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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01356160




Registration number
NCT01356160
Ethics application status
Date submitted
2/05/2011
Date registered
19/05/2011
Date last updated
3/02/2014

Titles & IDs
Public title
GS-5885 Alone or in Combination With GS-9451 With Peginterferon Alfa 2a and Ribavirin in Treatment Chronic Genotype 1 Hepatitis C Virus
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
Secondary ID [1] 0 0
GS-US-256-0148
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C, Chronic 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GS-5885
Treatment: Drugs - GS-9451
Other interventions - peginterferon alfa-2a
Treatment: Drugs - ribavirin tablet
Treatment: Drugs - GS-9451 Placebo

Active Comparator: Arm 1 - RGT with GS-5885 30 mg QD + GS-9451 200 mg QD + PEG/RBV

Placebo Comparator: Arm 2 - RGT with GS-5885 30 mg QD + GS-9451 placebo QD + PEG/RBV


Treatment: Drugs: GS-5885
tablet, 30 mg QD

Treatment: Drugs: GS-9451
tablet, 200 mg QD

Other interventions: peginterferon alfa-2a
(solution for injection) 180 µg/week

Treatment: Drugs: ribavirin tablet
ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day = 75 kg) divided twice daily (BID)

Treatment: Drugs: GS-9451 Placebo
Placebo to match GS-9451 QD

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the antiviral efficacy of response guided therapy. - To evaluate the antiviral efficacy as measured by sustained virologic response (SVR, defined as plasma HCV RNA < Lower Limit of Quantification (LLoQ) at 24 weeks post-treatment) of response guided therapy (RGT) with GS-5885 + GS-9451 + PEG/RBV, or GS-5885 + PEG/RBV.
Timepoint [1] 0 0
Through 24 weeks post-treatment
Secondary outcome [1] 0 0
To evaluate the safety and tolerability of each regimen. - The primary safety endpoint is any AE leading to permanent discontinuation of study drugs.
Timepoint [1] 0 0
Through 24 weeks post-treatment
Secondary outcome [2] 0 0
To characterize viral dynamics of GS-5885 and GS-9451 when administered with PEG and RBV. - HCV RNA levels, pharmacokinetics and viral sequencing
Timepoint [2] 0 0
Through Day 10 on study
Secondary outcome [3] 0 0
To characterize the viral resistance to GS-5885 and GS-9451 when administered in combination with PEG and RBV. - Plasma samples will be collected and stored at each visit for possible resistance analysis.
Timepoint [3] 0 0
12 or 24 weeks
Secondary outcome [4] 0 0
To characterize steady state pharmacokinetics of GS-5885 and GS-9451 when administered with PEG and RBV. - Plasma concentrations of the study drug over time will be summarized using descriptive statistics.
Timepoint [4] 0 0
Through 48 weeks of treatment

Eligibility
Key inclusion criteria
- Males and females 18-70 years of age

- Chronic HCV infection

- Subjects must have liver biopsy results (= 2 years prior to Screening) indicating the
absence of cirrhosis.

- Monoinfection with HCV genotype 1

- HCV RNA > 10^4 IU/mL at Screening

- HCV treatment naïve

- Candidate for PEG/RBV therapy

- Body mass index (BMI) 18-36 kg/m2, inclusive

- 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.
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnant female or male with pregnant female partner

- Exceed defined thresholds for leukopenia, neutropenia, anemia, thrombocytopenia,
thyroid stimulating hormone (TSH)

- Diagnosis of autoimmune disease, decompensated liver disease, poorly controlled
diabetes mellitus, significant psychiatric illness, severe chronic obstructive
pulmonary disease (COPD), HIV, hepatitis B virus (HBV), hepatocellular carcinoma or
other malignancy (with exception of certain resolved skin cancers), hemoglobinopathy,
retinal disease, or are immunosuppressed.

- Subjects with current use of amphetamines, cocaine, opiates (e.g., morphine, heroin),
or ongoing alcohol abuse are excluded. Patients on stable methadone or buprenorphine
maintenance treatment for at least 6 months prior to Screening may be included into
the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
- Herston
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Virginia
Country [14] 0 0
Puerto Rico
State/province [14] 0 0
San Juan

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is 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.
Trial website
https://clinicaltrials.gov/show/NCT01356160
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bittoo Kanwar, MD
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications