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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02639338




Registration number
NCT02639338
Ethics application status
Date submitted
21/12/2015
Date registered
24/12/2015

Titles & IDs
Public title
Safety and Efficacy of SOF/VEL/VOX FDC for 8 Weeks and SOF/VEL for 12 Weeks in Adults Chronic Genotype 3 HCV Infection and Cirrhosis
Scientific title
A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 8 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks in Subjects With Chronic Genotype 3 HCV Infection and Cirrhosis
Secondary ID [1] 0 0
2015-002996-12
Secondary ID [2] 0 0
GS-US-367-1173
Universal Trial Number (UTN)
Trial acronym
POLARIS-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/VOX
Treatment: Drugs - SOF/VEL

Experimental: SOF/VEL/VOX - SOF/VEL/VOX tablet for 8 weeks

Experimental: SOF/VEL - SOF/VEL tablet for 12 weeks


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

Treatment: Drugs: SOF/VEL
400/100 mg FDC tablet administered orally once daily without regard to food
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 Discontinue 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 HCV RNA < LLOQ On Treatment
Timepoint [2] 0 0
Weeks 1, 2, 4, 8 and 12
Secondary outcome [3] 0 0
Change From Baseline in HCV RNA
Timepoint [3] 0 0
Weeks 1, 2, 4, 8 and 12
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

* Willing and able to provide written informed consent
* HCV RNA = 10^4 IU/mL at screening
* Chronic genotype 3 HCV infection (= 6 months)
* Presence of cirrhosis
* HCV treatment naive or treatment experienced with an interferon (IFN)-based regimen
* Use of protocol specified methods of contraception

Key
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 that may interfere with participation in the study
* Screening ECG with clinically significant abnormalities
* Laboratory parameters outside the acceptable range at screening
* Pregnant or nursing female
* Chronic liver disease not caused by HCV
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

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

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
23/12/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/01/2017
Sample size
Target
Accrual to date
Final
220
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- Darlinghurst
Recruitment hospital [3] 0 0
- Herston
Recruitment hospital [4] 0 0
- Clayton
Recruitment hospital [5] 0 0
- Fitzroy
Recruitment hospital [6] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Darlinghurst
Recruitment postcode(s) [3] 0 0
- Herston
Recruitment postcode(s) [4] 0 0
- Clayton
Recruitment postcode(s) [5] 0 0
- Fitzroy
Recruitment postcode(s) [6] 0 0
- Melbourne
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
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United States of America
State/province [4] 0 0
Georgia
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United States of America
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Indiana
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United States of America
State/province [6] 0 0
Louisiana
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
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Michigan
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United States of America
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New Jersey
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New York
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United States of America
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North Carolina
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United States of America
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Pennsylvania
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United States of America
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Rhode Island
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United States of America
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Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
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Utah
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United States of America
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Virginia
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United States of America
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Washington
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Canada
State/province [20] 0 0
Alberta
Country [21] 0 0
Canada
State/province [21] 0 0
British Columbia
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
Country [23] 0 0
France
State/province [23] 0 0
Bobigny
Country [24] 0 0
France
State/province [24] 0 0
Clermont-Ferrand
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France
State/province [25] 0 0
Clichy
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France
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Creteil
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France
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Limoges
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France
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Lyon
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France
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Marseille
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France
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Montpellier
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France
State/province [31] 0 0
Nice
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France
State/province [32] 0 0
Orleans
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France
State/province [33] 0 0
Paris
Country [34] 0 0
France
State/province [34] 0 0
Pessac
Country [35] 0 0
France
State/province [35] 0 0
Rennes
Country [36] 0 0
France
State/province [36] 0 0
Strasbourg
Country [37] 0 0
France
State/province [37] 0 0
Vandoeuvre-les-Nancy
Country [38] 0 0
Germany
State/province [38] 0 0
Berlin
Country [39] 0 0
Germany
State/province [39] 0 0
Bonn
Country [40] 0 0
Germany
State/province [40] 0 0
Frankfurt am Main
Country [41] 0 0
Germany
State/province [41] 0 0
Hamburg
Country [42] 0 0
Germany
State/province [42] 0 0
Hannover
Country [43] 0 0
Germany
State/province [43] 0 0
Köln
Country [44] 0 0
New Zealand
State/province [44] 0 0
Auckland
Country [45] 0 0
New Zealand
State/province [45] 0 0
Christchurch
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Puerto Rico
State/province [46] 0 0
San Juan
Country [47] 0 0
United Kingdom
State/province [47] 0 0
London
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Manchester
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United Kingdom
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Nottingham
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United Kingdom
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Oxford
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United Kingdom
State/province [51] 0 0
Portsmouth

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/about/ethics-and-code-of-conduct/policies.

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/about/ethics-and-code-of-conduct/policies


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/NCT02639338