Neutrino Regimen for Treatment-experienced HCV GT1 Patients

Humanity and Health Research Centre

Status and phase: Completed; Phase 4

Conditions: Chronic Hepatitis C Infection

Treatments: Drug: SOF+PEG+RBV

Study type: Interventional

Funder types: Other

Identifiers

NCT02480686

H&H_Neutrino Therapy

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

SOF+PEG+RBV

Experimental group

Description:

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

Treatment:

Drug: SOF+PEG+RBV