Clinical trial NCT02123654: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C Virus Infection
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-04-25
Enrollment: 297
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: 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
timeFrame: After 12 weeks of the last dose
Secondary outcomes:
measure: The proportion of treatment-naive subjects who achieve SVR12 with DCV/ASV/BMS-791325 or DCV/ASV
timeFrame: Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24
measure: The proportion of Interferon (IFN) experienced subjects who achieve SVR12 with DCV/ASV/BMS-791325
timeFrame: Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24
measure: 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)
timeFrame: Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24
measure: 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
timeFrame: Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24
measure: 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
timeFrame: Approximately 48 weeks
measure: The proportion of subjects with anemia defined as Hb < 10 g/dL on-treatment who had Hb ≥ 10 g/dL at baseline
timeFrame: Approximately 48 weeks
measure: The proportion of subjects in each cohort who achieve SVR12 associated with HCV genotype subtype 1a vs 1b
timeFrame: Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24
measure: The proportion of subjects in each cohort who achieve SVR12 associated with IL28B Single Nucleotide Polymorphisms (SNP) status
timeFrame: Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24
measure: The proportion of cirrhotic and non-cirrhotic subjects who achieve SVR12
timeFrame: Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24
measure: 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
timeFrame: Approximately 48 weeks
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
facility: Local Institution
state: Aichi
city: Nagoya-shi
country: Japan
facility: Local Institution
state: Aichi
city: Fukuoka-shi
country: Japan
facility: Local Institution
state: Fukuoka
city: Kurume-shi
country: Japan
facility: Local Institution
state: Fukuoka
city: Gifu-shi
country: Japan
facility: Local Institution
state: Gifu
city: Ogaki-shi
country: Japan
facility: Local Institution
state: Gifu
city: Takasaki
country: Japan
facility: Local Institution
state: Gunma
city: Hiroshima-Shi
country: Japan
facility: Local Institution
state: Hiroshima
city: Sapporo-shi
country: Japan
facility: Local Institution
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Local Institution
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Local Institution
state: Hyogo
city: Kanazawa-shi
country: Japan
facility: Local Institution
state: Ishikawa
city: Takamatsu-shi
country: Japan
facility: Local Institution
state: Kagawa
city: Kagoshima-shi
country: Japan
facility: Local Institution
state: Kagoshima
city: Kawasaki-shi
country: Japan
facility: Local Institution
state: Kanagawa
city: Yokohama
country: Japan
facility: Local Institution
state: Kanagawa
city: Kyoto-shi
country: Japan
facility: Local Institution
state: Kyoto
city: Kashihara
country: Japan
facility: Local Institution
state: Nara
city: Okayama-shi
country: Japan
facility: Local Institution
state: Okayama
city: Osaka-shi
country: Japan
facility: Local Institution
state: Osaka
city: Osaka-shi
country: Japan
facility: Local Institution
state: Osaka
city: Suita-shi
country: Japan
facility: Local Institution
state: Osaka
city: Suita
country: Japan
facility: Local Institution
state: Osaka
city: Iruma-gun
country: Japan
facility: Local Institution
state: Saitama
city: Bunkyo-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Minato-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Musashino-shi
country: Japan
facility: Local Institution
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Local Institution
state: Tokyo
city: Yamagata-shi
country: Japan
facility: Local Institution
state: Yamagata
city: Chuo-shi
country: Japan
facility: Local Institution
state: Yamanashi
city: Fukui
country: Japan
facility: Local Institution
city: Kumamoto
country: Japan
facility: Local Institution
city: Miyazaki
country: Japan
facility: Local Institution
city: Nishinomiya-shi
country: Japan
facility: Local Institution
city: Saga
country: Japan
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: