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Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection in Participants With Chronic Genotype 1, 2, 3, or 6 HCV 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: NCT01826981
Recruitment Status : Completed
First Posted : April 9, 2013
Results First Posted : September 16, 2016
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE April 1, 2013
First Posted Date  ICMJE April 9, 2013
Results First Submitted Date  ICMJE July 28, 2016
Results First Posted Date  ICMJE September 16, 2016
Last Update Posted Date November 16, 2018
Study Start Date  ICMJE April 2013
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2016)
  • Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]
    SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) at 12 weeks after stopping study treatment.
  • Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s) [ Time Frame: Up to 24 weeks plus 30 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 4, 2013)
  • Sustained virologic response after discontinuation of therapy [ Time Frame: 12 weeks after discontinuation of therapy ]
    Sustained virologic response (SVR) 12 weeks after the end of treatment (SVR12 defined as HCV RNA < lower limit of quantification [LLOQ] 12 weeks after last dose of study drug).
  • Safety and tolerability of sofosbuvir-containing regimens [ Time Frame: 12 Weeks ]
    Adverse events leading to permanent discontinuation of study drug(s).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2016)
  • Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment [ Time Frame: Weeks 1 and 2 ]
  • Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment [ Time Frame: Weeks 4, 6, and 8 ]
  • Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment [ Time Frame: Week 10 ]
  • Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment [ Time Frame: Week 12 ]
  • Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment [ Time Frame: Weeks 16, 20, and 24 ]
  • Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24) [ Time Frame: Posttreatment Weeks 2, 4, 8, and 24 ]
  • For Cohort 6, Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 16 and 20 Weeks After Discontinuation of Therapy (SVR16 and SVR 20) [ Time Frame: Posttreatment Weeks 16 and 20 ]
  • Percentage of Participants With On-treatment Virologic Failure [ Time Frame: Up to Posttreatment Week 24 ]
    On-treatment 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)
  • Percentage of Participants Experiencing Viral Relapse [ Time Frame: Up to Posttreatment Week 24 ]
    Viral relapse is defined as 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: April 4, 2013)
  • Sustained virologic response after discontinuation of therapy [ Time Frame: 2,4,8, and 24 weeks after discontinuation of therapy ]
    Sustained virologic response (SVR) at 2,4,8, and 24 weeks after discontinuation of therapy (SVR 2, SVR4, SVR 8, and SVR24 defined as HCV RNA < lower limit of quantification [LLOQ] after last dose of study drug
  • Viral resistance to sofosbuvir containing regimens during and after treatment [ Time Frame: 36 Weeks ]
    To evaluate the emergence of viral resistance to Sofosbuvir containing regimens during treatment and after treatment discontinuation
  • Characterization of steady state pharmacokinetics of study drugs [ Time Frame: 12 weeks ]
    To characterize steady state pharmacokinetics of sofosbuvir containing regimens during treatment.
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 Containing Regimens for the Treatment of Chronic HCV Infection in Participants With Chronic Genotype 1, 2, 3, or 6 HCV Infection
Official Title  ICMJE A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection
Brief Summary The purpose of this study is to evaluate the antiviral efficacy, safety, tolerability of combination therapy with sofosbuvir (SOF) containing regimens for the treatment of chronic hepatitis C virus (HCV) infection.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Hepatitis C
Intervention  ICMJE
  • Drug: LDV/SOF
    Ledipasvir/sofosbuvir (LDV/SOF) (90 /400 mg) fixed-dose combination (FDC) tablet administered orally once daily
    Other Names:
    • Harvoni®
    • GS-5885/GS-7977
  • Drug: SOF
    SOF 400 mg tablet administered orally once daily
    Other Names:
    • GS-7977
    • Sovaldi®
  • Drug: RBV
    Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
  • Drug: Peg-IFN
    pegylated interferon (Peg-IFN) 180 µg administered subcutaneously once weekly
    Other Name: Pegasys®
  • Drug: GS-9669
    GS-9669 500 mg (2 × 250 mg tablet) administered orally once daily
  • Drug: VEL
    Velpatasvir (VEL) tablet(s) administered orally once daily
    Other Name: GS-5816
Study Arms  ICMJE
  • Experimental: Cohort 1,Group 1: LDV/SOF + RBV 12 wk (GT1 SOF retreatment)
    LDV/SOF + RBV for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve sustained virologic response (SVR) in a previous Gilead sofosbuvir study
    Interventions:
    • Drug: LDV/SOF
    • Drug: RBV
  • Experimental: Cohort 1,Group 2:SOF+Peg-IFN+RBV 12 wk (GT2,3 SOF retreatment)
    SOF + PEG + RBV for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
    Interventions:
    • Drug: SOF
    • Drug: RBV
    • Drug: Peg-IFN
  • Experimental: Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, liver disease)
    LDV/SOF+RBV for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
    Interventions:
    • Drug: LDV/SOF
    • Drug: RBV
  • Experimental: Cohort 2,Group 2: LDV/SOF+GS-9669 12wk (GT1 TE, liver disease)
    LDV/SOF + GS-9669 for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
    Interventions:
    • Drug: LDV/SOF
    • Drug: GS-9669
  • Experimental: Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)
    LDV/SOF for 12 weeks in treatment-naive participants with genotype 3 HCV infection
    Intervention: Drug: LDV/SOF
  • Experimental: Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)
    LDV/SOF + RBV for 12 weeks in treatment-naive participants with genotype 3 HCV infection
    Interventions:
    • Drug: LDV/SOF
    • Drug: RBV
  • Experimental: Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)
    LDV/SOF for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
    Intervention: Drug: LDV/SOF
  • Experimental: Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)
    LDV/SOF + RBV for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
    Interventions:
    • Drug: LDV/SOF
    • Drug: RBV
  • Experimental: Cohort 3,Group 1: LDV/SOF 12 wk (GT1 cirrhotic CPT B)
    LDV/SOF for 12 weeks in participants with genotype 1 HCV infection and Child-Pugh Turcotte (CPT) B cirrhosis
    Intervention: Drug: LDV/SOF
  • Experimental: Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN noncirrhotic)
    SOF+VEL (25 mg) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
    Interventions:
    • Drug: SOF
    • Drug: VEL
  • Experimental: Cohort 4,Group 2:SOF+VEL 25mg+RBV 8 wk (GT3 TN noncirrhotic)
    SOF+VEL(25 mg)+RBV for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
    Interventions:
    • Drug: SOF
    • Drug: RBV
    • Drug: VEL
  • Experimental: Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN noncirrhotic)
    SOF+VEL (100 mg) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
    Interventions:
    • Drug: SOF
    • Drug: VEL
  • Experimental: Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN noncirrhotic)
    SOF+VEL (100 mg)+RBV for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
    Interventions:
    • Drug: SOF
    • Drug: RBV
    • Drug: VEL
  • Experimental: Cohort 5,Group 1: LDV/SOF + RBV 24 wk (SOF retreatment)
    LDV/SOF+RBV for 24 weeks in participants with genotype 1, 2, 3, or 6 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
    Interventions:
    • Drug: LDV/SOF
    • Drug: RBV
  • Experimental: Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HBV coinfection)
    LDV/SOF for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
    Intervention: Drug: LDV/SOF
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: July 28, 2016)
359
Original Estimated Enrollment  ICMJE
 (submitted: April 4, 2013)
200
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Chronic genotype 1, 2, 3, or 6 HCV infection
  • Cirrhosis determination; a liver biopsy may be required
  • Screening laboratory values within defined thresholds
  • Use of two effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

  • Pregnant or nursing female or male with pregnant female partner
  • Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
  • Chronic use of systemic immunosuppressive agents
  • History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol
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 New Zealand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01826981
Other Study ID Numbers  ICMJE GS-US-337-0122
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
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: Robert H Hyland, DPhil Gilead Sciences
PRS Account Gilead Sciences
Verification Date September 2016

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