Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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30 June 2019 |
Main ID: |
EUCTR2012-000571-16-GB |
Date of registration:
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11/09/2012 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A study with GS-7977 + Ribavirin with or without Peginterferon Alfa-2a for patients with chronic Hepatitis C infection who previously took part in Gilead-sponsored studies for Hepatitis C.
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Scientific title:
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An Open-Label Study of GS-7977 + Ribavirin with or without Peginterferon Alfa-2a in Subjects with Chronic HCV Infection who Participated in Prior Gilead HCV Studies. |
Date of first enrolment:
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09/11/2012 |
Target sample size:
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600 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-000571-16 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 3
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Australia
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Austria
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Czech Republic
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Estonia
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France
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Germany
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Italy
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Netherlands
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New Zealand
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Poland
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Spain
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Sweden
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United Kingdom
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United States
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Contacts
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Name:
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Medical Monitor
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Address:
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333 Lakeside Drive
CA 94404
Foster City
United States |
Telephone:
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+1650574 3000 |
Email:
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clinical.trials@gilead.com |
Affiliation:
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Gilead Sciences Inc. |
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Name:
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Medical Monitor
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Address:
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333 Lakeside Drive
CA 94404
Foster City
United States |
Telephone:
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+1650574 3000 |
Email:
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clinical.trials@gilead.com |
Affiliation:
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Gilead Sciences Inc. |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Willing and able to provide written informed consent
2. Chronic HCV
3. Subject must have participated in a prior Gilead HCV study
4. HCV RNA >LLOQ
5. Screening ECG without clinically significant abnormalities
6. Subjects must have a number of laboratory parameters within defined ranges at screening
7. A female subject is eligible to enter the study if it is confirmed that she is:
a) Not pregnant or nursing
b) Of non-childbearing potential
c) Of childbearing potential but with a negative serum pregnancy test at screening and a negative urine pregnancy test on the Baseline/Day 1 visit prior to randomization and agree to one of the described forms of contraception during the course of the study and up to 7 months following cessation of Ribavirin therapy.
8. All male study participants must agree to consistently and correctly use a condom while their female partner agrees to use 1 of the methods of birth control listed in the protocol from the date of screening until 7 months after their last dose of RBV.
9. Male subjects must agree to refrain from sperm donation for at least 7 months after the last dose of RBV.
10. Subject must be of generally good health as determined by the Investigator.
11. Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 540 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria: 1. Pregnant or nursing female or male with pregnant female partner
2. Current or prior history of clinical hepatic decompensation (e.g., ascites, jaundice, encephalopathy or variceal hemorrhage).
3. Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
4. Chronic use of systemically administered immunosuppressive agents (e.g., prednisone equivalent > 10 mg/day)
5. Active substance abuse which, in the opinion of the investigator, would make the candidate inappropriate for participation in this study.
6. Use of any prohibited concomitant medications as described in the protocol within 28 days of the Baseline/Day 1 visit
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Chronic HCV Infection
MedDRA version: 14.1
Level: PT
Classification code 10019744
Term: Hepatitis C
System Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1
Level: PT
Classification code 10008912
Term: Chronic hepatitis C
System Organ Class: 10021881 - Infections and infestations
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Therapeutic area: Diseases [C] - Virus Diseases [C02]
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Intervention(s)
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Product Name: Sofosbuvir Product Code: GS-7977 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Sofosbuvir CAS Number: 1190307-88-0 Current Sponsor code: GS-7977 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400-
Trade Name: Ribasphere Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Ribavirin CAS Number: 36791-04-5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200-
Trade Name: Pegasys Pharmaceutical Form: Solution for injection INN or Proposed INN: PEGINTERFERON ALFA-2A CAS Number: 198153-51-4 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 180-
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: Efficacy endpoint: 12 weeks after cessation of therapy. Safety endpoint: throughout the duration of therapy.
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Main Objective: The primary objectives of this study are: • To determine the efficacy of GS-7977 + RBV with or without PEG as measured by the proportion of subjects with sustained viral response at 12 weeks after discontinuation of therapy (SVR12). • To evaluate the safety and tolerability of GS-7977 + RBV with or without PEG as assessed by review of the accumulated safety data.
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Primary end point(s): The primary efficacy endpoint is SVR12 (HCV RNA The primary safety endpoint is any AE leading to permanent discontinuation of study drug(s).
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Secondary Objective: The secondary objectives of this study are: • To determine the proportion of subjects who attain SVR at 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24) • To evaluate the kinetics of circulating HCV RNA during and after treatment discontinuation • To evaluate the emergence of viral resistance to GS-7977 during and after treatment discontinuation
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Secondary Outcome(s)
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Secondary end point(s): Secondary efficacy endpoints include the proportion of subjects with: HCV RNA < LLOQ at 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24); on treatment virologic failure; and relapse.
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Timepoint(s) of evaluation of this end point: 4 and 24 weeks after the cessation of therapy.
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Secondary ID(s)
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GS-US-334-0109
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2012-000571-16-AT
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Source(s) of Monetary Support
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Gilead Sciences Inc.
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Ethics review
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Status: Approved
Approval date:
Contact:
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