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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02378935




Registration number
NCT02378935
Ethics application status
Date submitted
27/02/2015
Date registered
4/03/2015

Titles & IDs
Public title
Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Genotype 1 HCV Infection
Scientific title
A Phase 2, Global, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-9857 Plus Sofosbuvir/GS-5816 Fixed Dose Combination in Subjects With Chronic Genotype 1 HCV Infection
Secondary ID [1] 0 0
GS-US-367-1168
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C Virus Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
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 - VOX
Treatment: Drugs - SOF/VEL
Treatment: Drugs - RBV

Experimental: VOX+SOF/VEL 6 wk, TN, without cirrhosis - VOX + SOF/VEL for 6 weeks (treatment naive (TN), without cirrhosis)

Experimental: VOX+SOF/VEL 8 wk, TN, without cirrhosis - VOX + SOF/VEL for 8 weeks (treatment naive, without cirrhosis)

Experimental: VOX+SOF/VEL 6 wk, TN, with cirrhosis - VOX + SOF/VEL for 6 weeks (treatment naive, with cirrhosis)

Experimental: VOX+SOF/VEL 8 wk, TN, with cirrhosis - VOX + SOF/VEL for 8 weeks (treatment naive, with cirrhosis)

Experimental: VOX+SOF/VEL+RBV 8 wk, TN, with cirrhosis - VOX + SOF/VEL+RBV for 8 weeks (treatment naive, with cirrhosis)

Experimental: VOX+SOF/VEL 8 wk, DAA-E, without cirrhosis - VOX + SOF/VEL for 8 weeks (direct-acting antiviral experienced (DAA-E), without cirrhosis)

Experimental: VOX+SOF/VEL 12 wk, DAA-E, without cirrhosis - VOX + SOF/VEL for 12 weeks (direct-acting antiviral experienced, without cirrhosis)

Experimental: VOX+SOF/VEL 8 wk, DAA-E, with cirrhosis - GS-9857 + SOF/VEL for 8 weeks (direct-acting antiviral experienced, with cirrhosis)

Experimental: VOX+SOF/VEL 12 wk, DAA-E, with cirrhosis - GS-9857 + SOF/VEL for 12 weeks (direct-acting antiviral experienced, with cirrhosis)

Experimental: VOX+SOF/VEL 12 wk (GS-US-338-1121) - VOX + SOF/VEL for 12 weeks (participants who were previously enrolled in GS-US-338-1121 phase 1b study)


Treatment: Drugs: VOX
100 mg tablet(s) administered orally once daily with food

Treatment: Drugs: SOF/VEL
400/100 mg FDC tablet administered orally once daily with food

Treatment: Drugs: 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)
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 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 Sustained Virologic Response 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 HCV RNA < LLOQ on Treatment
Timepoint [2] 0 0
Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
Secondary outcome [3] 0 0
HCV RNA Change From Baseline
Timepoint [3] 0 0
Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
Secondary outcome [4] 0 0
Percentage of Participants With Virologic Failure
Timepoint [4] 0 0
Up to Posttreatment Week 24

Eligibility
Key inclusion criteria
Key

* Individuals with chronic HCV infection
* HCV RNA =10^4 IU/mL at screening
* HCV genotype 1
* Cirrhosis determination; a liver biopsy may be required
* Screening laboratory values within defined thresholds
* Use of two contraception methods if female of childbearing potential or sexually active male

Key
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
* Current or prior history of hepatic decompensation
* Hepatocellular carcinoma (HCC) or other clinically significant malignancy
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
* History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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
Other
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
17/02/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/04/2016
Sample size
Target
Accrual to date
Final
205
Recruitment in Australia
Recruitment state(s)
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
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New Mexico
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
South Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
New Zealand
State/province [19] 0 0
Auckland
Country [20] 0 0
New Zealand
State/province [20] 0 0
Christchurch
Country [21] 0 0
Puerto Rico
State/province [21] 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
Gilead Study Director
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 https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.

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: https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Lawitz E, Reau N, Hinestrosa F, Rabinovitz M, Schi... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT02378935