SOF Plus DCV in Treating Chinese Treatment-experienced HCV Patients

Phase 2

Completed

• Conditions: Chronic Hepatitis C Infection
• Interventions: Drug: Sofosbuvir; Drug: Daclatasvir

• Registration Number: NCT02473211
• Lead Sponsor: Humanity and Health Research Centre

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).

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-06-12
• Study First Submitted QC: 2015-06-12
• Study First Posted: 2015-06-16
• Primary Completion: 2017-12-31
• Status Verified: 2018-03
• Study Completion: 2018-03-15
• Last Update Submitted: 2018-03-16
• Last Update Posted: 2018-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Proportion of participants with sustained virologic response 12 weeks after the end of treatment (SVR12)	Post treatment Week 12	SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ) (15 IU/ml) 12 weeks following the last dose of study drug

Trial Locations

Locations (2)

Humanity and Health GI and Liver Centre; 🇨🇳 Hong Kong, Hong Kong, China

Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital; 🇨🇳 Beijing, Beijing, China