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A Phase 3, Comparative Study of Asunaprevir and Daclatasvir Combination Therapy Versus Telaprevir Therapy in Japanese HCV Subjects

Primary Purpose

Hepatitis C Virus Infection

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Daclatasvir
Asunaprevir
Ribavirin
pegIFNα-2b
Telaprevir
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C Virus Infection

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic HCV-1b infected patient
  • HCV Ribonucleic acid (RNA) > 100,000 IU/mL at screening
  • Ages 20 to 70 years (for the Naive cohort), ages 20 to 75 years (for the Relapser cohort)
  • Treatment naive subjects to Interferon (IFN) based therapy
  • Subjects who had undetectable HCV RNA at end of treatment with prior exposure to an IFN-containing regimen, but HCV RNA detectable within 24 weeks of treatment follow-up

Exclusion Criteria:

  • Patients who have;

    • Hepatocellular carcinoma
    • Co-infection with Hepatitis B virus (HBV) or Human immunodeficiency virus (HIV)
    • Severe or uncontrollable complication

Sites / Locations

  • Local Institution
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Arm 1: Daclatasvir + Asunaprevir

Arm 2: Telaprevir + pegIFNα-2b + Ribavirin

Arm 3: Daclatasvir + Asunaprevir

Arm Description

Daclatasvir 60 mg tablets by mouth once daily and Asunaprevir 200 mg capsules by mouth twice daily for 24 weeks - Naive cohort

Telaprevir 750 mg tablets by mouth three times daily, pegIFNα-2b 1.5 μg/kg solution by Subcutaneous weekly & Ribavirin 600- 1000 mg Capsules by mouth twice daily for 24 Weeks - Naive cohort

Daclatasvir 60 mg tablets by mouth once daily and Asunaprevir 200 mg capsules by mouth twice daily for 24 weeks - Relapser cohort

Outcomes

Primary Outcome Measures

Proportion of subjects with SVR12, defined as HCV RNA target detected or target not detected below LLOQ in the naive cohort
SVR12 = Sustained virologic response at post-treatment Week 12 LLOQ = Lower Limit of quantitation

Secondary Outcome Measures

Proportion of subjects with hemoglobin < 10g/dL
Proportion of subjects with rash-related dermatologic events
Proportion of subjects with HCV RNA target detected or target not detected below LLOQ in the naive cohort
EOT = End of treatment
Proportion of subjects with HCV RNA target not detected in the naive cohort
eRVR = Extended rapid virologic response
Proportion of subjects with SVR12, defined as HCV RNA target detected or target not detected below LLOQ in the relapser cohort
Proportion of subjects with HCV RNA target detected or target not detected below LLOQ in the relapser cohort
Proportion of subjects with HCV RNA target not detected in the relapser cohort
On treatment safety, as measured by the frequency of Severe adverse events (SAEs), discontinuation and dose modification/interruption due to Adverse events (AEs), Grade 3-4 abnormalities observed from clinical laboratory tests for each treatment group

Full Information

First Posted
October 29, 2012
Last Updated
September 23, 2015
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01718145
Brief Title
A Phase 3, Comparative Study of Asunaprevir and Daclatasvir Combination Therapy Versus Telaprevir Therapy in Japanese HCV Subjects
Official Title
A Phase 3, Comparative Study of Asunaprevir and Daclatasvir (DUAL) Combination Therapy Versus Telaprevir Therapy in Japanese Genotype 1b Chronic Hepatitis C IFN Eligible-naive Subjects With a Single Arm Assessment of DUAL Therapy in IFN-therapy Relapsers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2014 (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 assess the anti-viral activity of BMS-790052 and BMS-650032 combination therapy in Japanese subject. The purpose of this study is to compare the anti-viral activity of the co-administration of Asunaprevir (ASV) and Daclatasvir (DCV) to Telaprevir (TVR) included therapy in Japanese Hepatitis C virus (HCV) subjects
Detailed Description
Intervention Model: Parallel in the Naive cohort and Single group in the Relapser cohort

