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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02607735
Registration number
NCT02607735
Ethics application status
Date submitted
16/11/2015
Date registered
18/11/2015
Titles & IDs
Public title
Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir in Adults With Chronic HCV Infection Who Have Previously Received Treatment With Direct-Acting Antiviral Therapy
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Scientific title
A Phase 3, Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects With Chronic HCV Infection
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Secondary ID [1]
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2015-003455-21
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Secondary ID [2]
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GS-US-367-1171
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Universal Trial Number (UTN)
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Trial acronym
POLARIS-1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatitis C
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Condition category
Condition code
Infection
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0
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Studies of infection and infectious agents
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Infection
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0
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Other infectious diseases
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Oral and Gastrointestinal
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - SOF/VEL/VOX
Treatment: Drugs - Placebo
Experimental: SOF/VEL/VOX (Primary Study) - SOF/VEL/VOX for 12 weeks
Experimental: Placebo (Primary Study) - Placebo to match SOF/VEL/VOX for 12 weeks
Experimental: SOF/VEL/VOX (Deferred Treatment Substudy) - SOF/VEL/VOX for 12 weeks for eligible participants initially randomized to receive placebo
Treatment: Drugs: SOF/VEL/VOX
400/100/100 mg fixed dose-combination (FDC) tablet administered orally once daily with food
Treatment: Drugs: Placebo
Tablet administered orally once daily with food
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Primary Study)
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Assessment method [1]
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SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.
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Timepoint [1]
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Posttreatment Week 12
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Primary outcome [2]
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Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event (Primary Study)
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Assessment method [2]
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Timepoint [2]
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Up to 12 weeks
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Secondary outcome [1]
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Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) (Primary Study)
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Assessment method [1]
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SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment, respectively.
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Timepoint [1]
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Posttreatment Week 4
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Secondary outcome [2]
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Percentage of Participants With HCV RNA < LLOQ On Treatment (Primary Study)
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Assessment method [2]
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Timepoint [2]
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Weeks 1, 2, 4, 8 and 12
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Secondary outcome [3]
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Change From Baseline in HCV RNA (Primary Study)
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Assessment method [3]
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Timepoint [3]
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Baseline; Weeks 1, 2, 4, 8 and 12
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Secondary outcome [4]
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Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) (Primary Study)
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Assessment method [4]
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SVR24 was defined as HCV RNA \< LLOQ at 24 weeks after stopping study treatment.
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Timepoint [4]
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Posttreatment Week 24
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Secondary outcome [5]
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Percentage of Participants With Virologic Failure (Primary Study)
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Assessment method [5]
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Virologic failure is defined as:
* On-treatment virologic failure:
* Breakthrough (confirmed HCV RNA = LLOQ after having previously had HCV RNA LLOQ while on treatment), or
* Rebound (confirmed 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
* Non-response (HCV RNA persistently = LLOQ through 8 weeks of treatment)
* Virologic relapse:
* Confirmed HCV RNA = LLOQ during the posttreatment period having achieved HCV RNA LLOQ at last on-treatment visit.
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Timepoint [5]
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Up to Posttreatment Week 24
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Secondary outcome [6]
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Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (Deferred Treatment Substudy)
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Assessment method [6]
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SVR4, SVR12 and SVR24 was defined as HCV RNA \< LLOQ at 4, 12 and 24 weeks after stopping study treatment, respectively.
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Timepoint [6]
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Posttreatment Weeks 4, 12, and 24 (Deferred Treatment Substudy)
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Secondary outcome [7]
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Percentage of Participants With HCV RNA < LLOQ On Treatment (Deferred Treatment Substudy)
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Assessment method [7]
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Timepoint [7]
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Weeks 1, 2, 4, 8 and 12 (Deferred Treatment Substudy)
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Secondary outcome [8]
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Change From Baseline in HCV RNA (Deferred Treatment Substudy)
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Assessment method [8]
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Timepoint [8]
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Baseline; Weeks 1, 2, 4, 8, and 12 (Deferred Treatment Substudy)
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Secondary outcome [9]
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Percentage of Participants With Virologic Failure (Deferred Treatment Substudy)
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Assessment method [9]
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Virologic failure is defined as:
* On-treatment virologic failure:
* Breakthrough (confirmed HCV RNA = LLOQ after having previously had HCV RNA LLOQ while on treatment), or
* Rebound (confirmed 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
* Non-response (HCV RNA persistently = LLOQ through 8 weeks of treatment)
* Virologic relapse:
* Confirmed HCV RNA = LLOQ during the posttreatment period having achieved HCV RNA LLOQ at last on-treatment visit.
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Timepoint [9]
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Up to Posttreatment Week 24 (Deferred Treatment Substudy)
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Eligibility
Key inclusion criteria
Key
* Willing and able to provide written informed consent
* HCV RNA = 10^4 IU/mL at screening
* Chronic HCV infection (= 6 months)
* Treatment experienced with a direct acting antiviral medication for HCV
* Use of protocol specified methods of contraception
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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 results outside of acceptable ranges 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/11/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
21/06/2017
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Sample size
Target
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Accrual to date
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Final
416
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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- Camperdown
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Recruitment hospital [2]
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- Darlinghurst
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- Herston
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Recruitment hospital [4]
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- Clayton
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- Fitzroy
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- Melbourne
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- Camperdown
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- Darlinghurst
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Recruitment postcode(s) [3]
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- Herston
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Recruitment postcode(s) [4]
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- Clayton
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Recruitment postcode(s) [5]
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- Fitzroy
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Recruitment postcode(s) [6]
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- Melbourne
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Recruitment outside Australia
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United States of America
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California
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Portsmouth
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Gilead Sciences
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objectives of this study are to evaluate the safety and efficacy of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic hepatitis C virus (HCV) infection who have previously received treatment with direct-acting antiviral therapy. Participants randomized to placebo may be eligible for deferred treatment with active SOF/VEL/VOX.
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Trial website
https://clinicaltrials.gov/study/NCT02607735
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Trial related presentations / publications
Bourlière M, Gordon SC, Ramji A, Ravendhran N, Tran TT, Hyland RH, et al. Sofosbuvir/Velpatasvir/Voxilaprevir for 12 Weeks as a Salvage Regimen in NS5A Inhibitor-Experienced Patients with Genotype 1-6 Infection: The Phase 3 POLARIS-1 Study [Abstract 194]. J Hepatology 2016;63 (1S):102A. Younossi ZM, Stepanova M, Gordon S, Zeuzem S, Mann MP, Jacobson I, Bourliere M, Cooper C, Flamm S, Reddy KR, Kowdley K, Younossi I, Hunt S. Patient-Reported Outcomes Following Treatment of Chronic Hepatitis C Virus Infection With Sofosbuvir and Velpatasvir, With or Without Voxilaprevir. Clin Gastroenterol Hepatol. 2018 Apr;16(4):567-574.e6. doi: 10.1016/j.cgh.2017.11.023. Epub 2017 Nov 16. Bourliere M, Gordon SC, Schiff ER, Tran TT, Ravendhran N, Landis CS, Hyland RH, Stamm LM, Zhang J, Dvory-Sobol H, Subramanian GM, Brainard DM, McHutchison JG, Serfaty L, Thompson AJ, Sepe TE, Curry MP, Reddy KR, Manns MP. Deferred treatment with sofosbuvir-velpatasvir-voxilaprevir for patients with chronic hepatitis C virus who were previously treated with an NS5A inhibitor: an open-label substudy of POLARIS-1. Lancet Gastroenterol Hepatol. 2018 Aug;3(8):559-565. doi: 10.1016/S2468-1253(18)30118-3. Epub 2018 May 31. Bourliere M, Gordon SC, Flamm SL, Cooper CL, Ramji A, Tong M, Ravendhran N, Vierling JM, Tran TT, Pianko S, Bansal MB, de Ledinghen V, Hyland RH, Stamm LM, Dvory-Sobol H, Svarovskaia E, Zhang J, Huang KC, Subramanian GM, Brainard DM, McHutchison JG, Verna EC, Buggisch P, Landis CS, Younes ZH, Curry MP, Strasser SI, Schiff ER, Reddy KR, Manns MP, Kowdley KV, Zeuzem S; POLARIS-1 and POLARIS-4 Investigators. Sofosbuvir, Velpatasvir, and Voxilaprevir for Previously Treated HCV Infection. N Engl J Med. 2017 Jun 1;376(22):2134-2146. doi: 10.1056/NEJMoa1613512.
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Public notes
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Contacts
Principal investigator
Name
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Gilead Study Director
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Address
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Gilead Sciences
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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)
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When will data be available (start and end dates)?
18 months after study completion
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Available to whom?
A secured external environment with username, password, and RSA code.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.gilead.com/about/ethics-and-code-of-conduct/policies
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Bourliere M, Gordon SC, Flamm SL, Cooper CL, Ramji...
[
More Details
]
Results are available at
https://clinicaltrials.gov/study/NCT02607735