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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02607735
First Posted: November 18, 2015
Last Update Posted: November 15, 2017
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.
Information provided by (Responsible Party):
Gilead Sciences
  Purpose

This study will evaluate the safety and efficacy of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic HCV infection who have previously received treatment with direct-acting antiviral therapy.

Subjects randomized to placebo may be eligible for deferred treatment with active SOF/VEL/VOX.


Condition Intervention Phase
Hepatitis C Drug: SOF/VEL/VOX Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Enrollment: 416
Actual Study Start Date: November 2015
Study Completion Date: June 21, 2017
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SOF/VEL/VOX (Primary Study)
SOF/VEL/VOX tablet for 12 weeks
Drug: SOF/VEL/VOX
SOF/VEL/VOX tablet administered orally once daily
Other Name: GS-7977/GS-5816/GS-9857
Experimental: Placebo (Primary Study)
Placebo to match SOF/VEL/VOX tablet for 12 weeks
Drug: Placebo
SOF/VEL/VOX placebo tablet administered orally once daily
Experimental: SOF/VEL/VOX (Deferred Treatment Substudy)
SOF/VEL/VOX tablet for 12 weeks for eligible participants initially randomized to receive placebo
Drug: SOF/VEL/VOX
SOF/VEL/VOX tablet administered orally once daily
Other Name: GS-7977/GS-5816/GS-9857

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02607735


  Show 86 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Robert H. Hyland, DPhil Gilead Sciences
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02607735     History of Changes
Other Study ID Numbers: GS-US-367-1171
2015-003455-21 ( EudraCT Number )
First Submitted: November 16, 2015
First Posted: November 18, 2015
Last Update Posted: November 15, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gilead Sciences:
Chronic Hepatitis C Infection

Additional relevant MeSH terms:
Infection
Hepatitis
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Antiviral Agents
Sofosbuvir
Anti-Infective Agents