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

Primary Purpose

Hepatitis C Infection

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
BMS-790052
BMS-790052
Placebo
Peginterferon alfa-2b
Ribavirin
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C Infection

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Patients chronically infected with hepatitis C virus (HCV) genotype 1
  • HCV RNA viral load ≥10*5* IU/mL at screening
  • Naïve or nonresponsive to the current standard of care

Key Exclusion Criteria:

  • Cirrhosis
  • Hepatocellular carcinoma
  • Coinfection with hepatitis B virus, HIV-1 or HIV-2

Sites / Locations

  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

Arm A (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)

Arm B (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)

Arm C (Placebo, plus Peginterferon alfa-2b, Ribavirin)

Arm D (BMS-790052, plus peginterferon alfa-2b, Ribavirin)

Arm E (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)

Arm Description

Treatment Naive

Treatment Naive

Treatment Naive

Non-Responder

Non-Responder

Outcomes

Primary Outcome Measures

Percentage of Participants With Extended Rapid Virologic Response (eRVR)
eRVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at both Weeks 4 and 12. HCV RNA levels were measured by Tobas TaqMan HCV Auto from the central laboratory.

Secondary Outcome Measures

Percentage of Participants With Rapid Virologic Response (RVR)
RVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at Week 4. HCV RNA levels were measured by CobasTaqMan HCV Auto from the central laboratory .
Percentage of Participants With Complete Early Virologic Response (cEVR)
cEVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at Week 12 on treatment. HCV RNA levels were measured by Cobas TaqMan HCV Auto from the central laboratory
Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24
SVR at follow-up Week 4 (SVR4), follow-up Week 12 (SVR12), and follow-up Week 24 (SVR24) is defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at each of these timepoints. HCV RNA levels were measured by Cobas TaqMan HCV Auto from the central laboratory .
Percentage of Participants With Virologic Failure
Virologic failure is defined by the following 6 categories: 1.Virologic breakthrough, defined as confirmed >1 log10 increase in hepatitis C virus (HCV) RNA over nadir or confirmed HCV RNA ≥limit of quantitation (LOQ) after confirmed undetectable HCV RNA while on treatment. 2. <1 log10 decrease in HCV RNA from baseline at Week 4 of treatment. 3. Failure to achieve early virologic response, defined as <2 log10 decrease in HCV RNA from baseline at Week 12 of treatment. 4. Detectable HCV RNA at Week 12, and HCV RNA ≥LOQ at Week 24 of treatment. 5. Detectable HCV RNA at end of treatment (including early discontinuation). 6 Relapse, defined as detectable HCV RNA during follow-up after undetectable HCV RNA levels at end of treatment.

Full Information

First Posted
November 19, 2009
Last Updated
September 23, 2015
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01016912
Brief Title
Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha-2b and Ribavirin) in Japanese Patients
Official Title
A Phase 2a Study of BMS-790052 in Combination With Peginterferon Alfa-2b (PegIntron®) and Ribavirin (Rebetol®) in Japanese Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to identify at least 1 dose of daclatasvir that is safe, well tolerated, and efficacious when combined with peginterferon-alfa and ribavirin for the treatment of hepatitis C virus genotype 1 in chronically infected patients who are treatment-naïve and nonresponsive to the standard of care

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)
Arm Type
Experimental
Arm Description
Treatment Naive
Arm Title
Arm B (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)
Arm Type
Experimental
Arm Description
Treatment Naive
Arm Title
Arm C (Placebo, plus Peginterferon alfa-2b, Ribavirin)
Arm Type
Placebo Comparator
Arm Description
Treatment Naive
Arm Title
Arm D (BMS-790052, plus peginterferon alfa-2b, Ribavirin)
Arm Type
Experimental
Arm Description
Non-Responder
Arm Title
Arm E (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)
Arm Type
Experimental
Arm Description
Non-Responder
Intervention Type
Drug
Intervention Name(s)
BMS-790052
Intervention Description
Tablets, Oral, 10 mg, daily, 24-48 weeks
Intervention Type
Drug
Intervention Name(s)
BMS-790052
Intervention Description
Tablets, Oral, 60 mg, daily, 24-48 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets, Oral, 0 mg, daily, 48 weeks
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa-2b
Other Intervention Name(s)
PegIntron®
Intervention Description
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
Rebetol®
Intervention Description
Capsules, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Primary Outcome Measure Information:
Title
Percentage of Participants With Extended Rapid Virologic Response (eRVR)
Description
eRVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at both Weeks 4 and 12. HCV RNA levels were measured by Tobas TaqMan HCV Auto from the central laboratory.
Time Frame
At Weeks 4 and 12 on treatment
Secondary Outcome Measure Information:
Title
Percentage of Participants With Rapid Virologic Response (RVR)
Description
RVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at Week 4. HCV RNA levels were measured by CobasTaqMan HCV Auto from the central laboratory .
Time Frame
At Week 4 on treatment
Title
Percentage of Participants With Complete Early Virologic Response (cEVR)
Description
cEVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at Week 12 on treatment. HCV RNA levels were measured by Cobas TaqMan HCV Auto from the central laboratory
Time Frame
At Week 12 on treatment
Title
Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24
Description
SVR at follow-up Week 4 (SVR4), follow-up Week 12 (SVR12), and follow-up Week 24 (SVR24) is defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at each of these timepoints. HCV RNA levels were measured by Cobas TaqMan HCV Auto from the central laboratory .
Time Frame
Follow-up Weeks 4, 12, and 24
Title
Percentage of Participants With Virologic Failure
Description
Virologic failure is defined by the following 6 categories: 1.Virologic breakthrough, defined as confirmed >1 log10 increase in hepatitis C virus (HCV) RNA over nadir or confirmed HCV RNA ≥limit of quantitation (LOQ) after confirmed undetectable HCV RNA while on treatment. 2. <1 log10 decrease in HCV RNA from baseline at Week 4 of treatment. 3. Failure to achieve early virologic response, defined as <2 log10 decrease in HCV RNA from baseline at Week 12 of treatment. 4. Detectable HCV RNA at Week 12, and HCV RNA ≥LOQ at Week 24 of treatment. 5. Detectable HCV RNA at end of treatment (including early discontinuation). 6 Relapse, defined as detectable HCV RNA during follow-up after undetectable HCV RNA levels at end of treatment.
Time Frame
From on-treatment Week 1 to Follow-up Week 24
Other Pre-specified Outcome Measures:
Title
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome
Description
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. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug.
Time Frame
From baseline to 30 days after last dose of study drug
Title
Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results
Description
Clinically significant marked abnormalities in laboratory test results graded by the Division of AIDS grading table, 2004. Hemoglobin: Grade 3= <7.0 to 8.9 g/dL, Grade 4= <7.0 g/dL. Lymphocytes: Grade 3= 350-499 cells/mm^3, Grade 4= <350 cells/mm^3. Neutrophils: Grade 3= 500-999 cells/mm^3, Grade 4= <500 cells/mm^3. White blood cells (WBC): Grade 3= 1000-1499 cells/mm^3, Grade 4= <1000 cells/mm^3. Alanine aminotransferase (ALT): Grade 3= 5.1-10*upper limit of normal (ULN), Grade 4= >10.0*ULN. Aspartate aminotransferase (AST): Grade 3= 5.1-10*ULN, Grade 4= >10.0*ULN. Total bilirubin: Grade 3= 2.6-5*ULN, Grade 4= >5.0*ULN.
Time Frame
From baseline to 30 days after last dose of study drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Patients chronically infected with hepatitis C virus (HCV) genotype 1 HCV RNA viral load ≥10*5* IU/mL at screening Naïve or nonresponsive to the current standard of care Key Exclusion Criteria: Cirrhosis Hepatocellular carcinoma Coinfection with hepatitis B virus, HIV-1 or HIV-2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Hiroshima City
State/Province
Hiroshima
ZIP/Postal Code
734-0037
Country
Japan
Facility Name
Local Institution
City
Sapporo-Shi
State/Province
Hokkaido
ZIP/Postal Code
060-0033
Country
Japan
Facility Name
Local Institution
City
Kawasaki-Shi
State/Province
Kanagawa
ZIP/Postal Code
2138587
Country
Japan
Facility Name
Local Institution
City
Suita-Shi
State/Province
Osaka
ZIP/Postal Code
5650871
Country
Japan
Facility Name
Local Institution
City
Iruma-Gun
State/Province
Saitama
ZIP/Postal Code
3500495
Country
Japan
Facility Name
Local Institution
City
Minato-Ku
State/Province
Tokyo
ZIP/Postal Code
105-0001
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
24468783
Citation
Murakami E, Imamura M, Hayes CN, Abe H, Hiraga N, Honda Y, Ono A, Kosaka K, Kawaoka T, Tsuge M, Aikata H, Takahashi S, Miki D, Ochi H, Matsui H, Kanai A, Inaba T, McPhee F, Chayama K. Ultradeep sequencing study of chronic hepatitis C virus genotype 1 infection in patients treated with daclatasvir, peginterferon, and ribavirin. Antimicrob Agents Chemother. 2014;58(4):2105-12. doi: 10.1128/AAC.02068-13. Epub 2014 Jan 27.
Results Reference
derived

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

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