NCT02480686CompletedPhase 4
Efficacy and Safety of Neutrino Therapy for Chronic HCV Genotype 1b Treatment-experienced Patients
Humanity and Health Research Centre2 sites in 1 country32 target enrollmentStarted: January 2015Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 32
- Locations
- 2
- Primary Endpoint
- Proportion of participants with adverse events leading to permanent discontinuation of study drug(s)
Study Overview
Brief Summary
This study will evaluate the efficacy and safety of NEUTRINO regimen in Chinese chronic HCV genotype 1b treatment-experienced patients.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
SOF+PEG+RBV
Experimental
Participants with HCV genotype 1b infection will receive Sofosbuvir (SOF) 400 mg +PEG+RBV for 12 weeks.
Intervention: SOF+PEG+RBV (Drug)
Outcomes
Primary Outcomes
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)
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.
Secondary Outcomes
- 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)
Investigators
Study Sites (2)
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