SOF Plus DCV in Treating Chinese Treatment-experienced HCV Patients

Chronic Hepatitis C Infection Clinical Trial

Official title:

Efficacy and Safety of Sofosbuvir Plus Daclatasvir in Chinese Treatment-experienced Patients With Chronic Genotype 1b HCV Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02473211
• Other study ID #: H&H_SOF plus DCV treatment
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 12, 2015
• Last updated: March 16, 2018
• Start date: January 2015
• Est. completion date: March 15, 2018

Study information

• Verified date: March 2018
• Source: Humanity and Health Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: March 15, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Hepatitis C Infection
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Infection

Intervention

Drug:
• Sofosbuvir
Sofosbuvir 400 mg tablet administered once daily
• Daclatasvir
Daclatasvir 60mg tablet administered once daily

Locations

Country	Name	City	State
China	Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital	Beijing	Beijing
China	Humanity and Health GI and Liver Centre	Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Humanity and Health Research Centre	Beijing 302 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with sustained virologic response 12 weeks after the end of treatment (SVR12)	SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) (15 IU/ml) 12 weeks following the last dose of study drug	Post treatment Week 12