Clinical trial NCT01051414: An Anti-viral Combination Study With Japanese Hepatitis C Infection (HCV) Subject
Official title: A Phase 2a Study of BMS-790052 and BMS-650032 in Combination Therapy With Japanese Subjects With Genotype 1 Chronic Hepatitis C (HCV) Virus Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C Infection
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2010-01-18
Enrollment: 43
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the efficacy and safety profile of co-administration of BMS-790052 and BMS-650032 for 24 weeks treatment.


Eligibility criteria: Inclusion Criteria:

* Subjects chronically infected with HCV Genotype 1
* HCV RNA viral load of ≥ 10\*5\* IU/mL (100,000 IU/mL) at screening

Exclusion Criteria:

* Subjects with evidence of liver cirrhosis
* Evidence of HCC
* Co-infection with hepatitis B virus, HIV

Primary outcomes:
measure: Part 1: To assess safety and tolerability based on 4 weeks safety data, as measured by related serious adverse events (SAEs) and discontinuations due to related AEs
timeFrame: Week 4
measure: Part 2: To determine the proportion of subjects who achieve SVR12 (i.e., HCV RNA < 15 IU/mL at follow-up Week 12)
timeFrame: Post-treatment Week 12
Secondary outcomes:
measure: The safety of co-administration of BMS-790052 + BMS-650032 as measured by the frequency of SAEs, discontinuations due to AEs, and Grade 3 - 4 laboratory abnormalities
timeFrame: Weeks 4, 12, end of treatment and post-treatment Week 24
measure: The proportion of subjects who achieve RVR (defined as HCV RNA < 15 IU/mL
timeFrame: Week 4
measure: The proportion of subjects with extended rapid virologic response (eRVR), defined as HCV RNA < 15 IU/mL
timeFrame: at both Weeks 4 and 12
measure: The proportion of subjects who achieve SVR24 (defined as HCV RNA < 15 IU/mL
timeFrame: at follow-up Week 24
measure: Resistant variants associated with clinical failure
timeFrame: Weeks 4, 12, end of treatment and post-treatment Week 24
Other outcomes:
Locations:
city: Hiroshima City
country: Japan
facility: Local Institution
state: Hiroshima
city: Sapporo-Shi
country: Japan
facility: Local Institution
state: Hokkaido
city: Kawasaki-Shi
country: Japan
facility: Local Institution
state: Kanagawa
city: Minato-Ku
country: Japan
facility: Local Institution
state: Tokyo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Kao JH, Jensen DM, Manns MP, Jacobson I, Kumada H, Toyota J, Heo J, Yoffe B, Sievert W, Bessone F, Peng CY, Roberts SK, Lee YJ, Bhore R, Mendez P, Hughes E, Noviello S. Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis. Liver Int. 2016 Jul;36(7):954-62. doi: 10.1111/liv.13049. Epub 2016 Jan 24.
citation: Suzuki Y, Ikeda K, Suzuki F, Toyota J, Karino Y, Chayama K, Kawakami Y, Ishikawa H, Watanabe H, Hu W, Eley T, McPhee F, Hughes E, Kumada H. Dual oral therapy with daclatasvir and asunaprevir for patients with HCV genotype 1b infection and limited treatment options. J Hepatol. 2013 Apr;58(4):655-62. doi: 10.1016/j.jhep.2012.09.037. Epub 2012 Nov 23.
citation: Karino Y, Toyota J, Ikeda K, Suzuki F, Chayama K, Kawakami Y, Ishikawa H, Watanabe H, Hernandez D, Yu F, McPhee F, Kumada H. Characterization of virologic escape in hepatitis C virus genotype 1b patients treated with the direct-acting antivirals daclatasvir and asunaprevir. J Hepatol. 2013 Apr;58(4):646-54. doi: 10.1016/j.jhep.2012.11.012. Epub 2012 Nov 22.