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Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT3 Infected Patients

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: NCT02576314
Recruitment Status : Completed
First Posted : October 15, 2015
Last Update Posted : March 19, 2018
Sponsor:
Collaborator:
Beijing 302 Hospital
Information provided by (Responsible Party):
Humanity and Health Research Centre

Tracking Information
First Submitted Date  ICMJE October 12, 2015
First Posted Date  ICMJE October 15, 2015
Last Update Posted Date March 19, 2018
Study Start Date  ICMJE May 2015
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2015)
  • Proportion of participants with sustained virologic response 12 weeks (SVR12) after discontinuation of therapy [ Time Frame: Post treatment Week 12 ]
    SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ < 25 IU/mL) 12 weeks following the last dose of study medication
  • Incidence of adverse events leading to permanent discontinuation of study drug [ Time Frame: Baseline up to Week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2015)
  • Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment [ Time Frame: Baseline up to Week 12 ]
  • HCV RNA levels and change during and after treatment [ Time Frame: Baseline up to Week 12 ]
  • Treatment adherence [ Time Frame: Baseline to Week 12 ]
    To evaluate the proportion of patients adherent to therapy (both on-treatment adherence and treatment discontinuation)
  • Change in health related quality of life [ Time Frame: Baseline to Week 24 ]
    To evaluate the change in health-related quality of life during treatment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT3 Infected Patients
Official Title  ICMJE Efficacy and Safety Study of Sofosbuvir Containing Regimens in Subjects With Chronic Hepatitis C Virus Genotype 3 Infection
Brief Summary The purpose of this study is to assess the safety, tolerability, and efficacy of Sofosbuvir containing regimens in treatment-naive or treatment-experienced patients with HCV genotype 3 infection.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Hepatitis C Infection
Intervention  ICMJE
  • Drug: sofosbuvir and daclatasvir
    Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Daclatasvir (DCV) 60 mg tablet administered orally once daily.
    Other Names:
    • Sovaldi®
    • PSI-7977
    • GS-7977
    • Daklinza®
    • BMS-790052
  • Drug: ledipasvir/sofosbuvir

    Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally.

    once daily;

    Other Names:
    • Harvoni®
    • GS-5885
    • GS-7977
    • PSI-7977
Study Arms  ICMJE
  • Active Comparator: Sofosbuvir and Daclatasvir
    Participants will receive Sofosbuvir (SOF) 400 mg and Daclatasvir (DCV) 60 mg daily for 12 weeks.
    Intervention: Drug: sofosbuvir and daclatasvir
  • Active Comparator: Ledipasvir/sofosbuvir
    Participants will receive Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet daily for 12 weeks.
    Intervention: Drug: ledipasvir/sofosbuvir
Publications * Not Provided

*   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: March 16, 2018)
48
Original Estimated Enrollment  ICMJE
 (submitted: October 13, 2015)
60
Actual Study Completion Date  ICMJE March 15, 2018
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age equal to or greater than 18 years, with chronic genotype 3 HCV infection;
  • Documented HCV treatment-naïve or treatment-experienced subjects who failed previous PEG+RBV regimen;
  • HCV RNA > 10,000 IU/mL at Screening;
  • Screening laboratory values within defined thresholds;
  • Negative pregnancy test at baseline (females of childbearing potential only);
  • Use of two effective contraception methods if female of childbearing potential or sexually active male.

Exclusion Criteria:

  • Pregnant or nursing female;
  • HIV infection or HBV infection (HBcAb and HBsAg positive);
  • Hematologic or biochemical parameters at Screening outside the protocol-specified requirements;
  • Active or recent history (≤ 1 year) of drug or alcohol abuse;
  • Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers).
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
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02576314
Other Study ID Numbers  ICMJE H&H_HCV G3 Study
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Humanity and Health Research Centre
Study Sponsor  ICMJE Humanity and Health Research Centre
Collaborators  ICMJE Beijing 302 Hospital
Investigators  ICMJE
Principal Investigator: George Lau, MD Humanity and Health GI and Liver Centre
PRS Account Humanity and Health Research Centre
Verification Date March 2018

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