Clinical trial NCT01016912: Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha-2b and Ribavirin) in Japanese Patients
Official title: A Phase 2a Study of BMS-790052 in Combination With Peginterferon Alfa-2b (PegIntron®) and Ribavirin (Rebetol®) in Japanese Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C Infection
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-11-20
Enrollment: 51
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
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 identify at least 1 dose of daclatasvir that is safe, well tolerated, and efficacious when combined with peginterferon-alfa and ribavirin for the treatment of hepatitis C virus genotype 1 in chronically infected patients who are treatment-naïve and nonresponsive to the standard of care


Eligibility criteria: Key Inclusion Criteria:

* Patients chronically infected with hepatitis C virus (HCV) genotype 1
* HCV RNA viral load ≥10\*5\* IU/mL at screening
* Naïve or nonresponsive to the current standard of care

Key Exclusion Criteria:

* Cirrhosis
* Hepatocellular carcinoma
* Coinfection with hepatitis B virus, HIV-1 or HIV-2

Primary outcomes:
measure: Percentage of Participants With Extended Rapid Virologic Response (eRVR)
timeFrame: At Weeks 4 and 12 on treatment
Secondary outcomes:
measure: Percentage of Participants With Rapid Virologic Response (RVR)
timeFrame: At Week 4 on treatment
measure: Percentage of Participants With Complete Early Virologic Response (cEVR)
timeFrame: At Week 12 on treatment
measure: Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24
timeFrame: Follow-up Weeks 4, 12, and 24
measure: Percentage of Participants With Virologic Failure
timeFrame: From on-treatment Week 1 to Follow-up Week 24
Other outcomes:
measure: Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome
timeFrame: From baseline to 30 days after last dose of study drug
measure: Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results
timeFrame: From baseline to 30 days after last dose of study drug
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: Suita-Shi
country: Japan
facility: Local Institution
state: Osaka
city: Iruma-Gun
country: Japan
facility: Local Institution
state: Saitama
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: Murakami E, Imamura M, Hayes CN, Abe H, Hiraga N, Honda Y, Ono A, Kosaka K, Kawaoka T, Tsuge M, Aikata H, Takahashi S, Miki D, Ochi H, Matsui H, Kanai A, Inaba T, McPhee F, Chayama K. Ultradeep sequencing study of chronic hepatitis C virus genotype 1 infection in patients treated with daclatasvir, peginterferon, and ribavirin. Antimicrob Agents Chemother. 2014;58(4):2105-12. doi: 10.1128/AAC.02068-13. Epub 2014 Jan 27.