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Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Participants With Chronic HCV

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: NCT02671500
Recruitment Status : Completed
First Posted : February 2, 2016
Results First Posted : January 8, 2019
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE January 29, 2016
First Posted Date  ICMJE February 2, 2016
Results First Submitted Date  ICMJE December 20, 2018
Results First Posted Date  ICMJE January 8, 2019
Last Update Posted Date January 8, 2019
Actual Study Start Date  ICMJE April 19, 2016
Actual Primary Completion Date January 5, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 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; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
  • Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event [ Time Frame: Up to 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 29, 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: December 20, 2018)
  • Percentage of Participants With SVR 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 SVR at 24 Weeks After Discontinuation of Therapy (SVR24) [ Time Frame: Posttreatment Week 24 ]
    SVR 24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.
  • Percentage of Participants With HCV RNA < LLOQ On Treatment [ Time Frame: Weeks 1, 2, 4, 6, 8, 10, and 12 ]
  • Change From Baseline in HCV RNA [ Time Frame: Baseline and up to Week 12 ]
  • Percentage of Participants With Overall Virologic Failure [ Time Frame: Up to Posttreatment Week 24 ]
    Virologic failure was defined as: (1) 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) or (2) 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: January 29, 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 for 12 Weeks in Participants With Chronic HCV
Official Title  ICMJE A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic HCV
Brief Summary The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir (SOF)/velpatasvir (VEL; GS-5816) 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 Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C Virus Infection
Intervention  ICMJE Drug: SOF/VEL
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 FDC 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: August 9, 2017)
375
Original Estimated Enrollment  ICMJE
 (submitted: January 29, 2016)
360
Actual Study Completion Date  ICMJE March 27, 2018
Actual Primary Completion Date January 5, 2018   (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) documented by prior medical history or liver biopsy
  • Any HCV genotype (1, 2, 3, 4, 5, 6 or indeterminate)
  • HCV treatment-naive or treatment-experienced
  • Liver imaging within 6 months of Day 1 is required in cirrhotic patients only to exclude hepatocellular carcinoma (HCC)

Key Exclusion Criteria:

  • Current or prior history of clinically-significant illness (other than HCV), gastrointestinal disorder, clinical hepatic decompensation, or post-operative condition that could interfere with the absorption of the study drug
  • Pregnant or nursing female or male with pregnant female partner
  • Chronic liver disease of a non HCV etiology
  • 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 China,   Malaysia,   Singapore,   Thailand,   Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02671500
Other Study ID Numbers  ICMJE GS-US-342-1518
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 December 2018

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