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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01625338




Registration number
NCT01625338
Ethics application status
Date submitted
7/06/2012
Date registered
21/06/2012
Date last updated
9/11/2015

Titles & IDs
Public title
Open-Label Study of Sofusbuvir+Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies
Scientific title
An Open-Label Study of GS-7977 + Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies
Secondary ID [1] 0 0
2012-000571-16
Secondary ID [2] 0 0
GS-US-334-0109
Universal Trial Number (UTN)
Trial acronym
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 - Peg-IFN

Experimental: SOF+RBV 12 Weeks - SOF+RBV for 12 weeks

Experimental: SOF+RBV 24 Weeks - SOF+RBV for 24 weeks

Experimental: SOF+RBV+Peg-IFN 12 Weeks - SOF+RBV+Peg-IFN for 12 weeks


Treatment: Drugs: SOF
SOF 400 mg tablet administered orally once daily

Treatment: Drugs: RBV
RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and = 75 kg = 1200 mg)

Treatment: Drugs: Peg-IFN
Peg-IFN 180 µg administered once weekly by subcutaneous injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
Timepoint [1] 0 0
Posttreatment Week 12
Primary outcome [2] 0 0
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Timepoint [2] 0 0
Up to 24 weeks
Secondary outcome [1] 0 0
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Timepoint [1] 0 0
Posttreatment Weeks 4 and 24
Secondary outcome [2] 0 0
Percentage of Participants With On-treatment Virologic Failure
Timepoint [2] 0 0
Up to 24 weeks
Secondary outcome [3] 0 0
Percentage of Participants With Viral Relapse
Timepoint [3] 0 0
Up to Posttreatment Week 24

Eligibility
Key inclusion criteria
- Infection with HCV

- Must have participated in a prior Gilead HCV study

- Use of highly effective contraception methods if female of childbearing potential or
sexually active male

- Eligible patients include those in the following

- received placebo or Peg-IFN+RBV in a control arm

- previously participated in a Gilead-sponsored HCV study and did not attain
sustained virologic response 24 weeks after discontinuation of therapy (SVR24) on
a regimen containing:

- Sofosbuvir+RBV

- Peg-IFN and/or RBV in combination with one or more Gilead investigational
direct-acting agents
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnant or nursing female or male with pregnant female partner

- Current or prior history of clinical hepatic decompensation

- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

- Chronic use of systemically administered immunosuppressive agents

- Active drug abuse

- Use of any prohibited concomitant medications

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



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
1/06/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2014
Sample size
Target
Accrual to date
Final
534
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
Gallipoli Medical Research Foundation - Greenslopes
Recruitment hospital [4] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [6] 0 0
Monash Medical Centre - Melbourne
Recruitment hospital [7] 0 0
B2 Clinic - Fremantle
Recruitment hospital [8] 0 0
Canberra Hospital - Australian Capital Territory
Recruitment hospital [9] 0 0
St. Vincent's Hospital - Fitzroy
Recruitment hospital [10] 0 0
Royal Brisbane & Women's Hospital - Herston
Recruitment hospital [11] 0 0
St George Hospital - Kogarah
Recruitment hospital [12] 0 0
Royal Prince Alfred Hospital, Camperdown - NSW
Recruitment hospital [13] 0 0
Royal Perth Hospital - Perth Western Australia
Recruitment hospital [14] 0 0
Princess Alexandra Hospital - State of Queensland
Recruitment hospital [15] 0 0
Box Hill Hospital - Victoria
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4120 - Greenslopes
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
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3084 - Heidelberg
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3168 - Melbourne
Recruitment postcode(s) [7] 0 0
6160 - Fremantle
Recruitment postcode(s) [8] 0 0
2605 - Australian Capital Territory
Recruitment postcode(s) [9] 0 0
3065 - Fitzroy
Recruitment postcode(s) [10] 0 0
QLD 4029 - Herston
Recruitment postcode(s) [11] 0 0
2217 - Kogarah
Recruitment postcode(s) [12] 0 0
2050 - NSW
Recruitment postcode(s) [13] 0 0
6000 - Perth Western Australia
Recruitment postcode(s) [14] 0 0
4102 - State of Queensland
Recruitment postcode(s) [15] 0 0
3128 - Victoria
Recruitment outside Australia
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United States of America
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Alabama
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California
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Texas
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Virginia
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Washington
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Austria
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Graz
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Austria
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Vienna
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Austria
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Wien
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British Columbia
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Ontario
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Canada
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Vancouver
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Czech Republic
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Praha 4
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Estonia
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Tallinn
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Estonia
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Tartu
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Paris Cedex 12
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France
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Paris Cedex 13
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France
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Pessac Cedex
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France
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Rennes Cedex 9
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Strasbourg
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Vandoeuvre-les-Nancy
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Berlin
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Heidelberg
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Herne
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Kiel
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Leipzig
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Muenster
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Munich
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Wurzburg
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Foggia
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Florence
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Milano
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Milan
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Padova
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Parma
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Italy
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Roma
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Italy
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Rome
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Italy
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Turin
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Amsterdam
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Auckland
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BOP
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Bialystok
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Chorzow
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Lodz
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Myslowice
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Warsaw
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Barcelona
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Malaga
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Sevilla
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Göteborg
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Malmo
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Stockholm
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London
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United Kingdom
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Birmingham
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Hampshire
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Manchester
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United Kingdom
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Nottingham

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

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977)
in combination with ribavirin (RBV) with or without pegylated interferon (Peg-IFN) in adults
with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead HCV study
and have not achieved sustained virologic response (SVR).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01625338
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01625338