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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02201953




Registration number
NCT02201953
Ethics application status
Date submitted
24/07/2014
Date registered
28/07/2014

Titles & IDs
Public title
Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Adults With Chronic Genotype 3 HCV Infection
Scientific title
A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Subjects With Chronic Genotype 3 HCV Infection
Secondary ID [1] 0 0
2014-001682-27
Secondary ID [2] 0 0
GS-US-342-1140
Universal Trial Number (UTN)
Trial acronym
ASTRAL-3
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 - SOF/VEL
Treatment: Drugs - SOF
Treatment: Drugs - RBV

Experimental: SOF/VEL 12 Weeks - SOF/VEL FDC for 12 weeks

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


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

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

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 (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 HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Timepoint [2] 0 0
Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Secondary outcome [3] 0 0
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Timepoint [3] 0 0
Baseline; Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Secondary outcome [4] 0 0
Percentage of Participants With Virologic Failure
Timepoint [4] 0 0
Up to Posttreatment Week 24

Eligibility
Key inclusion criteria
* Willing and able to provide written informed consent
* HCV RNA = 10^4 IU/mL
* HCV genotype 3
* Chronic HCV infection (= 6 months)
* Females of childbearing potential must have a negative serum pregnancy test
* Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
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) that may interfere with subject treatment, assessment or compliance with the protocol
* Screening ECG with clinically significant abnormalities
* Laboratory results outside of acceptable ranges at Screening
* Pregnant or nursing female or male with pregnant female partner
* Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, cholangitis)
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

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 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
1/07/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2015
Sample size
Target
Accrual to date
Final
558
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
- Darlinghurst
Recruitment hospital [2] 0 0
- Brisbane
Recruitment hospital [3] 0 0
- Clayton
Recruitment hospital [4] 0 0
- Fitzroy, Melbourne
Recruitment hospital [5] 0 0
- Melbourne
Recruitment hospital [6] 0 0
- Fremantle
Recruitment hospital [7] 0 0
- Perth
Recruitment hospital [8] 0 0
- Camperdown
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4064 - Brisbane
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy, Melbourne
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment postcode(s) [6] 0 0
6010 - Fremantle
Recruitment postcode(s) [7] 0 0
6000 - Perth
Recruitment postcode(s) [8] 0 0
- Camperdown
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 York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia
Country [16] 0 0
Canada
State/province [16] 0 0
Alberta
Country [17] 0 0
Canada
State/province [17] 0 0
British Columbia
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec
Country [20] 0 0
Canada
State/province [20] 0 0
Toronto
Country [21] 0 0
France
State/province [21] 0 0
Clermont-Ferrand
Country [22] 0 0
France
State/province [22] 0 0
Clichy
Country [23] 0 0
France
State/province [23] 0 0
Creteil
Country [24] 0 0
France
State/province [24] 0 0
Lille
Country [25] 0 0
France
State/province [25] 0 0
Limoges
Country [26] 0 0
France
State/province [26] 0 0
Lyon
Country [27] 0 0
France
State/province [27] 0 0
Marseille
Country [28] 0 0
France
State/province [28] 0 0
Paris
Country [29] 0 0
France
State/province [29] 0 0
Pessac
Country [30] 0 0
France
State/province [30] 0 0
Toulouse
Country [31] 0 0
France
State/province [31] 0 0
Villejuif
Country [32] 0 0
Germany
State/province [32] 0 0
Hessin
Country [33] 0 0
Germany
State/province [33] 0 0
North Rhine-Westphalia
Country [34] 0 0
Germany
State/province [34] 0 0
NRW
Country [35] 0 0
Germany
State/province [35] 0 0
Berlin
Country [36] 0 0
Germany
State/province [36] 0 0
Hamburg
Country [37] 0 0
Germany
State/province [37] 0 0
Hannover
Country [38] 0 0
Germany
State/province [38] 0 0
München
Country [39] 0 0
Italy
State/province [39] 0 0
Foggia
Country [40] 0 0
Italy
State/province [40] 0 0
Firenze
Country [41] 0 0
New Zealand
State/province [41] 0 0
Auckland
Country [42] 0 0
New Zealand
State/province [42] 0 0
Christchurch
Country [43] 0 0
Puerto Rico
State/province [43] 0 0
San Juan
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Devon
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Hampshire
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Glasgow
Country [47] 0 0
United Kingdom
State/province [47] 0 0
London
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Manchester
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Nottingham
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Oxford

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, PhD
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/NCT02201953