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SOF Plus DCV in Treating Chinese Treatment-experienced HCV Patients

Sponsor
Humanity and Health Research Centre (Other)
Overall Status
Completed
CT.gov ID
NCT02473211
Collaborator
Beijing 302 Hospital (Other)
106
Enrollment
2
Locations
1
Arm
38.4
Duration (Months)
53
Patients Per Site
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

For those chronic hepatitis C patients, who are interferon-ineligible or intolerant, there is a burning need for the development of pan-oral interferon-free regimen. The investigators examine the efficacy and safety of sofosbuvir, a NS5B nucleotide polymerase inhibitor and daclatasvir, an NS5A replication complex inhibitor in Chinese treatment-experienced cirrhosis patients with chronic G1b infection.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Detailed Description

Chinese genotype 1b HCV treatment-experienced cirrhotic patients are recruited and treated with 12 weeks sofosbuvir 400 mg daily plus daclatasvir 60 mg daily. At baseline, liver stiffness measurement (LSM) using transient elastography (FibroScan®) is used to assess liver fibrosis and the single nucleotide polymorphism ofinterferon-λ 3 (IL-28, rs12979860, C or T) and IFLN4 (ss469415590, TT or ΔG) is determined. Serial measurement of plasma HCV RNA levels are performed with the use of the COBAS TaqMan real-time assay (Roche version 2.0), at baseline, Day 2,4 and 7, week 2,4 and 12, post-treatment week 12. The primary efficacy end point is a sustained virologic response 12 weeks after the end of treatment (SVR12).

Study Design

Study Type:
Interventional
Actual Enrollment :
106 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Sofosbuvir Plus Daclatasvir in Chinese Treatment-experienced Patients With Chronic Genotype 1b HCV Infection
Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Dec 31, 2017
Actual Study Completion Date :
Mar 15, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: SOF+DCV

Participants will receive Sofosbuvir (SOF) 400 mg and Daclatasvir (DCV) 60 mg daily for 12 weeks.

Drug: Sofosbuvir
Sofosbuvir 400 mg tablet administered once daily
Other Names:
  • GS-7977

    • Drug: Daclatasvir
    Daclatasvir 60mg tablet administered once daily
    Other Names:
  • BMS-790052

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of participants with sustained virologic response 12 weeks after the end of treatment (SVR12) [Post treatment Week 12]

      SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) (15 IU/ml) 12 weeks following the last dose of study drug

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patients chronically infected with HCV Genotype-1b;

    2. Documented evidence of relapse after completion of previous course of interferon-based regimen with or without ribavirin;

    3. HCV RNA level greater than 10,000 IU/ml at screening;

    4. Patients with compensated cirrhosis are permitted.

    Exclusion Criteria:

    1. Current or prior history: Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with treatment, assessment or compliance with the protocol; individuals currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded;

    2. Screening ECG with clinically significant abnormalities;

    3. Laboratory results outside of acceptable ranges at screening;

    4. Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital Beijing Beijing China 100039
    2 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Humanity and Health Research Centre
    ClinicalTrials.gov Identifier:
    NCT02473211
    Other Study ID Numbers:
    • H&H_SOF plus DCV treatment
    First Posted:
    Jun 16, 2015
    Last Update Posted:
    Mar 19, 2018
    Last Verified:
    Mar 1, 2018
    Additional relevant MeSH terms:
    Infections
    Hepatitis C
    Hepatitis C, Chronic
    Sofosbuvir

    Study Results

    No Results Posted as of Mar 19, 2018