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
258 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Daclatasvir + Asunaprevir
Arm Type
Experimental
Arm Description
Daclatasvir 60 mg tablets by mouth once daily and Asunaprevir 200 mg capsules by mouth twice daily for 24 weeks - Naive cohort
Arm Title
Arm 2: Telaprevir + pegIFNα-2b + Ribavirin
Arm Type
Active Comparator
Arm Description
Telaprevir 750 mg tablets by mouth three times daily, pegIFNα-2b 1.5 μg/kg solution by Subcutaneous weekly & Ribavirin 600- 1000 mg Capsules by mouth twice daily for 24 Weeks - Naive cohort
Arm Title
Arm 3: Daclatasvir + Asunaprevir
Arm Type
Experimental
Arm Description
Daclatasvir 60 mg tablets by mouth once daily and Asunaprevir 200 mg capsules by mouth twice daily for 24 weeks - Relapser cohort
Intervention Type
Drug
Intervention Name(s)
Daclatasvir
Intervention Type
Drug
Intervention Name(s)
Asunaprevir
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Type
Biological
Intervention Name(s)
pegIFNα-2b
Intervention Type
Drug
Intervention Name(s)
Telaprevir
Primary Outcome Measure Information:
Title
Proportion of subjects with SVR12, defined as HCV RNA target detected or target not detected below LLOQ in the naive cohort
Description
SVR12 = Sustained virologic response at post-treatment Week 12 LLOQ = Lower Limit of quantitation
Time Frame
After 12 weeks of the last dose
Secondary Outcome Measure Information:
Title
Proportion of subjects with hemoglobin < 10g/dL
Time Frame
First 12 weeks of treatment
Title
Proportion of subjects with rash-related dermatologic events
Time Frame
First 12 weeks of treatment
Title
Proportion of subjects with HCV RNA target detected or target not detected below LLOQ in the naive cohort
Description
EOT = End of treatment
Time Frame
At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12; EOT (up to 24 weeks), post-treatment Week 4 and post-treatment Week 24
Title
Proportion of subjects with HCV RNA target not detected in the naive cohort
Description
eRVR = Extended rapid virologic response
Time Frame
At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [eRVR]; EOT (up to 24 weeks), post-treatment Week 4, post-treatment Week 12 and post-treatment Week 24
Title
Proportion of subjects with SVR12, defined as HCV RNA target detected or target not detected below LLOQ in the relapser cohort
Time Frame
At post-treatment Week 12
Title
Proportion of subjects with HCV RNA target detected or target not detected below LLOQ in the relapser cohort
Time Frame
At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12; EOT (up to 24 weeks), post-treatment Week 4 and Week 24
Title
Proportion of subjects with HCV RNA target not detected in the relapser cohort
Time Frame
At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [eRVR]; EOT (up to 24 weeks), post-treatment Week 4, post-treatment Week 12 and post-treatment Week 24
Title
On treatment safety, as measured by the frequency of Severe adverse events (SAEs), discontinuation and dose modification/interruption due to Adverse events (AEs), Grade 3-4 abnormalities observed from clinical laboratory tests for each treatment group
Time Frame
End of treatment (24 weeks) plus 7days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic HCV-1b infected patient HCV Ribonucleic acid (RNA) > 100,000 IU/mL at screening Ages 20 to 70 years (for the Naive cohort), ages 20 to 75 years (for the Relapser cohort) Treatment naive subjects to Interferon (IFN) based therapy Subjects who had undetectable HCV RNA at end of treatment with prior exposure to an IFN-containing regimen, but HCV RNA detectable within 24 weeks of treatment follow-up Exclusion Criteria: Patients who have; Hepatocellular carcinoma Co-infection with Hepatitis B virus (HBV) or Human immunodeficiency virus (HIV) Severe or uncontrollable complication
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
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
4668560
Country
Japan
Facility Name
Local Institution
City
Toyoake Shi
State/Province
Aichi
ZIP/Postal Code
4701192
Country
Japan
Facility Name
Local Institution
City
Chiba-shi
State/Province
Chiba
ZIP/Postal Code
2608677
Country
Japan
Facility Name
Local Institution
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
8108563
Country
Japan
Facility Name
Local Institution
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
8300011
Country
Japan
Facility Name
Local Institution
City
Ogaki-shi
State/Province
Gifu
ZIP/Postal Code
5038502
Country
Japan
Facility Name
Local Institution
City
Takasaki City
State/Province
Gunma
ZIP/Postal Code
