A study looking at 12 weeks treatment with GS-7977 + Ribavirin for patients with chronic genotype 2 or 3 Hepatitis C infection who previously took part in Gilead-sponsored GS-7977 studies in the control arms.

• Register: EUCTR
• Last refreshed on: 8 December 2014
• Main ID: EUCTR2012-000571-16-NL
• Date of registration: 18/09/2012
• Prospective Registration: Yes
• Primary sponsor: Gilead Sciences Inc.
• Public title: A study looking at 12 weeks treatment with GS-7977 + Ribavirin for patients with chronic genotype 2 or 3 Hepatitis C infection who previously took part in Gilead-sponsored GS-7977 studies in the control arms.
• Scientific title: An Open-Label Study of GS-7977+ Ribavirin for 12 Weeks in Subjects with Chronic HCV Infection who Participated in Prior Studies Evaluating GS-7977.
• Date of first enrolment: 04/12/2012
• Target sample size: 200
• 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

Countries of recruitment

Australia, Austria, Czech Republic, Estonia, France, 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. HCV Genotype 2 or 3
3. Subject must have participated in a prior study of GS-7977 (PSI-7977)
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 180
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 20

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

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

Chronic Genotype 2 or 3 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: LLT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations

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-

Primary Outcome(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

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

Main Objective: The primary objectives of this study are:
• To determine the efficacy of GS-7977 + RBV 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 as assessed by review of the accumulated safety data.

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 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); viral breakthrough; and relapse.

Secondary ID(s)

GS-US-334-0109

2012-000571-16-AT

Source(s) of Monetary Support

Gilead Sciences Inc.