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UNITY 3: A Japanese Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 in Subjects With Genotype 1 Chronic Hepatitis C

Primary Purpose

Hepatitis C Virus Infection

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Daclatasvir
Asunaprevir
DCV 3DAA
Placebo for DCV 3DAA
Placebo for Daclatasvir
Placebo for Asunaprevir
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 - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Males and females, ≥ 20 years of age
  • Subjects chronically infected with HCV GT-1
  • HCV RNA viral load of ≥ 100,000 IU/mL

Exclusion Criteria:

  • 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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  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Arm 1: DCV 3DAA + Placebo for DCV/Placebo for ASV

Arm 2: DCV/ASV + Placebo for DCV 3DAA

DCV 3DAA

Arm Description

DCV 3DAA tablet orally twice daily for 12 weeks + Placebo for DCV tablet orally once daily and Placebo for ASV capsule orally twice daily for 24 weeks (Double blind)

Daclatasvir 60 mg tablet orally once daily and Asunaprevir 100 mg capsule orally twice daily for 24 weeks + Placebo for DCV 3DAA tablet orally twice daily for 12 weeks (Double blind)

DCV 3DAA (open label) Tablet orally twice daily for 12 weeks

Outcomes

Primary Outcome Measures

Proportion of treated subjects who achieve SVR12 in treatment-naive non-cirrhotic subjects treated with DCV/ASV/BMS-791325, defined as HCV RNA < LOQ target detected or target not detected (LOQ TD/TND) at post-treatment follow-up Week 12

Secondary Outcome Measures

The proportion of treatment-naive subjects who achieve SVR12 with DCV/ASV/BMS-791325 or DCV/ASV
The proportion of Interferon (IFN) experienced subjects who achieve SVR12 with DCV/ASV/BMS-791325
The proportion of subjects who achieve HCV RNA < LOQ TD/TND at each of the following Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT; post-treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24)
The proportion of subjects who achieve HCV RNA < LOQ TND at each of the following Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT; post-treatment Weeks 4, 8, 12 and 24
On-treatment safety as measured by the frequency of Serious Adverse Event (SAEs), discontinuations due to Adverse Event (AEs), and selected Grade 3 - 4 laboratory abnormalities
based on the US National Institutes of Health Division of AIDs (DAIDS) criteria
The proportion of subjects with anemia defined as Hb < 10 g/dL on-treatment who had Hb ≥ 10 g/dL at baseline
The proportion of subjects in each cohort who achieve SVR12 associated with HCV genotype subtype 1a vs 1b
The proportion of subjects in each cohort who achieve SVR12 associated with IL28B Single Nucleotide Polymorphisms (SNP) status
The proportion of cirrhotic and non-cirrhotic subjects who achieve SVR12
On-treatment safety of non-cirrhotic vs cirrhotic subjects, as measured by the frequency of SAEs, discontinuations due to AEs, and selected Grade 3 - 4 laboratory abnormalities on DAIDS criteria

Full Information

First Posted
April 10, 2014
Last Updated
September 16, 2015
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT02123654
Brief Title
UNITY 3: A Japanese Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 in Subjects With Genotype 1 Chronic Hepatitis C
Official Title
A Japanese Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Treatment-Naive and IFN Experienced Subjects With Genotype 1 Chronic Hepatitis C
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
August 2015 (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 demonstrate that the proportion of treatment-naive non-cirrhotic subjects with Genotype (GT)-1b treated with Daclatasvir (DCV)/Asunaprevir (ASV)/BMS-791325 who achieve Sustained Virologic response (SVR12), defined as Hepatitis C virus (HCV) RNA < LOQ target detected or target not detected (LOQ TD/TND) at follow-up Week 12, is significantly higher than SVR12 of current Standard of Care (SOC).
Detailed Description
Limit of Quantitation (LOQ) Ribonucleic acid (RNA) End of Treatment (EOT) Triple Direct Acting Antivirals (3DAA)

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
ParticipantInvestigator
Allocation
Randomized
Enrollment
297 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: DCV 3DAA + Placebo for DCV/Placebo for ASV
Arm Type
Experimental
Arm Description
DCV 3DAA tablet orally twice daily for 12 weeks + Placebo for DCV tablet orally once daily and Placebo for ASV capsule orally twice daily for 24 weeks (Double blind)
Arm Title
Arm 2: DCV/ASV + Placebo for DCV 3DAA
Arm Type
Active Comparator
Arm Description
Daclatasvir 60 mg tablet orally once daily and Asunaprevir 100 mg capsule orally twice daily for 24 weeks + Placebo for DCV 3DAA tablet orally twice daily for 12 weeks (Double blind)
Arm Title
DCV 3DAA
Arm Type
Experimental
Arm Description
DCV 3DAA (open label) Tablet orally twice daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Daclatasvir
Intervention Type
Drug
Intervention Name(s)
Asunaprevir
Intervention Type
Drug
Intervention Name(s)
DCV 3DAA
Other Intervention Name(s)
Daclatasvir 30 mg /Asunaprevir 200 mg /BMS-791325 75 mg fixed dose combination
Intervention Type
Other
Intervention Name(s)
Placebo for DCV 3DAA
Intervention Type
Other
Intervention Name(s)
Placebo for Daclatasvir
Intervention Type
Other
Intervention Name(s)
Placebo for Asunaprevir
Primary Outcome Measure Information:
Title
Proportion of treated subjects who achieve SVR12 in treatment-naive non-cirrhotic subjects treated with DCV/ASV/BMS-791325, defined as HCV RNA < LOQ target detected or target not detected (LOQ TD/TND) at post-treatment follow-up Week 12
Time Frame
After 12 weeks of the last dose
Secondary Outcome Measure Information:
Title
The proportion of treatment-naive subjects who achieve SVR12 with DCV/ASV/BMS-791325 or DCV/ASV
Time Frame
Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24
Title
The proportion of Interferon (IFN) experienced subjects who achieve SVR12 with DCV/ASV/BMS-791325
Time Frame
Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24
Title
The proportion of subjects who achieve HCV RNA < LOQ TD/TND at each of the following Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT; post-treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24)
Time Frame
Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24
Title
The proportion of subjects who achieve HCV RNA < LOQ TND at each of the following Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT; post-treatment Weeks 4, 8, 12 and 24
Time Frame
Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24
Title
On-treatment safety as measured by the frequency of Serious Adverse Event (SAEs), discontinuations due to Adverse Event (AEs), and selected Grade 3 - 4 laboratory abnormalities
Description
based on the US National Institutes of Health Division of AIDs (DAIDS) criteria
Time Frame
Approximately 48 weeks
Title
The proportion of subjects with anemia defined as Hb < 10 g/dL on-treatment who had Hb ≥ 10 g/dL at baseline
Time Frame
Approximately 48 weeks
Title
The proportion of subjects in each cohort who achieve SVR12 associated with HCV genotype subtype 1a vs 1b
Time Frame
Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24
Title
The proportion of subjects in each cohort who achieve SVR12 associated with IL28B Single Nucleotide Polymorphisms (SNP) status
Time Frame
Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24
Title
The proportion of cirrhotic and non-cirrhotic subjects who achieve SVR12
Time Frame
Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24
Title
On-treatment safety of non-cirrhotic vs cirrhotic subjects, as measured by the frequency of SAEs, discontinuations due to AEs, and selected Grade 3 - 4 laboratory abnormalities on DAIDS criteria
Time Frame
Approximately 48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Males and females, ≥ 20 years of age Subjects chronically infected with HCV GT-1 HCV RNA viral load of ≥ 100,000 IU/mL Exclusion Criteria: 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
466-8560
Country
Japan
Facility Name
Local Institution
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
4678602
Country
Japan
Facility Name
Local Institution
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
8108563
Country
Japan
Facility Name
Local Institution
City
Kurume-shi
State/Province
Fukuoka
ZIP/Postal Code
8300011
Country
Japan
Facility Name
Local Institution
City
Gifu-shi
State/Province
Gifu
ZIP/Postal Code
5008513
Country
Japan
Facility Name
Local Institution
City
Ogaki-shi
State/Province
Gifu
ZIP/Postal Code
5038502
Country
Japan
Facility Name
Local Institution
City
Takasaki
State/Province
Gunma
ZIP/Postal Code
3700829
Country
Japan
Facility Name
Local Institution
City
Hiroshima-Shi
State/Province
Hiroshima
ZIP/Postal Code
7348551
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
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
6500047
Country
Japan
Facility Name
Local Institution
City
Kanazawa-shi
State/Province
Ishikawa
ZIP/Postal Code
9208641
Country
Japan
Facility Name
Local Institution
City
Takamatsu-shi
State/Province
Kagawa
ZIP/Postal Code
7608557
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
State/Province
Kanagawa
ZIP/Postal Code
2320024
Country
Japan
Facility Name
Local Institution
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
6028566
Country
Japan
Facility Name
Local Institution
City
Kashihara
State/Province
Nara
ZIP/Postal Code
6348522
Country
Japan
Facility Name
Local Institution
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
7008558
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
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
Shinjuku-Ku
State/Province
Tokyo
ZIP/Postal Code
1608582
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
Kumamoto
ZIP/Postal Code
8628655
Country
Japan
Facility Name
Local Institution
City
Miyazaki
ZIP/Postal Code
8800003
Country
Japan
Facility Name
Local Institution
City
Nishinomiya-shi
ZIP/Postal Code
6638501
Country
Japan
Facility Name
Local Institution
City
Saga
ZIP/Postal Code
8408571
Country
Japan

12. IPD Sharing Statement

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

Learn more about this trial

UNITY 3: A Japanese Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 in Subjects With Genotype 1 Chronic Hepatitis C

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