SOF Plus DCV in Treating Chinese Treatment-experienced HCV Patients

NCT ID: NCT02473211

Last Updated: 2018-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2018-03-15

Brief Summary

For those chronic hepatitis C patients, who are interferon-ineligible or intolerant, there is a burning need for the development of pan-oral interferon-free regimen. The investigators examine the efficacy and safety of sofosbuvir, a NS5B nucleotide polymerase inhibitor and daclatasvir, an NS5A replication complex inhibitor in Chinese treatment-experienced cirrhosis patients with chronic G1b infection.

Detailed Description

Chinese genotype 1b HCV treatment-experienced cirrhotic patients are recruited and treated with 12 weeks sofosbuvir 400 mg daily plus daclatasvir 60 mg daily. At baseline, liver stiffness measurement (LSM) using transient elastography (FibroScan®) is used to assess liver fibrosis and the single nucleotide polymorphism ofinterferon-λ 3 (IL-28, rs12979860, C or T) and IFLN4 (ss469415590, TT or ΔG) is determined. Serial measurement of plasma HCV RNA levels are performed with the use of the COBAS TaqMan real-time assay (Roche version 2.0), at baseline, Day 2,4 and 7, week 2,4 and 12, post-treatment week 12. The primary efficacy end point is a sustained virologic response 12 weeks after the end of treatment (SVR12).

Conditions

Chronic Hepatitis C Infection

Study Design

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

Study Groups

SOF+DCV

Participants will receive Sofosbuvir (SOF) 400 mg and Daclatasvir (DCV) 60 mg daily for 12 weeks.

Group Type: EXPERIMENTAL

Sofosbuvir

Intervention Type: DRUG

Sofosbuvir 400 mg tablet administered once daily

Daclatasvir

Intervention Type: DRUG

Daclatasvir 60mg tablet administered once daily

Interventions

Sofosbuvir

Sofosbuvir 400 mg tablet administered once daily

Intervention Type: DRUG

Daclatasvir

Daclatasvir 60mg tablet administered once daily

Intervention Type: DRUG

Other Intervention Names

GS-7977; BMS-790052

Eligibility Criteria

Inclusion Criteria

1. Patients chronically infected with HCV Genotype-1b;

2. Documented evidence of relapse after completion of previous course of interferon-based regimen with or without ribavirin;

3. HCV RNA level greater than 10,000 IU/ml at screening;

4. Patients with compensated cirrhosis are permitted.

Exclusion Criteria

1. Current or prior history: Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with treatment, assessment or compliance with the protocol; individuals currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded;

2. Screening ECG with clinically significant abnormalities;

3. Laboratory results outside of acceptable ranges at screening;

4. Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).

• Minimum Eligible Age: 18 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 KK Lau, MD

Role: PRINCIPAL_INVESTIGATOR

Humanity and Health GI and Liver Centre

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_SOF plus DCV treatment

Identifier Type: -

Identifier Source: org_study_id