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.

• Register: EUCTR
• Last refreshed on: 28 September 2015
• Main ID: EUCTR2012-000571-16-SE
• Date of registration: 12/09/2012
• Prospective Registration: Yes
• Primary sponsor: Gilead Sciences Inc.
• Public title: 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.
• Scientific title: 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: 26/09/2012
• Target sample size: 600
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-000571-16
• Study type: Interventional clinical trial of medicinal product
• Study design: 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

Countries of recruitment

Australia, Austria, Czech Republic, Estonia, Germany, Italy, Netherlands, New Zealand, Poland, Spain, Sweden, United Kingdom, United States

Contacts

• Name: Medical Monitor
• Affiliation: Gilead Sciences Inc.

• Name: Medical Monitor
• Affiliation: Gilead Sciences Inc.

Key inclusion & exclusion criteria

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) no
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 Section 5.6 within 28 days of the Baseline/Day 1 visit


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Intervention(s)

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-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Efficacy endpoint: 12 weeks after cessation of therapy.
Safety endpoint: throughout the duration of therapy.

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).

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

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.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 4 and 24 weeks after the cessation of therapy.

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.

Secondary ID(s)

GS-US-334-0109

2012-000571-16-AT

Source(s) of Monetary Support

Gilead Sciences Inc.