Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care in Japanese Patients (Pegylated-interferon Alpha-2a and Ribavirin)

Phase 2

Completed

• Conditions: Hepatitis C Infection
• Interventions: Drug: Daclatasvir; Drug: Placebo; Drug: Peginterferon alfa-2a; Drug: Ribavirin

• Registration Number: NCT01017575
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to identify at least 1 dose of Daclatasvir, that when combined with peginterferon-alfa (PegIFNα) and ribavirin (RBV) for the treatment of chronically infected HCV genotype 1 treatment-naïve and non-responder to standard of care subjects is safe, well tolerated, and efficacious

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-11-19
• Study First Submitted QC: 2009-11-19
• Study First Posted: 2009-11-20
• Study Start: 2009-12
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2015-08
• Results First Submitted: 2015-08-13
• Results First Submitted QC: 2015-08-13
• Last Update Submitted: 2015-08-13
• Results First Posted: 2015-09-11
• Last Update Posted: 2015-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• Subjects chronically infected with hepatitis C virus (HCV) genotype 1
• HCV RNA viral load ≥ 10*5* IU/mL (100,000 IU/mL) at screening
• The current standard of care naïve or non-responder

Key

Exclusion Criteria

• Cirrhosis
• HCC
• Co-infection with hepatitis B virus (HBV), HIV-1 or HIV-2

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)	Daclatasvir	Treatment Naive
Arm A (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)	Ribavirin	Treatment Naive
Arm C (Placebo, plus Peginterferon alfa-2a, Ribavirin)	Placebo	Treatment Naive
Arm D (Daclatasvir, plus peginterferon alfa-2a, Ribavirin)	Daclatasvir	Non-Responder
Arm D (Daclatasvir, plus peginterferon alfa-2a, Ribavirin)	Peginterferon alfa-2a	Non-Responder
Arm D (Daclatasvir, plus peginterferon alfa-2a, Ribavirin)	Ribavirin	Non-Responder
Arm E (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)	Peginterferon alfa-2a	Non-Responder
Arm A (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)	Peginterferon alfa-2a	Treatment Naive
Arm B (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)	Daclatasvir	Treatment Naive
Arm B (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)	Peginterferon alfa-2a	Treatment Naive
Arm B (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)	Ribavirin	Treatment Naive
Arm C (Placebo, plus Peginterferon alfa-2a, Ribavirin)	Peginterferon alfa-2a	Treatment Naive
Arm C (Placebo, plus Peginterferon alfa-2a, Ribavirin)	Ribavirin	Treatment Naive
Arm E (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)	Daclatasvir	Non-Responder
Arm E (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)	Ribavirin	Non-Responder

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Extended Rapid Virologic Response (eRVR)	From Week 4 up to Week 12	eRVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA \<15 IU/mL, the lower limit of detection at both Weeks 4 and 12.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Rapid Virologic Response (RVR)	Week 4	RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA \<15 IU/mL, the lower limit of detection at Week 4.
Percentage of Participants With a Complete Early Virologic Response (cEVR)	Week 12	cEVR was defined as hepatitis C virus RNA \<15 IU/mL at Week 12.
Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24	Follow up Week 12, Follow up Week 24	SVR at Follow-up Week 12 (SVR12) and SVR at Follow-up week 24 (SVR24) was defined as hepatitis C virus (HCV) RNA \<15 IU/mL at follow-up Weeks 12 and 24.

Trial Locations

Locations (1)

Local Institution; 🇯🇵 Musashino-Shi, Tokyo, Japan