baltimore, Maryland, Förenta staterna, 21202
    - GSK Investigational Site
- Massachusetts
  - Burlington, Massachusetts, Förenta staterna, 01805
    - GSK Investigational Site
  - Worcester, Massachusetts, Förenta staterna, 01655
    - GSK Investigational Site
- Michigan
  - Ann Arbor, Michigan, Förenta staterna, 48109
    - GSK Investigational Site
  - Detroit, Michigan, Förenta staterna, 48201
    - GSK Investigational Site
- Mississippi
  - Jackson, Mississippi, Förenta staterna, 39202
    - GSK Investigational Site
- Missouri
  - St. Louis, Missouri, Förenta staterna, 63110
    - GSK Investigational Site
- New York
  - Bronx, New York, Förenta staterna, 10468
    - GSK Investigational Site
  - Manhasset, New York, Förenta staterna, 11030
    - GSK Investigational Site
  - New York, New York, Förenta staterna, 10021
    - GSK Investigational Site
  - Rochester, New York, Förenta staterna, 14642
    - GSK Investigational Site
  - Syracuse, New York, Förenta staterna, 13210
    - GSK Investigational Site
  - Valhalla, New York, Förenta staterna, 10595
    - GSK Investigational Site
- North Carolina
  - Asheville, North Carolina, Förenta staterna, 28801
    - GSK Investigational Site
  - Durham, North Carolina, Förenta staterna, 27705
    - GSK Investigational Site
- Oklahoma
  - Tulsa, Oklahoma, Förenta staterna, 74104
    - GSK Investigational Site
- Oregon
  - Portland, Oregon, Förenta staterna, 97239
    - GSK Investigational Site
- Pennsylvania
  - Hershey, Pennsylvania, Förenta staterna, 17033-0850
    - GSK Investigational Site
  - Philadelphia, Pennsylvania, Förenta staterna, 19104
    - GSK Investigational Site
- Tennessee
  - Jackson, Tennessee, Förenta staterna, 38301
    - GSK Investigational Site
  - Nashville, Tennessee, Förenta staterna, 37212
    - GSK Investigational Site
  - Nashville, Tennessee, Förenta staterna, 37203
    - GSK Investigational Site
  - Nashville, Tennessee, Förenta staterna, 37205
    - GSK Investigational Site
- Texas
  - Galveston, Texas, Förenta staterna, 77555-0435
    - GSK Investigational Site
  - Houston, Texas, Förenta staterna, 77030
    - GSK Investigational Site
  - San Antonio, Texas, Förenta staterna, 78215
    - GSK Investigational Site
- Virginia
  - Charlottesville, Virginia, Förenta staterna, 22908
    - GSK Investigational Site
  - Fairfax, Virginia, Förenta staterna, 22031
    - GSK Investigational Site
  - Richmond, Virginia, Förenta staterna, 23249
    - GSK Investigational Site
Hong Kong
- - Pokfulam, Hong Kong
    - GSK Investigational Site
Indien
- - Bangalore, Indien
    - GSK Investigational Site
  - Chennai, Indien, 600 096
    - GSK Investigational Site
  - Mumbai, Indien, 400036
    - GSK Investigational Site
Israel
- - Haifa, Israel, 31096
    - GSK Investigational Site
  - Jerusalem, Israel, 91120
    - GSK Investigational Site
  - Petach Tikva, Israel, 49100
    - GSK Investigational Site
  - Safed, Israel, 13110
    - GSK Investigational Site
  - Tel Aviv, Israel, 64239
    - GSK Investigational Site
Italien
- Calabria
  - Catanzaro, Calabria, Italien, 88100
    - GSK Investigational Site
- Campania
  - Avellino, Campania, Italien, 83100
    - GSK Investigational Site
- Emilia-Romagna
  - Bologna, Emilia-Romagna, Italien, 40138
    - GSK Investigational Site
- Lazio
  - Roma, Lazio, Italien, 00133
    - GSK Investigational Site
- Liguria
  - Genova, Liguria, Italien, 16132
    - GSK Investigational Site
- Lombardia
  - Brescia, Lombardia, Italien, 25123
    - GSK Investigational Site
  - Milano, Lombardia, Italien, 20132
    - GSK Investigational Site
  - Milano, Lombardia, Italien, 20157
    - GSK Investigational Site
- Puglia
  - Bari, Puglia, Italien, 70124
    - GSK Investigational Site
  - San Giovanni Rotondo (FG), Puglia, Italien, 71013
    - GSK Investigational Site
- Sicilia
  - Palermo, Sicilia, Italien, 90127
    - GSK Investigational Site
Kanada
- Alberta
  - Calgary, Alberta, Kanada, T2N 4Z6
    - GSK Investigational Site
- British Columbia
  - Victoria, British Columbia, Kanada, V8V 3P9
    - GSK Investigational Site
- Manitoba
  - Winnipeg, Manitoba, Kanada, R3E 3P4
    - GSK Investigational Site
- Ontario
  - Barrie, Ontario, Kanada, L4M 7G1
    - GSK Investigational Site
  - Hamilton, Ontario, Kanada, L8N 4A6
    - GSK Investigational Site
  - Hamilton, Ontario, Kanada, L8L 2X2
    - GSK Investigational Site
  - Ottawa, Ontario, Kanada, K1N 6N5
    - GSK Investigational Site
  - Ottawa, Ontario, Kanada, K1H 8L6
    - GSK Investigational Site
  - Toronto, Ontario, Kanada, M5T 2S8
    - GSK Investigational Site
  - Toronto, Ontario, Kanada, M5G 1X5
    - GSK Investigational Site
  - Toronto, Ontario, Kanada, M5G 2C4
    - GSK Investigational Site
  - Toronto, Ontario, Kanada, M6H 3M1
    - GSK Investigational Site
- Quebec
  - Montreal, Quebec, Kanada, H2X 2P4
    - GSK Investigational Site
  - Montreal, Quebec, Kanada, H2X 3J4
    - GSK Investigational Site
Korea, Republiken av
- - Busan, Korea, Republiken av, 614-735
    - GSK Investigational Site
  - Incheon, Korea, Republiken av, 400-711
    - GSK Investigational Site
  - Seoul, Korea, Republiken av, 135-710
    - GSK Investigational Site
Nederländerna
- - Amsterdam, Nederländerna, 1081 HV
    - GSK Investigational Site
  - Nijmegen, Nederländerna, 6525 GA
    - GSK Investigational Site
  - Rotterdam, Nederländerna, 3015 CE
    - GSK Investigational Site
Pakistan
- - Lahore, Pakistan, 54600
    - GSK Investigational Site
  - Lahore, Pakistan, 54000
    - GSK Investigational Site
Polen
- - Bydgoszcz, Polen, 85-030
    - GSK Investigational Site
  - Chorzow, Polen, 41-500
    - GSK Investigational Site
  - Kielce, Polen, 25-317
    - GSK Investigational Site
  - Szczecin, Polen, 71-455
    - GSK Investigational Site
  - Wroclaw, Polen, 51-149
    - GSK Investigational Site
Puerto Rico
- - Ponce, Puerto Rico, 00717
    - GSK Investigational Site
  - San Juan, Puerto Rico, 00927
    - GSK Investigational Site
Rumänien
- - Bucharest, Rumänien, 021105
    - GSK Investigational Site
  - Constanta, Rumänien, 900708
    - GSK Investigational Site
Ryska Federationen
- - Moscow, Ryska Federationen, 129110
    - GSK Investigational Site
  - Moscow, Ryska Federationen, 110020
    - GSK Investigational Site
  - Mosocow, Ryska Federationen, 117593
    - GSK Investigational Site
  - Smolensk, Ryska Federationen, 214018
    - GSK Investigational Site
Slovakien
- - Bratislava, Slovakien, 833 05
    - GSK Investigational Site
  - Bratislava, Slovakien, 811 07
    - GSK Investigational Site
  - Kosice, Slovakien, 041 66
    - GSK Investigational Site
  - Martin, Slovakien, 036 59
    - GSK Investigational Site
Spanien
- - Barcelona, Spanien, 08025
    - GSK Investigational Site
  - Granada, Spanien, 18012
    - GSK Investigational Site
  - L'Hospitalet de Llobregat. Barcelona, Spanien, 08907
    - GSK Investigational Site
  - La Coruña, Spanien, 15006
    - GSK Investigational Site
  - Madrid, Spanien, 28006
    - GSK Investigational Site
  - Madrid, Spanien, 28007
    - GSK Investigational Site
  - Madrid, Spanien, 28034
    - GSK Investigational Site
  - Madrid, Spanien, 28029
    - GSK Investigational Site
  - San Sebastián, Spanien, 20014
    - GSK Investigational Site
  - Sevilla, Spanien, 41014
    - GSK Investigational Site
  - Valencia, Spanien, 46010
    - GSK Investigational Site
Storbritannien
- - London, Storbritannien, NW3 2QG
    - GSK Investigational Site
  - London, Storbritannien, W2 1NY
    - GSK Investigational Site
  - Plymouth, Storbritannien, PL6 8DH
    - GSK Investigational Site
- Lanarkshire
  - Glasgow, Lanarkshire, Storbritannien, G12 0YN
    - GSK Investigational Site
Taiwan
- - Kaohsiung, Taiwan, 80708
    - GSK Investigational Site
  - Taichung, Taiwan, 407
    - GSK Investigational Site
  - Tainan, Taiwan, 704
    - GSK Investigational Site
  - Taipei, Taiwan, 100
    - GSK Investigational Site
Thailand
- - Bangkok, Thailand, 10330
    - GSK Investigational Site
  - Bangkok, Thailand, 10700
    - GSK Investigational Site
  - Chiangmai, Thailand, 50200
    - GSK Investigational Site
  - Khon Kaen, Thailand, 40002
    - GSK Investigational Site
  - Songkla, Thailand, 90110
    - GSK Investigational Site
Tjeckien
- - Praha 4, Tjeckien, 140 21
    - GSK Investigational Site
  - Praha 6, Tjeckien, 169 02
    - GSK Investigational Site
Tyskland
- - Berlin, Tyskland, 13353
    - GSK Investigational Site
  - Berlin, Tyskland, 12203
    - GSK Investigational Site
- Baden-Wuerttemberg
  - Freiburg, Baden-Wuerttemberg, Tyskland, 79106
    - GSK Investigational Site
  - Heidelberg, Baden-Wuerttemberg, Tyskland, 69120
    - GSK Investigational Site
  - Stuttgart, Baden-Wuerttemberg, Tyskland, 70197
    - GSK Investigational Site
  - Ulm, Baden-Wuerttemberg, Tyskland, 89081
    - GSK Investigational Site
- Bayern
  - Deggendorf, Bayern, Tyskland, 94469
    - GSK Investigational Site
  - Hof/Saale, Bayern, Tyskland, 95028
    - GSK Investigational Site
  - Muenchen, Bayern, Tyskland, 81377
    - GSK Investigational Site
  - Regensburg, Bayern, Tyskland, 93053
    - GSK Investigational Site
  - Wuerzburg, Bayern, Tyskland, 97080
    - GSK Investigational Site
- Brandenburg
  - Beeskow, Brandenburg, Tyskland, 15848
    - GSK Investigational Site
- Hessen
  - Frankfurt, Hessen, Tyskland, 60590
    - GSK Investigational Site
  - Kassel, Hessen, Tyskland, 34127
    - GSK Investigational Site
- Niedersachsen
  - Goettingen, Niedersachsen, Tyskland, 37075
    - GSK Investigational Site
  - Hannover, Niedersachsen, Tyskland, 30159
    - GSK Investigational Site
  - Hannover, Niedersachsen, Tyskland, 30625
    - GSK Investigational Site
- Nordrhein-Westfalen
  - Aachen, Nordrhein-Westfalen, Tyskland, 52074
    - GSK Investigational Site
  - Bochum, Nordrhein-Westfalen, Tyskland, 44787
    - GSK Investigational Site
  - Bonn, Nordrhein-Westfalen, Tyskland, 53127
    - GSK Investigational Site
  - Dortmund, Nordrhein-Westfalen, Tyskland, 44263
    - GSK Investigational Site
  - Duesseldorf, Nordrhein-Westfalen, Tyskland, 40225
    - GSK Investigational Site
  - Essen, Nordrhein-Westfalen, Tyskland, 45122
    - GSK Investigational Site
  - Herne, Nordrhein-Westfalen, Tyskland, 44623
    - GSK Investigational Site
  - Koeln, Nordrhein-Westfalen, Tyskland, 50937
    - GSK Investigational Site
  - Leverkusen, Nordrhein-Westfalen, Tyskland, 51375
    - GSK Investigational Site
  - Muenster, Nordrhein-Westfalen, Tyskland, 48143
    - GSK Investigational Site
  - Siegen, Nordrhein-Westfalen, Tyskland, 57072
    - GSK Investigational Site
- Rheinland-Pfalz
  - Mainz, Rheinland-Pfalz, Tyskland, 55131
    - GSK Investigational Site
- Sachsen
  - Leipzig, Sachsen, Tyskland, 04103
    - GSK Investigational Site
  - Leipzig, Sachsen, Tyskland, 04129
    - GSK Investigational Site
- Sachsen-Anhalt
  - Halle, Sachsen-Anhalt, Tyskland, 06120
    - GSK Investigational Site
  - Magdeburg, Sachsen-Anhalt, Tyskland, 39120
    - GSK Investigational Site
Ukraina
- - Donetsk, Ukraina, 83114
    - GSK Investigational Site
  - Kyiv, Ukraina, 04112
    - GSK Investigational Site
  - Kyiv, Ukraina, 01030
    - GSK Investigational Site
  - Vinnytsia, Ukraina, 21021
    - GSK Investigational Site

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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, antithrombin III (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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Primärt syfte: Behandling
Tilldelning: Randomiserad
Interventionsmodell: Parallellt uppdrag
Maskning: Fyrdubbla

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Number of Participants With Sustained Virologic Response (SVR) in the Double-blind (DB) Antiviral Treatment Phase Tidsram: 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 were defined as those with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 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)

Sekundära resultatmått

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

GlaxoSmithKline

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 oktober 2007

Primärt slutförande (Faktisk)

1 april 2011

Avslutad studie (Faktisk)

1 maj 2011

Studieregistreringsdatum

Först inskickad

13 augusti 2007

Först inskickad som uppfyllde QC-kriterierna

13 augusti 2007

Första postat (Uppskatta)

15 augusti 2007

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

5 november 2013

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 oktober 2013

Senast verifierad

1 augusti 2012

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

TPL103922

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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Clínica de Oftalmología de Cali S.A

Avslutad

iLux-behandling för Meibomian körteldysfunktion (MGD)

Meibomisk körteldysfunktion | Eyes Dry Chronic

Colombia
Alcon Research

Avslutad

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Förenta staterna
Jules Bordet Institute
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Rekrytering

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Belgien
Dhulikhel Hospital
Kathmandu University School of Medical Sciences

Indragen

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Nepal
Dokuz Eylul University
Ege University

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Effekten av maximal träning på MMP9 och TIMP1 och rollen för MMP9 -1562 C/T och TIMP1 372 T/C polymorfismer

MMP9 | TIMP1 | MMP9 -1562 C/T | TIMP1 372 T/C

Kalkon
Tripep AB
Inovio Pharmaceuticals

Okänd

Fas I/IIa Dosintervall CHRONVAC-C®-studie på kroniska HCV-patienter

Kronisk hepatit C-virusinfektion

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XTL Biopharmaceuticals

Indragen

Säkerhet, tolerabilitet och effekt av XTL 2125 hos HCV-infekterade patienter som är interferon-alfa-icke-svarare eller återfall

Kronisk hepatit C-virusinfektion

Israel
Hadassah Medical Organization

Okänd

Methacetin andningstest hos HCV-patienter med normal och nästan normal ALAT

Kronisk hepatit C-virusinfektion

Israel
Johann Wolfgang Goethe University Hospital

Avslutad

Omedelbar bindning och kejsarsnitt

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Tyskland
Trek Therapeutics, PBC

Avslutad

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Kliniska prövningar på eltrombopag

Novartis Pharmaceuticals

Avslutad

En långsiktig säkerhetsstudie av Eltrombopag hos pediatriska patienter med kronisk immun (idiopatisk) trombocytopen purpura (ITP)

Purpura, Trombocytopenisk, Idiopatisk

Ryska Federationen
Weill Medical College of Cornell University
Novartis

Avslutad

Slut på FÖRLÄNGNING: Avbrytande av medicinering för patienter med immun trombocytopeni

Immun trombocytopeni

Förenta staterna
Institute of Hematology & Blood Diseases Hospital...
Xijing Hospital; Xi'an Central Hospital; The Second Hospital of Hebei Medical... och andra samarbetspartners

Aktiv, inte rekryterande

En randomiserad studie som jämför optimerad rhTPO-behandling med Eltrombopag-behandling i förbehandlade ITP-punkter (TE-ITP)

Tidigare behandlad primär immun trombocytopeni

Kina
Tel-Aviv Sourasky Medical Center
Novartis

Rekrytering

Eltrombopag-behandling hos patienter med långvarig BM-toxicitet efter CART

B-cellslymfom | CART-behandling

Israel
Gruppo Italiano Malattie EMatologiche dell'Adulto

Avslutad

Eltrombopag i andra linjens primära immuntrombosytopeni för vuxna

Primacy immun trombocytopeni

Italien
Novartis Pharmaceuticals

Avslutad

Utredning av droganvändning för REVOLADE (ITP)

Purpura, trombocytopen, idiopatisk
Assiut University

Okänd

Eltrombopag i kronisk ITP

Immun trombocytopeni
Nanfang Hospital of Southern Medical University
Guangzhou First People's Hospital; Second Affiliated Hospital, Sun Yat-Sen... och andra samarbetspartners

Okänd

Eltrombopag används vid trombocytopeni efter konsolideringsterapi vid AML

Akut myeloid leukemi | Trombocytopeni | Eltrombopag

Kina
IRCCS Policlinico S. Matteo

Avslutad

Eltrombopag för ärftlig trombocytopeni

Ärftlig blodplättssjukdom

Italien
Dana-Farber Cancer Institute

Avslutad

Eltrombopag för trombocytopeni hos patienter med återfallande multipelt myelom

Multipelt myelom | Trombocytopeni

Förenta staterna

Resultatmått	Åtgärdsbeskrivning	Tidsram
Mediantal av trombocyter vid de angivna tidpunkterna under OL-fasen Tidsram: OL-fas: Baslinje; Dag 1; Vecka 1, 2, 3, 4, 5, 6, 7, 8 och 9; Antiviral baslinje (upp till vecka 10); Slut på behandling (upp till vecka 48); 4-veckors uppföljning (FU) (upp till vecka 62); 12 veckors FU (upp till vecka 70); och 24-veckors FU (upp till vecka 82)	Blod som tagits från perifera blodkärl användes för att mäta antalet blodplättar. Senaste behandlingsbedömningen hänvisar till den faktiska senaste behandlingsbedömningen, inte nödvändigtvis till bedömningen av avslutad behandling som utredaren har angett.	OL-fas: Baslinje; Dag 1; Vecka 1, 2, 3, 4, 5, 6, 7, 8 och 9; Antiviral baslinje (upp till vecka 10); Slut på behandling (upp till vecka 48); 4-veckors uppföljning (FU) (upp till vecka 62); 12 veckors FU (upp till vecka 70); och 24-veckors FU (upp till vecka 82)
Tid till första dosreduktion av Peginterferon Alfa-2a och Ribavirinterapi i DB-fasen Tidsram: Från baslinje upp till vecka 48 eller vecka 72 (för deltagare med genotyp 2/3) eller upp till vecka 72 (för deltagare med icke-genotyp 2/3)	Tid till första dosreduktion beräknades som tidsperioden från den första dosen till den första dosreduktionen.	Från baslinje upp till vecka 48 eller vecka 72 (för deltagare med genotyp 2/3) eller upp till vecka 72 (för deltagare med icke-genotyp 2/3)
Genomsnittlig förändring från baslinjen i systoliskt blodtryck (SBP) och diastoliskt blodtryck (DBP) vid de angivna tidpunkterna under DB-fasen Tidsram: DB Fas: Baseline; Vecka 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40 och 44; Slut på behandling (upp till vecka 48); 4-veckors uppföljning (FU) (upp till vecka 52); 12 veckors FU (upp till vecka 60); och 24-veckors FU (upp till vecka 72)	Deltagarens blodtryck mättes vid de angivna tidpunkterna under studien. Systoliskt blodtryck är ett mått på blodtrycket medan hjärtat slår. Diastoliskt blodtryck är ett mått på blodtrycket medan hjärtat är avslappnat. Genomsnittlig förändring från Baseline beräknades som värdet vid de angivna tidpunkterna minus värdet vid Baseline.	DB Fas: Baseline; Vecka 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40 och 44; Slut på behandling (upp till vecka 48); 4-veckors uppföljning (FU) (upp till vecka 52); 12 veckors FU (upp till vecka 60); och 24-veckors FU (upp till vecka 72)
Genomsnittlig förändring från baslinjen i hjärtfrekvens vid de angivna tidpunkterna under DB-fasen Tidsram: DB Fas: Baseline; Vecka 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40 och 44; Slut på behandling (upp till vecka 48); 4-veckors uppföljning (FU) (upp till vecka 52); 12 veckors FU (upp till vecka 60); och 24-veckors FU (upp till vecka 72)	Hjärtfrekvensen mättes hos deltagarna vid de angivna tidpunkterna. Genomsnittlig förändring från Baseline beräknades som värdet vid de angivna tidpunkterna minus värdet vid Baseline.	DB Fas: Baseline; Vecka 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40 och 44; Slut på behandling (upp till vecka 48); 4-veckors uppföljning (FU) (upp till vecka 52); 12 veckors FU (upp till vecka 60); och 24-veckors FU (upp till vecka 72)
Genomsnittlig förändring från baslinjen i vikt vid de angivna tidpunkterna under DB-fasen Tidsram: DB Fas: Baseline; Vecka 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40 och 44; Slut på behandling (upp till vecka 48); 4-veckors uppföljning (FU) (upp till vecka 52); 12 veckors FU (upp till vecka 60); och 24-veckors FU (upp till vecka 72)	Deltagarnas vikt registrerades vid de angivna tidpunkterna. Genomsnittlig förändring från Baseline beräknades som värdet vid de angivna tidpunkterna minus värdet vid Baseline.	DB Fas: Baseline; Vecka 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40 och 44; Slut på behandling (upp till vecka 48); 4-veckors uppföljning (FU) (upp till vecka 52); 12 veckors FU (upp till vecka 60); och 24-veckors FU (upp till vecka 72)
Genomsnittlig förändring från baslinjen i Body Mass Index (BMI) vid de angivna tidpunkterna under DB-fasen Tidsram: DB Fas: Baseline; Vecka 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40 och 44; Slut på behandling (upp till vecka 48); 4-veckors uppföljning (FU) (upp till vecka 52); 12 veckors FU (upp till vecka 60); och 24-veckors FU (upp till vecka 72)	BMI för deltagarna beräknades vid de angivna tidpunkterna som kroppsvikt i kilogram dividerat med höjd i meter i kvadrat. Genomsnittlig förändring från Baseline beräknades som värdet vid de angivna tidpunkterna minus värdet vid Baseline.	DB Fas: Baseline; Vecka 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40 och 44; Slut på behandling (upp till vecka 48); 4-veckors uppföljning (FU) (upp till vecka 52); 12 veckors FU (upp till vecka 60); och 24-veckors FU (upp till vecka 72)
Number of Participants Whose Platelet Count Increased From a Baseline Count of <75 Gi/L to a Count Greater Than or Equal to (>=) 90 Giga (10^9) Cells Per Liter (Gi/L) During the Open-label (OL) Pre-Antiviral Treatment Phase Tidsram: 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 >=90 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 Tidsram: 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 <90 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 <90 Gi/L. Participants who achieved platelet count >=90 Gi/L on 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 DB Phase Tidsram: 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.	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 During the DB Phase Tidsram: 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 Tidsram: From Baseline up to Week 12	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 12
Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) During the DB Phase Tidsram: From Baseline up to Week 12	EVR is defined as a clinically significant reduction from Baseline in HCV RNA (>=2 log10 decrease in HCV RNA or undetectable HCV RNA) after 12 weeks of antiviral treatment. cEVR, a subset of EVR, is defined exclusively as undetectable HCV RNA after 12 weeks of antiviral treatment.	From Baseline up to Week 12
Number of Participants With End of Treatment Response (ETR) and Sustained Virological Response at Week 12 of Follow-up (SVR12) During the DB Phase Tidsram: From Baseline up to Week 36 or Week 60 (for participants with Genotype 2/3) or up to Week 60 (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 36 or Week 60 (for participants with Genotype 2/3) or up to Week 60 (for participants with Non-Genotype 2/3)
Number of Participants in the Indicated Categories for Antiviral Therapy Dose Reductions in the DB Phase Tidsram: 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). Where possible, every effort was made to maintain the recommended dose of antiviral therapy for the treatment duration in the DB Phase. However, where 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)
Number of Participants With the Indicated Levels of Peginterferon Dose Reductions in the DB Phase Tidsram: 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 (mcg). For peginterferon dose modification, downward adjustments in one level increments was considered. The lowest dose of peginterferon alfa-2a that was allowed to be administered was 45 mcg. Where dose adjustment was required for moderate to severe adverse reactions (clinical and/or laboratory), an initial dose reduction to 135 mcg was generally adequate. In some cases, a dose reduction to 90 mcg or 45mcg 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 Tidsram: 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 from 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 (Par.) 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) During the DB Phase Tidsram: 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. Genotyping of the IL28B polymorphisms (rs12979860 and rs8099917) was conducted. IL28B genotype distribution by response to antiviral therapy (SVR and RVR) for both treatment arms 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 Par. 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) During the DB Phase Tidsram: 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 During the DB Phase Tidsram: 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 During the DB Phase Tidsram: 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 Tidsram: 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 investigator assigned an ECG status of normal, abnormal, CS, or NCS; a status of "abnormal" alone indicates that the investigator did not determine if ECG was CS or NCS. 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 Tidsram: 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 or a NCS change from baseline in ECG status was reported, as determined by the Investigator based on a reasonable standard 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)

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

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-2a Plus Ribavirin

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