ClinicalTrials.gov
ClinicalTrials.gov Menu

Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT2 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: NCT02482077
Recruitment Status : Completed
First Posted : June 25, 2015
Last Update Posted : March 19, 2018
Sponsor:
Collaborator:
Beijing 302 Hospital
Information provided by (Responsible Party):
Humanity and Health Research Centre

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 genotypes 2 infection.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Infection Drug: SOF+RBV Drug: SOF+DCV Drug: LDV/SOF Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety Study of Sofosbuvir Containing Regimens in Subjects With Chronic Hepatitis C Virus Genotype 2 Infection
Study Start Date : January 2015
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : March 15, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir
U.S. FDA Resources

Arm Intervention/treatment
Experimental: SOF+RBV 8 wk
Participants will receive SOF+RBV for 8 weeks.
Drug: SOF+RBV
Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
Other Names:
  • GS-7977
  • PSI-7977
  • Sovaldi®
  • Copegus®
Experimental: SOF+RBV 12 wk
Participants will receive SOF+RBV for 12 weeks.
Drug: SOF+RBV
Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
Other Names:
  • GS-7977
  • PSI-7977
  • Sovaldi®
  • Copegus®
Experimental: SOF+DCV 8 wk
Participants will receive SOF+DCV for 8 weeks.
Drug: SOF+DCV
Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Daclatasvir (DCV) 60mg tablet administered once daily.
Other Names:
  • GS-7977
  • PSI-7977
  • Sovaldi®
  • BMS-790052
  • Daklinza®
Experimental: SOF+DCV 12 wk
Participants will receive SOF+DCV for 12 weeks.
Drug: SOF+DCV
Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Daclatasvir (DCV) 60mg tablet administered once daily.
Other Names:
  • GS-7977
  • PSI-7977
  • Sovaldi®
  • BMS-790052
  • Daklinza®
Experimental: LDV/SOF 8 wk
Participants will receive LDV/SOF for 8 weeks.
Drug: LDV/SOF
Ledipasvir 90 mg /Sofosbuvir 400 mg (LDV/SOF) FDC tablet administered orally once daily
Other Names:
  • GS-7977/GS-5885
  • Harvoni®
Experimental: LDV/SOF 12 wk
Participants will receive LDV/SOF for 12 weeks.
Drug: LDV/SOF
Ledipasvir 90 mg /Sofosbuvir 400 mg (LDV/SOF) FDC tablet administered orally once daily
Other Names:
  • GS-7977/GS-5885
  • Harvoni®



Primary Outcome Measures :
  1. Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy [ Time Frame: Post treatment Week 12 ]
    SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after last dose of study drug.

  2. Proportion of participants with adverse events leading to permanent discontinuation of study drug(s) [ Time Frame: Baseline up to Week 24 ]

Secondary Outcome Measures :
  1. Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment [ Time Frame: Baseline up to Week 24 ]
  2. HCV RNA levels and change during and after treatment. [ Time Frame: Baseline up to Week 24 ]
  3. Proportion of participants with on-treatment virologic breakthrough and relapse [ Time Frame: Baseline up to Week 24 ]
    Viral breakthrough is defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) during treatment, but did not achieve a sustained virologic response (SVR). Viral relapse is defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) within 4 weeks of end of treatment, but did not achieve an SVR.



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

Inclusion Criteria:

  1. Age equal to or greater than 18 years, with chronic genotype 2 HCV infection;
  2. Documented HCV treatment-naïve or treatment-experienced subjects who failed previous PEG+RBV regimen;
  3. HCV RNA > 10,000 IU/mL at Screening;
  4. Screening laboratory values within defined thresholds
  5. Use of two effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

  1. Pregnant or nursing female or male with pregnant female partner;
  2. HIV or chronic hepatitis B virus (HBV) infection;
  3. Hematologic or biochemical parameters at Screening outside the protocol-specified requirements;
  4. Active or recent history (≤ 1 year) of drug or alcohol abuse;
  5. Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers).

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): NCT02482077


Locations
China, Beijing
Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital
Beijing, Beijing, China, 100039
China, Hong Kong
Humanity and Health GI and Liver Centre
Hong Kong, Hong Kong, China, 00852
Sponsors and Collaborators
Humanity and Health Research Centre
Beijing 302 Hospital
Investigators
Principal Investigator: George KK Lau, MD Humanity and Health GI and Liver Centre

Responsible Party: Humanity and Health Research Centre
ClinicalTrials.gov Identifier: NCT02482077     History of Changes
Other Study ID Numbers: H&H_HCV G2 Study
First Posted: June 25, 2015    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018

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