Clinical trial NCT01718145: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C Virus Infection
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2012-10-31
Enrollment: 258
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
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 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

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

Primary outcomes:
measure: Proportion of subjects with SVR12, defined as HCV RNA target detected or target not detected below LLOQ in the naive cohort
timeFrame: After 12 weeks of the last dose
Secondary outcomes:
measure: Proportion of subjects with hemoglobin < 10g/dL
timeFrame: First 12 weeks of treatment
measure: Proportion of subjects with rash-related dermatologic events
timeFrame: First 12 weeks of treatment
measure: Proportion of subjects with HCV RNA target detected or target not detected below LLOQ in the naive cohort
timeFrame: 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
measure: Proportion of subjects with HCV RNA target not detected in the naive cohort
timeFrame: 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
measure: Proportion of subjects with SVR12, defined as HCV RNA target detected or target not detected below LLOQ in the relapser cohort
timeFrame: At post-treatment Week 12
measure: Proportion of subjects with HCV RNA target detected or target not detected below LLOQ in the relapser cohort
timeFrame: 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
measure: Proportion of subjects with HCV RNA target not detected in the relapser cohort
timeFrame: 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
measure: 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
timeFrame: End of treatment (24 weeks) plus 7days
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
facility: Local Institution
state: Aichi
city: Toyoake Shi
country: Japan
facility: Local Institution
state: Aichi
city: Chiba-shi
country: Japan
facility: Local Institution
state: Chiba
city: Fukuoka-shi
country: Japan
facility: Local Institution
state: Fukuoka
city: Kurume
country: Japan
facility: Local Institution
state: Fukuoka
city: Ogaki-shi
country: Japan
facility: Local Institution
state: Gifu
city: Takasaki City
country: Japan
facility: Local Institution
state: Gunma
city: Hiroshima-shi
country: Japan
facility: Local Institution
state: Hiroshima
city: Obihiro-shi
country: Japan
facility: Local Institution
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Local Institution
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Local Institution
state: Hokkaido
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-shi
country: Japan
facility: Local Institution
state: Kanagawa
city: Kumamoto-shi
country: Japan
facility: Local Institution
state: Kumamoto
city: Kyoto-shi
country: Japan
facility: Local Institution
state: Kyoto
city: Sendai-shi
country: Japan
facility: Local Institution
state: Miyagi
city: Matsumoto
country: Japan
facility: Local Institution
state: Nagano
city: Nagasaki-shi
country: Japan
facility: Local Institution
state: Nagasaki
city: Omura
country: Japan
facility: Local Institution
state: Nagasaki
city: Kashihara
country: Japan
facility: Local Institution
state: Nara
city: Yufu
country: Japan
facility: Local Institution
state: Oita
city: Okayama-shi
country: Japan
facility: Local Institution
state: Okayama
city: Osaka-sayama-shi
country: Japan
facility: Local Institution
state: Osaka
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: Izunokuni
country: Japan
facility: Local Institution
state: Shizuoka
city: Shimotsuke-shi
country: Japan
facility: Local Institution
state: Tochigi
city: Bunkyo-ku
country: Japan
facility: Local Institution
state: Tokyo
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: Shinagawa-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: Fukuoka
country: Japan
facility: Local Institution
city: Fukuoka
country: Japan
facility: Local Institution
city: Gifu
country: Japan
facility: Local Institution
city: Kumamoto
country: Japan
facility: Local Institution
city: Nagoya-shi
country: Japan
facility: Local Institution
city: Nishinomiya-shi
country: Japan
facility: Local Institution
city: Osaka
country: Japan
facility: Local Institution
city: Saitama
country: Japan
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: