A study to evaluate how different combinations of antiviral agents, when given with standard medicines, affect the treatment outcome of patients infected with the Hepatitis C Virus (HCV).

• Register: EUCTR
• Last refreshed on: 27 January 2014
• Main ID: EUCTR2011-000456-42-BG
• Date of registration: 16/01/2012
• Prospective Registration: Yes
• Primary sponsor: Gilead Sciences Inc.
• Public title: A study to evaluate how different combinations of antiviral agents, when given with standard medicines, affect the treatment outcome of patients infected with the Hepatitis C Virus (HCV).
• Scientific title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy with GS-5885 Alone or in Combination with GS-9451 with Peginterferon Alfa 2a and Ribavirin in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus Infection
• Date of first enrolment: 17/01/2012
• Target sample size: 300
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-000456-42
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Australia, Bulgaria, Czech Republic, France, Germany, Hungary, Italy, New Zealand, Poland, 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 from 18 to 70 years old
3. Chronic HCV infection
5. Monoinfection with HCV GT 1
6. HCV RNA > 10e4 IU/mL
7. HCV treatment naïve
8. Candidate for PEG/RBV therapy.
9. Body mass index (BMI) between 18 and 36 kg/m2
10. Subjects must have liver biopsy results (= 2 years prior to
Screening) indicating the absence of cirrhosis. Alternatively a
non-invasive procedure such as FibroTest, FibroScan, or
Acoustic Radiation Force Impulse imaging must have been
conducted within 6 months of Screening in countries where
allowed.
11.Agree to use two forms of highly effective contraception
methods for the duration of the study and for 7 months after the
last dose of study medication. Females of childbearing
potential must have negative pregnancy test at Screening and
Baseline.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 270
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion criteria:
1. Pregnant female or male with pregnant female partner
2. Poorly-controlled diabetes mellitus
3. History of clinically significant hemoglobinopathy
4. History of clinically significant retinal disease
5. History of invasive malignancy diagnosed or treated within 5 years
6. Untreated or significant psychiatric illnesses
7. Contraindications for PEG or RBV therapy
8. Co-infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
9. Chronic use of systemically administered immunosuppressive agents
10. Presence of autoimmune disorders
11. Severe chronic obstructive pulmonary disease
12. History of significant cardiac disease
13. Known cirrhosis
14. Chronic liver disease of a non-HCV etiology
15. History of solid organ transplantation
16. Suspicion of hepatocellular carcinoma
17. Current or prior history of clinical hepatic decompensation


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

Health Condition(s) or Problem(s) studied

Genotype 1 Hepatitis C Virus Infection
MedDRA version: 14.1 Level: SOC Classification code 10021881 Term: Infections and infestations System Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations

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

Intervention(s)

Product Name: GS-5885
Product Code: GS-5885
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: GS-5885
Other descriptive name: GS-5885
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-

Product Name: GS-9451
Product Code: GS-9451
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: GS-9451
Other descriptive name: GS-9451
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Trade Name: Copegus
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)

Main Objective: To evaluate the antiviral efficacy as measured by sustained virologic response (SVR, defined as plasma HCV RNA < LLoQ at 24 weeks post-treatment) of response guided therapy (RGT) with GS-5885 + GS-9451 + PEG/RBV or GS-5885 + PEG/RBV.

Timepoint(s) of evaluation of this end point: 24 weeks post treatment

Primary end point(s): Plasma HCV RNA

Secondary Objective: To evaluate the safety and tolerability of each regimen

To characterize viral dynamics and steady state pharmacokinetics of GS-5885 and
GS-9451 when administered with PEG and RBV

To characterize the viral resistance to GS-5885 and GS-9451 when administered in
combination with PEG and RBV

Secondary Outcome(s)

Secondary end point(s): vRVR, eRVR, pEVR, HCV RNA < LLoQ

Timepoint(s) of evaluation of this end point: Week 2, 4, 8, 12, 16, 20, 24, 36, 48 of treatment, and at Week 4, 12 and 24 post-treatment.

Secondary ID(s)

GS-US-256-0148

2011-000456-42-DE

Source(s) of Monetary Support

Gilead Sciences Inc.