3700829
Country
Japan
Facility Name
Local Institution
City
Hiroshima-shi
State/Province
Hiroshima
ZIP/Postal Code
7340037
Country
Japan
Facility Name
Local Institution
City
Obihiro-shi
State/Province
Hokkaido
ZIP/Postal Code
080-0016
Country
Japan
Facility Name
Local Institution
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
0600033
Country
Japan
Facility Name
Local Institution
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
0608648
Country
Japan
Facility Name
Local Institution
City
Takamatsu-shi
State/Province
Kagawa
ZIP/Postal Code
760-8557
Country
Japan
Facility Name
Local Institution
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
8908520
Country
Japan
Facility Name
Local Institution
City
Kawasaki-shi
State/Province
Kanagawa
ZIP/Postal Code
2138587
Country
Japan
Facility Name
Local Institution
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
2360004
Country
Japan
Facility Name
Local Institution
City
Kumamoto-shi
State/Province
Kumamoto
ZIP/Postal Code
8608556
Country
Japan
Facility Name
Local Institution
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
6028566
Country
Japan
Facility Name
Local Institution
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
9808574
Country
Japan
Facility Name
Local Institution
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
3908621
Country
Japan
Facility Name
Local Institution
City
Nagasaki-shi
State/Province
Nagasaki
ZIP/Postal Code
8528501
Country
Japan
Facility Name
Local Institution
City
Omura
State/Province
Nagasaki
ZIP/Postal Code
8568562
Country
Japan
Facility Name
Local Institution
City
Kashihara
State/Province
Nara
ZIP/Postal Code
6348522
Country
Japan
Facility Name
Local Institution
City
Yufu
State/Province
Oita
ZIP/Postal Code
8795593
Country
Japan
Facility Name
Local Institution
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
7008558
Country
Japan
Facility Name
Local Institution
City
Osaka-sayama-shi
State/Province
Osaka
ZIP/Postal Code
5898511
Country
Japan
Facility Name
Local Institution
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
5438555
Country
Japan
Facility Name
Local Institution
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
5458586
Country
Japan
Facility Name
Local Institution
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
5650871
Country
Japan
Facility Name
Local Institution
City
Suita
State/Province
Osaka
ZIP/Postal Code
5640013
Country
Japan
Facility Name
Local Institution
City
Iruma-gun
State/Province
Saitama
ZIP/Postal Code
3500495
Country
Japan
Facility Name
Local Institution
City
Izunokuni
State/Province
Shizuoka
ZIP/Postal Code
4102295
Country
Japan
Facility Name
Local Institution
City
Shimotsuke-shi
State/Province
Tochigi
ZIP/Postal Code
3290498
Country
Japan
Facility Name
Local Institution
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
1138519
Country
Japan
Facility Name
Local Institution
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
1138655
Country
Japan
Facility Name
Local Institution
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
1058470
Country
Japan
Facility Name
Local Institution
City
Musashino-shi
State/Province
Tokyo
ZIP/Postal Code
1808610
Country
Japan
Facility Name
Local Institution
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
1428666
Country
Japan
Facility Name
Local Institution
City
Yamagata-shi
State/Province
Yamagata
ZIP/Postal Code
9909585
Country
Japan
Facility Name
Local Institution
City
Chuo-shi
State/Province
Yamanashi
ZIP/Postal Code
4093898
Country
Japan
Facility Name
Local Institution
City
Fukui
ZIP/Postal Code
9188503
Country
Japan
Facility Name
Local Institution
City
Fukuoka
ZIP/Postal Code
8140180
Country
Japan
Facility Name
Local Institution
City
Fukuoka
ZIP/Postal Code
8158555
Country
Japan
Facility Name
Local Institution
City
Gifu
ZIP/Postal Code
5008513
Country
Japan
Facility Name
Local Institution
City
Kumamoto
ZIP/Postal Code
8628655
Country
Japan
Facility Name
Local Institution
City
Nagoya-shi
ZIP/Postal Code
4678602
Country
Japan
Facility Name
Local Institution
City
Nishinomiya-shi
ZIP/Postal Code
6638501
Country
Japan
Facility Name
Local Institution
City
Osaka
ZIP/Postal Code
5400006
Country
Japan
Facility Name
Local Institution
City
Saitama
ZIP/Postal Code
3380001
Country
Japan

12. IPD Sharing Statement

Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource

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A Phase 3, Comparative Study of Asunaprevir and Daclatasvir Combination Therapy Versus Telaprevir Therapy in Japanese HCV Subjects

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