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Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination in Participants With Chronic Hepatitis C Virus Infection

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: NCT02722837
Recruitment Status : Completed
First Posted : March 30, 2016
Results First Posted : July 17, 2018
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE March 24, 2016
First Posted Date  ICMJE March 30, 2016
Results First Submitted Date  ICMJE June 20, 2018
Results First Posted Date  ICMJE July 17, 2018
Last Update Posted Date November 16, 2018
Actual Study Start Date  ICMJE April 4, 2016
Actual Primary Completion Date June 26, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2018)
  • Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) [ 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 [ Time Frame: Up to 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 24, 2016)
  • Proportion of Participants with Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) [ 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
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2018)
  • Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Therapy (SVR4) [ Time Frame: Posttreatment Week 4 ]
    SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.
  • Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24) [ Time Frame: Posttreatment Week 24 ]
    SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.
  • Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 1 [ Time Frame: Week 1 ]
  • Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 2 [ Time Frame: Week 2 ]
  • Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 4 [ Time Frame: Week 4 ]
  • Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 8 [ Time Frame: Week 8 ]
  • Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 12 [ Time Frame: Week 12 ]
  • Change From Baseline in HCV RNA at Week 1 [ Time Frame: Baseline (Day 1); Week 1 ]
  • Change From Baseline in HCV RNA at Week 2 [ Time Frame: Baseline (Day 1); Week 2 ]
  • Change From Baseline in HCV RNA at Week 4 [ Time Frame: Baseline (Day 1); Week 4 ]
  • Change From Baseline in HCV RNA at Week 8 [ Time Frame: Baseline (Day 1); Week 8 ]
  • Change From Baseline in HCV RNA at Week 12 [ Time Frame: Baseline (Day 1); Week 12 ]
  • Percentage of Participants With Virologic Failure [ Time Frame: Up to Posttreatment Week 24 ]
    Virologic failure was defined as:
    • 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), or
    • Relapse (HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement)
Original Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2016)
  • Proportion of Participants with HCV RNA < LLOQ at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) [ Time Frame: Posttreatment Weeks 4 and 24 ]
    SVR4 and SVR24 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 [ Time Frame: Up to 12 weeks ]
  • Change in HCV RNA From Day 1 [ Time Frame: Day 1 and up to 12 weeks ]
  • Proportion of Participants with Virologic Failure [ Time Frame: Up to Posttreatment Week 24 ]
    Virologic failure is defined as:
    • 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), or
    • Relapse (HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination in Participants With Chronic Hepatitis C Virus Infection
Official Title  ICMJE A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Subjects With Chronic Hepatitis C Virus (HCV) Infection
Brief Summary The primary objective of this study is to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C Virus Infection
Intervention  ICMJE Drug: SOF/VEL
400/100 mg FDC tablet administered orally once daily
Other Names:
  • GS-7977/GS-5816
  • Epclusa®
Study Arms  ICMJE Experimental: SOF/VEL
SOF/VEL for 12 weeks
Intervention: Drug: SOF/VEL
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: February 6, 2017)
119
Original Estimated Enrollment  ICMJE
 (submitted: March 24, 2016)
120
Actual Study Completion Date  ICMJE September 13, 2017
Actual Primary Completion Date June 26, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • HCV RNA ≥ 10^4 IU/mL at screening
  • Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy

Key Exclusion Criteria:

  • Any other chronic liver disease
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
  • Clinical hepatic decompensation
  • Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor

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 Russian Federation,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02722837
Other Study ID Numbers  ICMJE GS-US-342-1522
2015-003001-42 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
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 http://www.gilead.com/research/disclosure-and-transparency.
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: http://www.gilead.com/research/disclosure-and-transparency
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 June 2018

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