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

August 13, 2015 updated by: Bristol-Myers Squibb

A Phase 2a Study of Daclatasvir in Combination With Peginterferon Alfa-2a(Pegasys®) and Ribavirin (Copegus®) in Japanese Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Chiba
      • Chiba-Shi, Chiba, Japan
        • Local Institution
    • Fukuoka
      • Kurume-Shi, Fukuoka, Japan, 8300011
        • Local Institution
    • Okayama
      • Okayama-Shi, Okayama, Japan, 7008558
        • Local Institution
    • Osaka
      • Osaka-Shi, Osaka, Japan, 5438555
        • Local Institution
      • Osaka-Shi, Osaka, Japan, 545-8586
        • Local Institution
    • Tokyo
      • Musashino-Shi, Tokyo, Japan, 180-0023
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm A (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)
Treatment Naive
Drug: Daclatasvir
Tablets, Oral, 10 mg, daily, 24-48 weeks
Drug: Daclatasvir
Tablets, Oral, 60 mg, daily, 24-48 weeks
Drug: Peginterferon alfa-2a
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Other Names:
  • Pegasys®
Drug: Ribavirin
Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Other Names:
  • Copegus®
EXPERIMENTAL: Arm B (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)
Treatment Naive
Drug: Daclatasvir
Tablets, Oral, 10 mg, daily, 24-48 weeks
Drug: Daclatasvir
Tablets, Oral, 60 mg, daily, 24-48 weeks
Drug: Peginterferon alfa-2a
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Other Names:
  • Pegasys®
Drug: Ribavirin
Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Other Names:
  • Copegus®
PLACEBO_COMPARATOR: Arm C (Placebo, plus Peginterferon alfa-2a, Ribavirin)
Treatment Naive
Drug: Peginterferon alfa-2a
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Other Names:
  • Pegasys®
Drug: Ribavirin
Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Other Names:
  • Copegus®
Drug: Placebo
Tablets, Oral, 0 mg, daily, 48 weeks
EXPERIMENTAL: Arm D (Daclatasvir, plus peginterferon alfa-2a, Ribavirin)
Non-Responder
Drug: Daclatasvir
Tablets, Oral, 10 mg, daily, 24-48 weeks
Drug: Daclatasvir
Tablets, Oral, 60 mg, daily, 24-48 weeks
Drug: Peginterferon alfa-2a
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Other Names:
  • Pegasys®
Drug: Ribavirin
Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Other Names:
  • Copegus®
EXPERIMENTAL: Arm E (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)
Non-Responder
Drug: Daclatasvir
Tablets, Oral, 10 mg, daily, 24-48 weeks
Drug: Daclatasvir
Tablets, Oral, 60 mg, daily, 24-48 weeks
Drug: Peginterferon alfa-2a
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Other Names:
  • Pegasys®
Drug: Ribavirin
Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Other Names:
  • Copegus®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Extended Rapid Virologic Response (eRVR)
Time Frame: 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.
From Week 4 up to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Rapid Virologic Response (RVR)
Time Frame: 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.
Week 4
Percentage of Participants With a Complete Early Virologic Response (cEVR)
Time Frame: Week 12
cEVR was defined as hepatitis C virus RNA <15 IU/mL at Week 12.
Week 12
Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24
Time Frame: 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.
Follow up Week 12, Follow up Week 24

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died.
Time Frame: From Baseline up to 30 days after last dose of study drug
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
From Baseline up to 30 days after last dose of study drug
Number of Participants With Grade 3 to 4 Laboratory Abnormalities
Time Frame: From screening up to Week 12 (treatment period)
Clinically significant change in marked laboratory abnormalities (Grade 3 to 4) included: Aspartate aminotransferase (AST)- Grade 3 as >5.0 to 10.0*Upper Limit of Normal (ULN), Grade 4 as >10.0*ULN; Hemoglobin- Grade 3 as 7.0 to 8.9 g/dL, Grade 4 as <7.0 g/dL; Neutrophils- Grade 3 as 0.5 to 0.749*10^9/L, Grade 4 as <0.5*10^9/L; Lymphocytes- Grade 3 as 0.35 to 0.499*10^9/L, Grade 4 as <0.35*10^9/L; Platelets- Grade 3 as 25000 to 49999*10^9/L, Grade 4 as <25000 10^9/L; white blood cells (WBC) - Grade 3 as 1000 to 1499*10^9/L, Grade 4 as <1000*10^9/L and Lipase- Grade 3 as 3.1-5.0*ULN, Grade 4 as >5.0*ULN.
From screening up to Week 12 (treatment period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (ACTUAL)

October 1, 2011

Study Completion (ACTUAL)

October 1, 2011

Study Registration Dates

First Submitted

November 19, 2009

First Submitted That Met QC Criteria

November 19, 2009

First Posted (ESTIMATE)

November 20, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

September 11, 2015

Last Update Submitted That Met QC Criteria

August 13, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI444-022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis C Infection

Clinical Trials on Daclatasvir

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe