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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01909804




Registration number
NCT01909804
Ethics application status
Date submitted
17/07/2013
Date registered
29/07/2013

Titles & IDs
Public title
Safety and Efficacy of Sofosbuvir Plus Velpatasvir With or Without Ribavirin in Treatment-experienced Subjects With Chronic HCV Infection
Scientific title
A Phase 2, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir + GS-5816 for 12 Weeks in Treatment-Experienced Subjects With Chronic HCV Infection
Secondary ID [1] 0 0
GS-US-342-0109
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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 - VEL
Treatment: Drugs - RBV

Experimental: SOF+VEL 25 mg (GT3) without cirrhosis - Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 25 mg for 12 weeks.

Experimental: SOF+VEL 25mg+RBV (GT3) without cirrhosis - Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 25 mg plus RBV for 12 weeks.

Experimental: SOF+VEL 100 mg (GT3) without cirrhosis - Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 100 mg for 12 weeks.

Experimental: SOF+VEL 100 mg+RBV (GT3) without cirrhosis - Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 100 mg plus RBV for 12 weeks.

Experimental: SOF+VEL 25 mg (GT3) with cirrhosis - Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 25 mg for 12 weeks.

Experimental: SOF+VEL 25 mg+RBV (GT3) with cirrhosis - Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 25 mg plus RBV for 12 weeks.

Experimental: SOF+VEL 100 mg (GT3) with cirrhosis - Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 100 mg for 12 weeks.

Experimental: SOF+VEL 100 mg+RBV (GT3) with cirrhosis - Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 100 mg plus RBV for 12 weeks.

Experimental: SOF+VEL 25 mg (GT1) - Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 12 weeks.

Experimental: SOF+VEL 25 mg+RBV (GT1) - Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg plus RBV for 12 weeks.

Experimental: SOF+VEL 100 mg (GT1) - Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 12 weeks.

Experimental: SOF+VEL 100 mg+RBV (GT1) - Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg plus RBV for 12 weeks.


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

Treatment: Drugs: VEL
Tablet administered orally once daily

Treatment: Drugs: RBV
200 mg 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)
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 12 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 Virologic Failure
Timepoint [2] 0 0
Up to Posttreatment Week 24

Eligibility
Key inclusion criteria
* Body mass index (BMI) = 18 kg/m^2
* HCV RNA = 10000 IU/mL at screening
* Prior treatment failure to a regimen including interferon with or without RBV
* HCV genotype 1 or 3
* Chronic HCV infection
* Cirrhosis determination
* Use of highly effective contraception methods if female of childbearing potential or sexually active male
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Current or prior history of clinically significant illness other than HCV
* Screening ECG with clinically significant abnormalities
* Prior exposure to HCV specific direct acting antiviral agent
* Pregnant or nursing female or male with pregnant female partner
* Chronic liver disease of non-HCV etiology
* Hepatitis B
* Active drug abuse
* Use of any prohibited concomitant medications

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
Open (masking not used)
Who is / are masked / blinded?



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
1/06/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2014
Sample size
Target
Accrual to date
Final
323
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- Darlinghurst
Recruitment hospital [3] 0 0
- Clayton
Recruitment hospital [4] 0 0
- Melbourne
Recruitment hospital [5] 0 0
- Fremantle
Recruitment hospital [6] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Darlinghurst
Recruitment postcode(s) [3] 0 0
- Clayton
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment postcode(s) [5] 0 0
- Fremantle
Recruitment postcode(s) [6] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New Mexico
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Oregon
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
Rhode Island
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
New Zealand
State/province [21] 0 0
Auckland
Country [22] 0 0
New Zealand
State/province [22] 0 0
Christchurch
Country [23] 0 0
Puerto Rico
State/province [23] 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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John McNally
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
18 months after study completion
Available to whom?
A secured external environment with username, password, and RSA code.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.gilead.com/research/disclosure-and-transparency


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents



Results are available at https://clinicaltrials.gov/study/NCT01909804