A study comparing 3 different treatments and treatment durations for hepatitis C

• Register: EUCTR
• Last refreshed on: 3 April 2017
• Main ID: EUCTR2013-002641-11-GB
• Date of registration: 08/08/2013
• Prospective Registration: Yes
• Primary sponsor: Gilead Sciences Inc.
• Public title: A study comparing 3 different treatments and treatment durations for hepatitis C
• Scientific title: A Phase 3B Randomized, Open-Label, Multi-Center Trial Assessing Sofosbuvir + Ribavirin for 16 or 24 Weeks and Sofosbuvir + Pegylated Interferon + Ribavirin for 12 Weeks in Subjects with Genotype 2 or 3 Chronic HCV Infection
• Date of first enrolment: 07/10/2013
• Target sample size: 600
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-002641-11
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Each arm is a treatment regimen being compared to the other 2 arms Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Canada, New Zealand, 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) Male or female, aged 18 years or older
3) Chronic HCV infection
4) Willing to undergo liver biopsy, if required
5) Genotype 2 subjects must have cirrhosis of the liver to be eligible
6) Treatment-naïve or prior treatment failure to =12 weeks of an interferon-based regimen that was not discontinued prematurely due to an adverse event
7) Infection with HCV genotype 2 or 3
10) A negative serum pregnancy test is required for female subjects (unless surgically sterile or greater than two years post-menopausal). Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception. Lactating females must agree to discontinue nursing before the IMP is administered.
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) Prior exposure to an direct-acting antiviral targeting the HCV NS5B polymerase
2) Pregnant or nursing female or male with pregnant female partner
3) Chronic liver disease of a non-HCV etiology
4) Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
5) Significant psychiatric conditions
6) Autoimmune disease
7) Severe chronic pulmonary obstructive disease
8) History of significant cardiac disease including prior myocardial infarction or arrhythmia


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

Health Condition(s) or Problem(s) studied

Hepatitis C Virus 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
Other descriptive name: GS-7977
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-

Trade Name: Ribasphere
Product Name: Ribavirin
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
Product Name: Pegylated interferon alfa
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: 12 Weeks after last dose of study drug

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 treatment (SVR4 and SVR24)
- To evaluate the kinetics of circulating HCV RNA during and after treatment discontinuation
- To evaluate the emergence of viral resistance to SOF during and after treatment discontinuation

Main Objective: The primary objectives of this study are:
- To determine the efficacy of sofosbuvir (SOF)+ Ribavirin (RBV) for 16 or 24 weeks as measured by the proportion of subjects with sustained viral response 12 weeks after discontinuation of treatment (SVR12)
- To determine the efficacy of SOF+RBV+pegylated interferon alfa 2a (PEG) for 12 weeks as measured by the proportion of subjects with SVR12
- To evaluate the safety and tolerability of all 3 treatment arms 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: During treatment and 4 and 24 weeks after last dose of study drug

Secondary end point(s): Secondary efficacy endpoints include the proportion of subjects with HCV RNA < LLOQ at each on-treatment visit and 4 and 24 weeks after discontinuation of active therapy (SVR4 and SVR24); HCV RNA (log10 IU/mL) and change from baseline in HCV RNA (log10 IU/mL); viral breakthrough; and relapse.

Secondary ID(s)

GS-US-334-0153

Source(s) of Monetary Support

Gilead Sciences Inc.