Neutrino Regimen for Treatment-experienced HCV GT1 Patients

NCT ID: NCT02480686

Last Updated: 2016-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-08-31

Brief Summary

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

Conditions

Chronic Hepatitis C Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SOF+PEG+RBV

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

Group Type: EXPERIMENTAL

SOF+PEG+RBV

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

Other Intervention Names

GS-7977; PSI-7977; Sovaldi®; Pegasys®; Copegus®

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing 302 Hospital

OTHER

Sponsor Role: collaborator

Humanity and Health Research Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George Lau, MD

Role: PRINCIPAL_INVESTIGATOR

Humanity and Health GI and Liver Centre

Guofeng Chen, MD

Role: PRINCIPAL_INVESTIGATOR

302 Hospital

Locations

Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital

Beijing, Beijing Municipality, China

Humanity and Health GI and Liver Centre

Hong Kong, Hong Kong, China

Countries

China

Other Identifiers

H&H_Neutrino Therapy

Identifier Type: -

Identifier Source: org_study_id