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Neutrino Regimen for Treatment-experienced HCV GT1 Patients

Sponsor
Humanity and Health Research Centre (Other)
Overall Status
Completed
CT.gov ID
NCT02480686
Collaborator
Beijing 302 Hospital (Other)
32
Enrollment
2
Locations
1
Arm
19
Duration (Months)
16
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate the efficacy and safety of NEUTRINO regimen in Chinese chronic HCV genotype 1b treatment-experienced patients.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Neutrino Therapy for Chronic HCV Genotype 1b Treatment-experienced Patients
Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Aug 1, 2016
Actual Study Completion Date :
Aug 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: SOF+PEG+RBV

Participants with HCV genotype 1b infection will receive Sofosbuvir (SOF) 400 mg +PEG+RBV for 12 weeks.

Drug: SOF+PEG+RBV
Sofosbuvir (SOF) 400 mg tablet is administered orally once daily; Pegylated interferon alfa-2a (PEG) 180 μg was administered once weekly by subcutaneous injection; Ribavirin (RBV) was administered as a tablet orally according to body weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
Other Names:
  • GS-7977
  • PSI-7977
  • Sovaldi®
  • Pegasys®
  • Copegus®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12) [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) [Baseline up to Week 24]

      Adverse events leading to permanent discontinuation of study drug(s)

    Secondary Outcome Measures

    1. Change in HCV RNA From Baseline to Week 12 [Baseline up to Week 24]

    2. Proportion of participants with on-treatment virologic breakthrough and relapse [Baseline up to Week 24]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Age equal to or greater than 18 years, with chronic genotype 1b infection;

    2. HCV RNA equal to or greater than 10,000 IU/mL at Screening;

    3. Cirrhosis determination;

    4. Subjects who are treatment-experienced;

    5. Screening laboratory values within defined thresholds;

    6. Use of highly effective contraception methods if female of childbearing potential or sexually active male.

    Exclusion Criteria:

    1. HIV or chronic hepatitis B virus (HBV) infection;

    2. Contraindications for PEG or RBV therapy;

    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);

    6. Chronic use of systemic immunosuppressive agents;

    7. History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.

    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 Lau, MD, Humanity and Health GI and Liver Centre
    • Principal Investigator: Guofeng Chen, MD, 302 Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Humanity and Health Research Centre
    ClinicalTrials.gov Identifier:
    NCT02480686
    Other Study ID Numbers:
    • H&H_Neutrino Therapy
    First Posted:
    Jun 24, 2015
    Last Update Posted:
    Aug 22, 2016
    Last Verified:
    Aug 1, 2016
    Additional relevant MeSH terms:
    Hepatitis C
    Hepatitis C, Chronic
    Sofosbuvir

    Study Results

    No Results Posted as of Aug 22, 2016