Neutrino Regimen for Treatment-experienced HCV GT1 Patients

Overview

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

Full Title of Study: “Efficacy and Safety of Neutrino Therapy for Chronic HCV Genotype 1b Treatment-experienced Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2016

Interventions

  • 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).

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12)
    • 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.
  • Proportion of participants with adverse events leading to permanent discontinuation of study drug(s)
    • Time Frame: Baseline up to Week 24
    • Adverse events leading to permanent discontinuation of study drug(s)

Secondary Measures

  • Change in HCV RNA From Baseline to Week 12
    • Time Frame: Baseline up to Week 24
  • Proportion of participants with on-treatment virologic breakthrough and relapse
    • Time Frame: Baseline up to Week 24

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Humanity and Health Research Centre
  • Collaborator
    • Beijing 302 Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • George Lau, MD, Principal Investigator, Humanity and Health GI and Liver Centre
    • Guofeng Chen, MD, Principal Investigator, 302 Hospital

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