Neutrino Regimen for Treatment-experienced HCV GT1 Patients

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

Official Title
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Efficacy and Safety of Neutrino Therapy for Chronic HCV Genotype 1b Treatment-experienced Patients

Conditions
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Chronic Hepatitis C Infection

Intervention / Treatment
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* Drug: SOF+PEG+RBV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age equal to or greater than 18 years, with chronic genotype 1b infection; HCV RNA equal to or greater than 10,000 IU/mL at Screening; Cirrhosis determination; Subjects who are treatment-experienced; Screening laboratory values within defined thresholds; Use of highly effective contraception methods if female of childbearing potential or sexually active male. Exclusion Criteria: HIV or chronic hepatitis B virus (HBV) infection; Contraindications for PEG or RBV therapy; 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); Chronic use of systemic immunosuppressive agents; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SOF+PEG+RBV<br>Participants with HCV genotype 1b infection will receive Sofosbuvir (SOF) 400 mg +PEG+RBV for 12 weeks. | Drug: SOF+PEG+RBV<br>* 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).<br>* Other names: Copegus®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12) | SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after last dose of study drug. | Post treatment Week 12 | 
| Proportion of participants with adverse events leading to permanent discontinuation of study drug(s) | Adverse events leading to permanent discontinuation of study drug(s) | Baseline up to Week 24 | 

Secondary Outcome Measures

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