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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01542788




Registration number
NCT01542788
Ethics application status
Date submitted
17/02/2012
Date registered
2/03/2012
Date last updated
19/05/2014

Titles & IDs
Public title
Sofosbuvir + Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 Hepatitis C Infection Who Are Interferon Intolerant, Interferon Ineligible or Unwilling to Take Interferon
Scientific title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GS-7977 + Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 HCV Infection Who Are Interferon Intolerant, Interferon Ineligible or Unwilling to Take Interferon
Secondary ID [1] 0 0
GS-US-334-0107
Universal Trial Number (UTN)
Trial acronym
POSITRON
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis C 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 - SOF
Treatment: Drugs - RBV
Treatment: Drugs - Placebo to match SOF
Treatment: Drugs - Placebo to match RBV

Experimental: SOF+RBV - Participants were randomized to receive SOF+RBV for 12 weeks.

Placebo Comparator: Placebo - Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks.


Treatment: Drugs: SOF
Sofosbuvir (SOF) 400 mg tablet administered orally once daily

Treatment: Drugs: RBV
Ribavirin (RBV) was administered as a tablet orally according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and = 75 kg = 1200 mg).

Treatment: Drugs: Placebo to match SOF
Placebo to match SOF was administered orally once daily.

Treatment: Drugs: Placebo to match RBV
Placebo to match RBV was administered orally twice daily.

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

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving SVR12 - SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks after cessation of therapy
Timepoint [1] 0 0
Post-treatment Week 12
Primary outcome [2] 0 0
Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug - The number of subjects experiencing adverse events leading to permanent discontinuation of study drug was summarized. Adverse events may or may not have been related to study treatment.
Timepoint [2] 0 0
Baseline to Week 12
Secondary outcome [1] 0 0
Percentage of Participants Achieving SVR4 - SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy
Timepoint [1] 0 0
Post-treatment Week 4
Secondary outcome [2] 0 0
Percentage of Participants Achieving SVR24 - SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy
Timepoint [2] 0 0
Post-treatment Week 24
Secondary outcome [3] 0 0
Percentage of Participants Experiencing Viral Breakthrough - Viral breakthrough was defined as HCV RNA = LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values
Timepoint [3] 0 0
Baseline to Week 12
Secondary outcome [4] 0 0
Percentage of Participants Experiencing Viral Relapse - Viral relapse was defined as HCV RNA = LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement
Timepoint [4] 0 0
End of treatment to post-treatment Week 24

Eligibility
Key inclusion criteria
- Infection with HCV genotype 2 or 3

- Cirrhosis determination

- Subject meets one of the following classifications:

1. IFN unwilling

2. IFN ineligible

3. IFN intolerant

- Screening laboratory values within defined thresholds

- Subject has not been treated with any investigational drug or device within 30 days of
the Screening visit

- Use of highly effective contraception methods if female of childbearing potential or
sexually active male
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior exposure to an direct-acting antiviral targeting the HCV nonstructural protein
(NS)5B polymerase

- Pregnant or nursing female or male with pregnant female partner

- Current or prior history of clinical hepatic decompensation

- History of clinically-significant illness or any other major medical disorder that may
interfere with subject treatment, assessment or compliance with the protocol

- Excessive alcohol ingestion or significant drug abuse

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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
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)
NSW,QLD
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead,
Recruitment hospital [2] 0 0
Royal Brisbane & Women's Hospital - Herston
Recruitment hospital [3] 0 0
St. Vincent's Hospital - Melbourne
Recruitment hospital [4] 0 0
Monash Medical Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2145 - Westmead,
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
3065 - Melbourne
Recruitment postcode(s) [4] 0 0
3168 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
Rhode Island
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Virginia
Country [23] 0 0
United States of America
State/province [23] 0 0
Washington
Country [24] 0 0
Canada
State/province [24] 0 0
Alberta
Country [25] 0 0
Canada
State/province [25] 0 0
British Columbia
Country [26] 0 0
Canada
State/province [26] 0 0
Ontario
Country [27] 0 0
Canada
State/province [27] 0 0
Quebec
Country [28] 0 0
New Zealand
State/province [28] 0 0
Auckland
Country [29] 0 0
New Zealand
State/province [29] 0 0
Christchurch
Country [30] 0 0
Puerto Rico
State/province [30] 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 multicenter study was to evaluate subjects with chronic genotype 2 or 3 HCV infection
who were interferon (IFN) ineligible, IFN intolerant or unwilling to take IFN. Participants
were randomized in a 3:1 ratio to receive sofosbuvir (SOF)+ribavirin (RBV), or placebo to
match SOF+placebo to match RBV. Randomization was stratified by presence/absence of
cirrhosis. Approximately 20% of participants may have had evidence of cirrhosis at screening.
Trial website
https://clinicaltrials.gov/show/NCT01542788
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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