Clinical trial NCT01497834: A Phase 3 Study in Combination With BMS-790052 and BMS-650032 in Japanese Hepatitis C Virus (HCV) Patients
Official title: A Phase 3 Japanese Study of BMS-790052 Plus BMS-650032 Combination Therapy in Chronic Hepatitis C Genotype 1b Infected Subjects Who Are Non Response to Interferon Plus Ribavirin and Interferon Based Therapy Ineligible Naive/Intolerant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C
Keywords: Hepatitis C Virus Infection
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2011-12-23
Enrollment: 224
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: The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032 combination therapy in Japanese subjects.


Eligibility criteria: Inclusion Criteria:

* Chronic HCV-1b infected patient
* HCV RNA viral load of ≥ 100,000 IU/mL at screening
* Ages 20 to 75 years
* Non-responder to Interferon plus Ribavirin therapy
* Patient who has been excluded from interferon/ribavirin therapy or intolerant for Interferon/Ribavirin therapy

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: Antiviral activity, as determined by the proportion of subjects with SVR24
timeFrame: After 24 weeks of the last dose
Secondary outcomes:
measure: Antiviral activity, as determined by the proportion of subjects who achieve Hepatitis C virus (HCV) ribonucleic acid (RNA) below lower limit of quantitation (LLOQ) target detected or not detected
timeFrame: Weeks 1, 2, 4, 6, 8, 10 and 12; Weeks 4 and 12; End of treatment (EOT), or post treatment Week 12
measure: Antiviral activity, as determined by the proportion of subjects who achieve HCV RNA below LLOQ, target not detected
timeFrame: Weeks 1, 2, 4, 6, 8, 10 and 12; Weeks 4 and 12; EOT, or post treatment Week 12, post treatment Week 24
measure: Safety, as measured by the frequency of serious adverse events (SAEs), discontinuations due to adverse events (AEs), AEs by intensity and laboratory abnormalities by toxicity grade
timeFrame: End of treatment plus 7 days
measure: Proportion of subjects with SVR24 by IL28B status [CC, CT, or TT genotype at the IL28B rs12979860 single nucleotide polymorphisms (SNP)]
timeFrame: Follow-up Week 24
Other outcomes:
Locations:
city: Nagoya-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: Hiroshima-shi
country: Japan
facility: Local Institution
state: Hiroshima
city: Sapporo-Shi
country: Japan
facility: Local Institution
state: Hokkaido
city: Amagasaki-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: Sendai-Shi
country: Japan
facility: Local Institution
state: Miyagi
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: 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: Shinagawa-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Chuo-shi
country: Japan
facility: Local Institution
state: Yamanashi
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Hernandez D, Yu F, Huang X, Kirov S, Pant S, McPhee F. Impact of Pre-existing NS5A-L31 or -Y93H Minor Variants on Response Rates in Patients Infected with HCV Genotype-1b Treated with Daclatasvir/Asunaprevir. Adv Ther. 2016 Jul;33(7):1169-79. doi: 10.1007/s12325-016-0354-1. Epub 2016 Jun 10.
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: Kumada H, Suzuki Y, Ikeda K, Toyota J, Karino Y, Chayama K, Kawakami Y, Ido A, Yamamoto K, Takaguchi K, Izumi N, Koike K, Takehara T, Kawada N, Sata M, Miyagoshi H, Eley T, McPhee F, Damokosh A, Ishikawa H, Hughes E. Daclatasvir plus asunaprevir for chronic HCV genotype 1b infection. Hepatology. 2014 Jun;59(6):2083-91. doi: 10.1002/hep.27113. Epub 2014 Apr 1.