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Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir in Adults With Chronic HCV Infection Who Have Previously Received Treatment With Direct-Acting Antiviral Therapy (POLARIS-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02607735
Recruitment Status : Completed
First Posted : November 18, 2015
Results First Posted : December 13, 2017
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE November 16, 2015
First Posted Date  ICMJE November 18, 2015
Results First Submitted Date  ICMJE October 4, 2017
Results First Posted Date  ICMJE December 13, 2017
Last Update Posted Date March 5, 2019
Actual Study Start Date  ICMJE November 11, 2015
Actual Primary Completion Date October 10, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2017)
  • Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Primary Study) [ Time Frame: Posttreatment Week 12 ]
    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.
  • Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event (Primary Study) [ Time Frame: Up to 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 16, 2015)
  • Proportion of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Primary Study) [ Time Frame: Posttreatment Week 12 ]
    SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.
  • Proportion of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event [ Time Frame: Up to 12 weeks ]
Change History Complete list of historical versions of study NCT02607735 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2018)
  • Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) (Primary Study) [ Time Frame: Posttreatment Week 4 ]
    SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment, respectively.
  • Percentage of Participants With HCV RNA < LLOQ On Treatment (Primary Study) [ Time Frame: Weeks 1, 2, 4, 8 and 12 ]
  • Change From Baseline in HCV RNA (Primary Study) [ Time Frame: Baseline; Weeks 1, 2, 4, 8 and 12 ]
  • Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) (Primary Study) [ Time Frame: Posttreatment Week 24 ]
    SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.
  • Percentage of Participants With Virologic Failure (Primary Study) [ Time Frame: Up to Posttreatment Week 24 ]
    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.
  • Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (Deferred Treatment Substudy) [ Time Frame: Posttreatment Weeks 4, 12, and 24 (Deferred Treatment Substudy) ]
    SVR4, SVR12 and SVR24 was defined as HCV RNA < LLOQ at 4, 12 and 24 weeks after stopping study treatment, respectively.
  • Percentage of Participants With HCV RNA < LLOQ On Treatment (Deferred Treatment Substudy) [ Time Frame: Weeks 1, 2, 4, 8 and 12 (Deferred Treatment Substudy) ]
  • Change From Baseline in HCV RNA (Deferred Treatment Substudy) [ Time Frame: Baseline; Weeks 1, 2, 4, 8, and 12 (Deferred Treatment Substudy) ]
  • Percentage of Participants With Virologic Failure (Deferred Treatment Substudy) [ Time Frame: Up to Posttreatment Week 24 (Deferred Treatment Substudy) ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2015)
  • Proportion of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) (Primary Study) [ Time Frame: Posttreatment Weeks 4 and 24 ]
    SVR4 and SVR 24 are defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
  • Proportion of Participants With HCV RNA < LLOQ On Treatment (Primary Study) [ Time Frame: Up to 12 weeks ]
  • Change From Baseline in HCV RNA (Primary Study) [ Time Frame: Up to 12 weeks ]
  • Proportion of Participants With Virologic Failure (Primary Study) [ Time Frame: Up to Posttreatment Week 24 ]
    Virologic failure is defined as:
    • On-treatment virologic failure:
      • Confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment, or
      • Confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, or
      • HCV RNA persistently ≥ LLOQ through 8 weeks of treatment
    • Viral relapse
  • Proportion of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (Deferred Treatment Substudy) [ Time Frame: Posttreatment Weeks 4, 12, and 24 on active treatment ]
    This outcome will be assessed in participants randomized to placebo who later enroll in deferred treatment.
  • Proportion of Participants With HCV RNA < LLOQ On Treatment (Deferred Treatment Substudy) [ Time Frame: Up to 12 weeks on active treatment ]
    This outcome will be assessed in participants randomized to placebo who later enroll in deferred treatment.
  • Change From Baseline in HCV RNA (Deferred Treatment Substudy) [ Time Frame: Up to 12 weeks on active treatment ]
    This outcome will be assessed in participants randomized to placebo who later enroll in deferred treatment.
  • Proportion of Participants With Virologic Failure (Deferred Treatment Substudy) [ Time Frame: Up to Posttreatment Week 24 on active treatment ]
    This outcome will be assessed in participants randomized to placebo who later enroll in deferred treatment.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir in Adults With Chronic HCV Infection Who Have Previously Received Treatment With Direct-Acting Antiviral Therapy
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C
Intervention  ICMJE
  • Drug: SOF/VEL/VOX
    400/100/100 mg fixed dose-combination (FDC) tablet administered orally once daily with food
    Other Names:
    • Vosevi®
    • GS-7977/GS-5816/GS-9857
  • Drug: Placebo
    Tablet administered orally once daily with food
Study Arms  ICMJE
  • Experimental: SOF/VEL/VOX (Primary Study)
    SOF/VEL/VOX for 12 weeks
    Intervention: Drug: SOF/VEL/VOX
  • Experimental: Placebo (Primary Study)
    Placebo to match SOF/VEL/VOX for 12 weeks
    Intervention: Drug: Placebo
  • Experimental: SOF/VEL/VOX (Deferred Treatment Substudy)
    SOF/VEL/VOX for 12 weeks for eligible participants initially randomized to receive placebo
    Intervention: Drug: SOF/VEL/VOX
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 22, 2016)
416
Original Estimated Enrollment  ICMJE
 (submitted: November 16, 2015)
380
Actual Study Completion Date  ICMJE June 21, 2017
Actual Primary Completion Date October 10, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • 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

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   France,   Germany,   New Zealand,   Puerto Rico,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02607735
Other Study ID Numbers  ICMJE GS-US-367-1171
2015-003455-21 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: 18 months after study completion
Access Criteria: A secured external environment with username, password, and RSA code.
URL: https://www.gilead.com/about/ethics-and-code-of-conduct/policies
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP