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SOF Plus DCV in Treating Chinese Treatment-experienced HCV Patients

Primary Purpose

Chronic Hepatitis C Infection

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Sofosbuvir

Daclatasvir

About this trial

This is an interventional treatment trial for Chronic Hepatitis C Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients chronically infected with HCV Genotype-1b;
Documented evidence of relapse after completion of previous course of interferon-based regimen with or without ribavirin;
HCV RNA level greater than 10,000 IU/ml at screening;
Patients with compensated cirrhosis are permitted.

Exclusion Criteria:

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;
Screening ECG with clinically significant abnormalities;
Laboratory results outside of acceptable ranges at screening;
Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).

Sites / Locations

Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital
Humanity and Health GI and Liver Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SOF+DCV

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02473211

First Posted

June 12, 2015

Last Updated

March 16, 2018

Sponsor

Humanity and Health Research Centre

Collaborators

Beijing 302 Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02473211

Brief Title

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

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

January 2015 (undefined)

Primary Completion Date

December 31, 2017 (Actual)

Study Completion Date

March 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Humanity and Health Research Centre

Collaborators

Beijing 302 Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis C Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

106 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SOF+DCV

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Sofosbuvir

Other Intervention Name(s)

GS-7977

Intervention Description

Sofosbuvir 400 mg tablet administered once daily

Intervention Type

Drug

Intervention Name(s)

Daclatasvir

Other Intervention Name(s)

BMS-790052

Intervention Description

Daclatasvir 60mg tablet administered once daily

Primary Outcome Measure Information:

Title

Proportion of participants with sustained virologic response 12 weeks after the end of treatment (SVR12)

Description

SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) (15 IU/ml) 12 weeks following the last dose of study drug

Time Frame

Post treatment Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients chronically infected with HCV Genotype-1b; Documented evidence of relapse after completion of previous course of interferon-based regimen with or without ribavirin; HCV RNA level greater than 10,000 IU/ml at screening; Patients with compensated cirrhosis are permitted. Exclusion Criteria: 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; Screening ECG with clinically significant abnormalities; Laboratory results outside of acceptable ranges at screening; Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

George KK Lau, MD

Organizational Affiliation

Humanity and Health GI and Liver Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100039

Country

China

Facility Name

Humanity and Health GI and Liver Centre

City

Hong Kong

State/Province

Hong Kong

ZIP/Postal Code

00852

Country

China

12. IPD Sharing Statement

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SOF Plus DCV in Treating Chinese Treatment-experienced HCV Patients

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