Phase 3 Efficacy and Safety Study of Favipiravir for Treatment of Uncomplicated Influenza in Adults - T705US316

October 20, 2015 updated by: MDVI, LLC

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Favipiravir in Adult Subjects With Uncomplicated Influenza (T705US316)

The purpose of this study is to determine if favipiravir is effective in reducing the time to resolution of influenza symptoms.

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.

Detailed Description

The purpose of this study is to determine if a 5-day regimen of favipiravir reduces the time to alleviation of influenza symptoms, resolution of fever, and viral shedding, in subjects with uncomplicated influenza compared to no treatment (e.g. placebo).

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.
860

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
    • South Australia
      • Bedford Park, South Australia, Australia, 05042
  • Belgium
      • Deurne, Belgium, 2100
      • Gribomont, Belgium, 6887
      • Linkebeek, Belgium, 1630
    • Antwerpen
      • Deurne, Antwerpen, Belgium, 2100
    • Brussels
      • Bruxelles, Brussels, Belgium, 1080
    • Hainaut
      • Gozee, Hainaut, Belgium, 6534
      • Mont-sur-Marchienne, Hainaut, Belgium, 6032
    • Limburg
      • Halen, Limburg, Belgium, 3545
      • Ham, Limburg, Belgium, 3945
    • Liège
      • Chenée, Liège, Belgium, 4032
  • Bulgaria
      • Burgas, Bulgaria, 8000
      • Burgas, Bulgaria, 8112
      • Gabrovo, Bulgaria, 5300
      • Haskovo, Bulgaria, 6300
      • Plovdiv, Bulgaria, 4002
      • Plovdiv, Bulgaria, 4000
      • Ruse, Bulgaria, 7002
      • Ruse, Bulgaria, 7001
      • Samokov, Bulgaria, 2000
      • Sevlievo, Bulgaria, 5400
      • Sliven, Bulgaria, 8800
      • Smolyan, Bulgaria, 4700
      • Sofia, Bulgaria, 1431
      • Sofia, Bulgaria, 1000
      • Sofia, Bulgaria, 1303
      • Sofia, Bulgaria, 1463
      • Sofia, Bulgaria, 1505
      • Sofia, Bulgaria, 1618
      • Varna, Bulgaria, 9000
      • Varna, Bulgaria, 9020
      • Veliko Tarnovo, Bulgaria, 5000
    • Sofia-Grad
      • Sofia, Sofia-Grad, Bulgaria, 1000
  • Hungary
      • Balassagyarmat, Hungary, 2660
      • Budapest, Hungary, 1135
      • Csongrad, Hungary, 6640
      • Debrecen, Hungary, 4043
      • Gyula, Hungary, 5700
      • Gödöllő, Hungary, 2100
      • Nyiregyhaza, Hungary
      • Zalaegerszeg, Hungary, 8900
  • Netherlands
      • Den Haag, Netherlands, 2526 HW
      • Lieshout, Netherlands, 5737 CB
      • Nijverdal, Netherlands, 7442 LS
      • Rotterdam, Netherlands, 3039 BD
      • Zwijndrecht, Netherlands, 3334 CL
    • Overijssel
      • Nijverdal, Overijssel, Netherlands, 7442 LS
    • Overissel
      • Nijverdal, Overissel, Netherlands, 7442 LS
    • Zuid-Holland
      • Hoogvliet, Zuid-Holland, Netherlands, 3192 JN
  • New Zealand
      • Tauranga, New Zealand, 3143
    • North Island
      • Auckland, North Island, New Zealand, 0612
    • South Island
      • Christchurch, South Island, New Zealand
    • Waikato
      • Hamilton, Waikato, New Zealand, 3204
  • Poland
      • Katowice, Poland, 40-752
      • Katowice, Poland, 40-211
      • Krakow, Poland, 31-011
      • Kraków, Poland, 31-637
      • Lódz, Poland, 93-328
      • Ostroda, Poland, 14-100
      • Oswiecim, Poland, 32-600
    • Dolnoslaskie
      • Olesnica, Dolnoslaskie, Poland, 56-400
      • Wroclaw, Dolnoslaskie, Poland, 53-301
      • Wroclaw, Dolnoslaskie, Poland, 54-144
    • Kujawsko-pomorskie
      • Torun, Kujawsko-pomorskie, Poland, 87-100
    • Lubelskie
      • Swidnik, Lubelskie, Poland, 21-040
    • Lódzkie
      • Lodz, Lódzkie, Poland, 91-463
      • Zgierz, Lódzkie, Poland, 95-100
    • Malopolskie
      • Tarnów, Malopolskie, Poland, 33-100
    • Mazowieckie
      • Losice, Mazowieckie, Poland, 08-200
    • Podkarpackie
      • Debica, Podkarpackie, Poland, 39-200
      • Rzeszow, Podkarpackie, Poland, 35-055
    • Slaskie
      • Katowice, Slaskie, Poland, 40-211
      • Katowice, Slaskie, Poland, 40-772
  • Russian Federation
      • Arkangelsk, Russian Federation, 163000
      • Kazan, Russian Federation, 420012
      • Moscow, Russian Federation, 129090
      • Novosibirsk, Russian Federation, 630051
      • Novosibirsk, Russian Federation, 630099
      • Ryazan, Russian Federation, 390005
      • Saratov, Russian Federation, 410028
      • St. Petersburg, Russian Federation
      • St. Petersburg, Russian Federation, 196247
      • St. Petersburg, Russian Federation, 194044
      • St. Petersburg, Russian Federation, 198328
      • Tomsk, Russian Federation, 634050
      • Vladimir, Russian Federation, 600023
      • Yaroslavl, Russian Federation, 150007
  • South Africa
      • Cape Town, South Africa, 7572
      • Durban, South Africa, 4068
      • Johannesburg, South Africa, 2113
      • Krugersdorp, South Africa, 1724
      • Potchefstroom, South Africa, 2531
      • Pretoria, South Africa, 0001
      • Sophiatown, Johannesburg, South Africa, 2129
      • Umkomaas, South Africa, 4170
      • Welkom, South Africa, 9459
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
    • Gauteng
      • Bryanston, Gauteng, South Africa, 2021
      • Johannesburg, Gauteng, South Africa, 1619
      • Johannesburg, Gauteng, South Africa, 1818
      • Johannesburg, Gauteng, South Africa, 2113
      • Pretoria, Gauteng, South Africa, 0084
      • Pretoria, Gauteng, South Africa, 0081
      • Pretoria, Gauteng, South Africa, 0140
      • Pretoria, Gauteng, South Africa, 1501
      • Sophiatown, Johannesburg, Gauteng, South Africa, 2129
      • Soweto, Gauteng, South Africa, 1818
    • Kwazulu - Natal
      • Amanzimtoti, Kwazulu - Natal, South Africa, 4126
      • Dundee, Kwazulu - Natal, South Africa, 3000
    • Mpumalanga
      • Middelburg, Mpumalanga, South Africa, 1050
      • Witbank, Mpumalanga, South Africa, 1035
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7130
      • Cape Town, Western Cape, South Africa, 7965
      • Cape Town, Western Cape, South Africa, 8002
      • Paarl, Western Cape, South Africa, 7646
      • Worcester, Western Cape, South Africa, 6850
  • Spain
      • Alicante, Spain, 03610
      • Barcelona, Spain, 08907
      • Barcelona, Spain, 08041
      • Barcelona, Spain, 08028
      • Tarragona, Spain, 43007
    • Alicante
      • Benidorm, Alicante, Spain, 03500
      • Orihuela, Alicante, Spain, 03300
    • Barcelona
      • Badalona, Barcelona, Spain, 08917
    • Castellón
      • Castellon de la Plana, Castellón, Spain, 12005
    • Cataluña
      • Barcelona, Cataluña, Spain, 08036
    • Girona
      • Llanca, Girona, Spain, 17490
  • Sweden
      • Karlskrona, Sweden, SE-37141
      • Linköping, Sweden, SE-58216
      • Malmö, Sweden, SE-20502
      • Uppsala, Sweden, SE-75185
    • Skane lan
      • Malmö, Skane lan, Sweden, SE-21152
    • Sodermanlands lan
      • Stockholm, Sodermanlands lan, Sweden, SE-11157
      • Stockholm, Sodermanlands lan, Sweden, SE-11522
    • Uppsala Ian
      • Uppsala, Uppsala Ian, Sweden, SE-75185
    • Vastra Gotalands lan
      • Göteborg, Vastra Gotalands lan, Sweden, SE-41345
  • Turkey
      • Ankara, Turkey, 06100
      • Diyarbakir, Turkey, 21280
      • Duzce, Turkey, 81600
      • Erzurum, Turkey, 25240
      • Eskisehir, Turkey, 26480
      • Izmir, Turkey, 35100
      • Izmir, Turkey, 35210
      • Konya, Turkey, 42075
      • Samsun, Turkey, 55139
      • Trabzon, Turkey, 61080
  • Ukraine
      • Kharkiv, Ukraine, 61052
      • Kherson, Ukraine, 73013
      • Kyiv, Ukraine, 01601
      • Kyiv, Ukraine, 02232
      • Kyiv, Ukraine, 04050
      • Poltava, Ukraine, 36000
      • Sumy, Ukraine, 40015
    • Chernivets'ka Oblast
      • Chernivtsi, Chernivets'ka Oblast, Ukraine, 58005
    • Ivano-Frankivs'ka Oblast
      • Ivano-Frankivsk, Ivano-Frankivs'ka Oblast, Ukraine, 76018
    • Kharkivs'ka Oblast
      • Kharkiv, Kharkivs'ka Oblast, Ukraine, 61007
    • Kyïv
      • Kyiv, Kyïv, Ukraine, 04050
    • Kyïvs'ka Oblast
      • Kyiv, Kyïvs'ka Oblast, Ukraine, 02002
    • Odes'ka Oblast
      • Odesa, Odes'ka Oblast, Ukraine, 65023
      • Odesa, Odes'ka Oblast, Ukraine, 65114
    • Ternopil's'ka Oblast
      • Ternopil, Ternopil's'ka Oblast, Ukraine, 46008
    • Vinnyts'ka Oblast
      • Vinnytsya, Vinnyts'ka Oblast, Ukraine, 21029
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
      • Birmingham, Alabama, United States, 06117
      • Hunstville, Alabama, United States, 35801
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
    • California
      • Los Angeles, California, United States, 90017
      • Los Angeles, California, United States, 90020
      • Orange, California, United States, 92866
      • Sacramento, California, United States, 95825
      • San Diego, California, United States, 92120
      • San Diego, California, United States, 92128
      • Tustin, California, United States, 92780
      • Upland, California, United States, 91786
    • Colorado
      • Colorado Springs, Colorado, United States, 80904
    • Connecticut
      • Hamden, Connecticut, United States, 65140
    • Florida
      • Bradenton, Florida, United States, 34205
      • Brooksville, Florida, United States, 34601
      • Gainesville, Florida, United States, 32607
      • Gainesville, Florida, United States, 32605
      • Hialeah, Florida, United States, 33016
      • Hialeah, Florida, United States, 33012
      • Lakeland Hills, Florida, United States, 33805
      • Miami, Florida, United States, 33173
      • Miami, Florida, United States, 33137
      • Miami, Florida, United States, 33126
      • Miami, Florida, United States, 33135
      • Saint Cloud, Florida, United States, 34769
      • Saint Petersburg, Florida, United States, 33709
      • South Miami, Florida, United States, 33143
      • Tampa, Florida, United States, 33606
    • Georgia
      • Atlanta, Georgia, United States, 30312
      • Snellville, Georgia, United States, 30039
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
    • Louisiana
      • Monroe, Louisiana, United States, 71201
      • Opelousas, Louisiana, United States, 70570
    • Michigan
      • Flint, Michigan, United States, 48504
    • Nebraska
      • Omaha, Nebraska, United States, 68114
    • Nevada
      • Las Vegas, Nevada, United States, 89121
    • North Carolina
      • Hickory, North Carolina, United States, 28601
      • Morganton, North Carolina, United States, 28655
      • Winston Salem, North Carolina, United States, 27103
    • Pennsylvania
      • Lansdale, Pennsylvania, United States, 19446
      • Pittsburgh, Pennsylvania, United States, 15236
      • Smithfield, Pennsylvania, United States, 15478
      • Uniontown, Pennsylvania, United States, 15401
    • South Carolina
      • Gaffney, South Carolina, United States, 29341
      • Greenville, South Carolina, United States, 29615
      • Greer, South Carolina, United States, 29651
      • Simpsonville, South Carolina, United States, 29681
    • Texas
      • Arlington, Texas, United States, 76012
      • Austin, Texas, United States, 78756
      • Carrollton, Texas, United States, 75010
      • Forth Worth, Texas, United States, 76104
      • Houston, Texas, United States, 77062
      • Plano, Texas, United States, 75093
      • San Antonio, Texas, United States, 78207
    • Utah
      • Salt Lake City, Utah, United States, 84121
      • Salt Lake City, Utah, United States, 84109
      • South Jordan, Utah, United States, 84095
    • Virginia
      • Arlington, Virginia, United States, 22203
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At time of enrollment has 2 or more of the following symptoms (moderate to severe in intensity) that began 48 hours or less prior to the anticipated start of dosing with study medication: cough, sore throat, headache, nasal congestion, body aches and pains, fatigue
  • Has a fever at the first visit or in the 6 hours prior if antipyretics were taken, defined as: ≥ 38.0°C (≥ 100.4°F) if < 65 years old; or ≥ 37.8°C (≥ 100.0°F) if ≥ 65 years old
  • Tests positive for influenza A or B during the 48 hours between onset of symptoms and anticipated dosing with study medication as confirmed by RAT or PCR testing (study or non-study procedure); or per Investigator and Medical Monitor discretion in the event there is a known influenza outbreak circulating in the community or the subject has been in close contact with a person who was recently confirmed to have laboratory-confirmed influenza
  • Willing to adhere to strict contraceptive measures throughout study and for 3 months following last dose of study medication

Exclusion Criteria:

  • Female subjects who are pregnant, currently breast-feeding, or have a positive pregnancy test at Screening
  • Has taken an anti-influenza drug, or received any live attenuated influenza vaccine within 4 weeks prior to signing the informed consent
  • Has underlying chronic respiratory disease; includes bronchial asthma if currently experience asthma symptoms, requires current asthma treatment, or has had an asthma attack in the past year
  • Is suspected of having bacterial respiratory infection (i.e., expectoration of purulent or mucopurulent sputum and/or infiltrate in lung observed on chest x ray, or is on antibiotics for pulmonary disease) at start of study
  • Has a history of gout or is under treatment for: gout or hyperuricemia; hereditary xanthinuria; hypouricemia or xanthine calculi of the urinary tract
  • Has a history of hypersensitivity to an anti-viral nucleoside-analog drug targeting a viral RNA polymerase
  • Current use of adrenocorticosteroids (except topical preparation) or immunosuppressive drugs
  • Has an allergy or contraindication to use of acetaminophen (paracetamol)
  • Has a serious chronic disease, history of alcohol or drug abuse within preceding 2 years, psychiatric illness not well controlled (not on stable regimen > 1 year), or is deemed by the Investigator to be ineligible for any reason
  • Previously participated in a clinical trial of favipiravir (T-705)
  • Has renal insufficiency requiring hemodialysis or continuous ambulatory peritoneal dialysis (CAPD)

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: Quadruple

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.
Placebo Comparator: placebo
Drug: Placebo
Administered twice daily over 5 consecutive days for a total of 10 doses.
Active Comparator: favipiravir
Drug: favipiravir

Administered twice daily over 5 consecutive days for a total of 10 doses.

  • Day 1: 1800 mg twice daily (loading doses)
  • Days 2 through 5: 800 mg twice daily
Other Names:
  • T-705

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
Time to alleviation of all primary influenza symptoms and fever
Time Frame: 21 days
Time from the start of study treatment until alleviation of all primary influenza symptoms (i.e. cough, sore throat, headache, nasal congestion, body aches and pains, fatigue) and to resolution of fever. Subjects will be considered to have symptoms alleviated if individual symptoms are no greater than mild and are confirmed to be no greater than mild at least 21.5 hours later. Similarly, resolution of fever is defined as temperature (oral) measurements to be < 38.0°C (<100.4°F) for subjects < 65 years old and < 37.8°C (100.0°F) for subjects ≥ 65 years old, and measurements are confirmed at least 21.5 hours later. For the primary endpoint, the time periods of alleviation/fever resolution must be concurrent for symptoms and temperature.
21 days

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
Time to alleviation each of the primary influenza symptoms and fever
Time Frame: 21 days
Time from the start of study treatment until alleviation of each of the following influenza symptoms (cough, sore throat, headache, nasal congestion, body aches and pains, and fatigue) and to resolution of fever. Subjects will be considered to have symptoms alleviated if individual symptoms are no greater than mild and are confirmed to be no greater than mild at least 21.5 hours later. Similarly, resolution of fever is defined as temperature (oral) measurements to be < 38.0°C (<100.4°F) for subjects < 65 years old and < 37.8°C (100.0°F) for subjects ≥ 65 years old, and measurements are confirmed at least 21.5 hours later. Additional analyses of symptoms, including assessment of the impact of relevant covariates, will be specified in the Statistical Analysis Plan.
21 days
To characterize the PK of favipiravir when used under clinical conditions
Time Frame: 21 days
Population PK analysis of favipiravir with assessment of maximum plasma concentration (Cmax), minimum plasma concentration (Cmin), and total daily exposure AUC(0-24h) on Visits 1, 2, 3, 4 and 5
21 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in viral load
Time Frame: 15 days
Changes in viral load (nasopharyngeal swabs) as measured by quantitative polymerase chain reaction (qPCR) and in the determination of median tissue culture infective dose (TCID50), from nasopharyngeal swabs at Visits 2, 3, 4, and 5; and log-transformed viral load (by qPCR and TCID50) area under the curves (AUCs).
15 days
Safety
Time Frame: 21 days
Adverse events and clinical laboratory tests for systemic safety including hematology, clinical chemistry, and urinalysis
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MDVI, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
MediVector, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Carol Epstein, MD, MediVector, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 3, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 11, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • T705US316
  • 2013-002149-13 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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