Clinical trial NCT02473211: SOF Plus DCV in Treating Chinese Treatment-experienced HCV Patients
Official title: Efficacy and Safety of Sofosbuvir Plus Daclatasvir in Chinese Treatment-experienced Patients With Chronic Genotype 1b HCV Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Hepatitis C Infection
Lead sponsor: Humanity and Health Research Centre
Sponsor class: OTHER
Collaborators: name: Beijing 302 Hospital
First posted: 2015-06-16
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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).

Primary outcomes:
measure: Proportion of participants with sustained virologic response 12 weeks after the end of treatment (SVR12)
timeFrame: Post treatment Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital
state: Beijing
city: Hong Kong
country: China
facility: Humanity and Health GI and Liver Centre
state: Hong Kong
Study officials:
affiliation: Humanity and Health GI and Liver Centre
name: George KK Lau, MD
role: PRINCIPAL_INVESTIGATOR
References: