A Phase 3 Study in Combination With BMS-790052 and BMS-650032 in Japanese Hepatitis C Virus (HCV) Patients
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01497834
First received: December 2, 2011
Last updated: May 31, 2013
Last verified: May 2013
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Purpose
The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032 combination therapy in Japanese subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C |
Drug: BMS-790052 (Daclatasvir) Drug: BMS-650032 (Asunaprevir) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Antiviral activity, as determined by the proportion of subjects with SVR24 [ Time Frame: After 24 weeks of the last dose ] [ Designated as safety issue: No ]SVR24 - sustained virologic response at follow-up Week 24 (after end of treatment)
Secondary Outcome Measures:
- Antiviral activity, as determined by the proportion of subjects who achieve Hepatitis C virus (HCV) ribonucleic acid (RNA) below limit of quantitation (LOQ) [ Time Frame: Weeks 1, 2, 4, 6, 8, 10 and 12; Weeks 4 and 12; End of treatment (EOT), or post treatment Week 12 ] [ Designated as safety issue: No ]
- Antiviral activity, as determined by the proportion of subjects who achieve undetectable HCV RNA [ Time Frame: Weeks 1, 2, 4, 6, 8, 10 and 12; Weeks 4 and 12; EOT, or post treatment Week 12, post treatment Week 24 ] [ Designated as safety issue: No ]
- Safety, as measured by the frequency of severe adverse events (SAEs), discontinuations due to adverse events (AEs), AEs by intensity and laboratory abnormalities by toxicity grade [ Time Frame: End of treatment plus 7 days ] [ Designated as safety issue: Yes ]
- Proportion of subjects with SVR24 by IL28B status [CC, CT, or TT genotype at the IL28B rs12979860 single nucleotide polymorphisms (SNP)] [ Time Frame: Follow-up Week 24 ] [ Designated as safety issue: No ]
| Enrollment: | 224 |
| Study Start Date: | January 2012 |
| Study Completion Date: | May 2013 |
| Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Daclatasvir + Asunaprevir |
Drug: BMS-790052 (Daclatasvir)
Tablets, Oral, 60mg, Once daily, 24 weeks
Drug: BMS-650032 (Asunaprevir)
Capsules, Oral, 100mg, Twice daily, 24 weeks
|
Eligibility| Ages Eligible for Study: | 20 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497834
Locations
| Japan | |
| Local Institution | |
| Nagoya-shi, Aichi, Japan, 4668560 | |
| Local Institution | |
| Chiba-shi, Chiba, Japan, 2608677 | |
| Local Institution | |
| Fukuoka-shi, Fukuoka, Japan, 8108563 | |
| Local Institution | |
| Kurume, Fukuoka, Japan, 8300011 | |
| Local Institution | |
| Ogaki-shi, Gifu, Japan, 5038502 | |
| Local Institution | |
| Hiroshima-shi, Hiroshima, Japan, 7340037 | |
| Local Institution | |
| Sapporo-Shi, Hokkaido, Japan, 0600033 | |
| Local Institution | |
| Amagasaki-shi, Hyogo, Japan, 6608511 | |
| Local Institution | |
| Kanazawa-shi, Ishikawa, Japan, 9208641 | |
| Local Institution | |
| Takamatsu-shi, Kagawa, Japan, 7608557 | |
| Local Institution | |
| Kagoshima-shi, Kagoshima, Japan, 8908520 | |
| Local Institution | |
| Kawasaki-Shi, Kanagawa, Japan, 2138587 | |
| Local Institution | |
| Sendai-Shi, Miyagi, Japan, 9808574 | |
| Local Institution | |
| Okayama-shi, Okayama, Japan, 7008558 | |
| Local Institution | |
| Osaka-sayama-shi, Osaka, Japan, 5898511 | |
| Local Institution | |
| Osaka-shi, Osaka, Japan, 5458586 | |
| Local Institution | |
| Suita, Osaka, Japan, 5640013 | |
| Local Institution | |
| Suita-shi, Osaka, Japan, 5650871 | |
| Local Institution | |
| Iruma-Gun, Saitama, Japan, 350-0495 | |
| Local Institution | |
| Bunkyo-Ku, Tokyo, Japan, 1138655 | |
| Local Institution | |
| Minato-ku, Tokyo, Japan, 1058470 | |
| Local Institution | |
| Musashino-shi, Tokyo, Japan, 1808610 | |
| Local Institution | |
| Shinagawa-ku, Tokyo, Japan, 1428666 | |
| Local Institution | |
| Chuo-shi, Yamanashi, Japan, 4093898 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01497834 History of Changes |
| Other Study ID Numbers: | AI447-026 |
| Study First Received: | December 2, 2011 |
| Last Updated: | May 31, 2013 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Keywords provided by Bristol-Myers Squibb:
|
Hepatitis C Virus Infection |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections |
ClinicalTrials.gov processed this record on June 17, 2013