A Phase 3, Comparative Study of Asunaprevir and Daclatasvir Combination Therapy Versus Telaprevir Therapy in Japanese HCV Subjects
This study is ongoing, but not recruiting participants.
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01718145
First received: October 29, 2012
Last updated: April 12, 2013
Last verified: April 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 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
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C Virus Infection |
Drug: Daclatasvir Drug: Asunaprevir Drug: Ribavirin Biological: pegIFNα-2b Drug: Telaprevir |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Proportion of subjects with SVR12, defined as HCV RNA target detected or target not detected below LLOQ in the naive cohort [ Time Frame: After 12 weeks of the last dose ] [ Designated as safety issue: No ]
- SVR12 = Sustained virologic response at post-treatment Week 12
- LLOQ = Lower Limit of quantitation
Secondary Outcome Measures:
- Proportion of subjects with hemoglobin < 10g/dL [ Time Frame: First 12 weeks of treatment ] [ Designated as safety issue: Yes ]
- Proportion of subjects with rash-related dermatologic events [ Time Frame: First 12 weeks of treatment ] [ Designated as safety issue: Yes ]
- Proportion of subjects with HCV RNA target detected or target not detected below LLOQ in the naive cohort [ Time Frame: 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 ] [ Designated as safety issue: No ]EOT = End of treatment
- Proportion of subjects with HCV RNA target not detected in the naive cohort [ Time Frame: 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 ] [ Designated as safety issue: No ]eRVR = Extended rapid virologic response
- Proportion of subjects with SVR12, defined as HCV RNA target detected or target not detected below LLOQ in the relapser cohort [ Time Frame: At post-treatment Week 12 ] [ Designated as safety issue: No ]
- Proportion of subjects with HCV RNA target detected or target not detected below LLOQ in the relapser cohort [ Time Frame: 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 ] [ Designated as safety issue: No ]
- Proportion of subjects with HCV RNA target not detected in the relapser cohort [ Time Frame: 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 ] [ Designated as safety issue: No ]
- 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 [ Time Frame: End of treatment (24 weeks) plus 7days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 224 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1: Daclatasvir + Asunaprevir
Daclatasvir 60 mg tablets by mouth once daily and Asunaprevir 200 mg capsules by mouth twice daily for 24 weeks - Naive cohort |
Drug: Daclatasvir Drug: Asunaprevir |
|
Active Comparator: Arm 2: Telaprevir + pegIFNα-2b + Ribavirin
Telaprevir 750 mg tablets by mouth three times daily, pegIFNα-2b 1.5 μg/kg solution by Subcutaneous weekly & Ribavirin 600- 1000 mg Capsules by mouth twice daily for 24 Weeks - Naive cohort |
Drug: Ribavirin Biological: pegIFNα-2b Drug: Telaprevir |
|
Experimental: Arm 3: Daclatasvir + Asunaprevir
Daclatasvir 60 mg tablets by mouth once daily and Asunaprevir 200 mg capsules by mouth twice daily for 24 weeks - Relapser cohort |
Drug: Daclatasvir Drug: Asunaprevir |
Detailed Description:
Intervention Model: Parallel in the Naive cohort and Single group in the Relapser cohort
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 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01718145
Locations
| Japan | |
| Local Institution | |
| Nagoya-shi, Aichi, Japan, 4668560 | |
| Local Institution | |
| Toyoake-shi, Aichi, Japan, 4701192 | |
| Local Institution | |
| Chiba-Shi, Chiba, Japan, 2608677 | |
| Local Institution | |
| Fukuoka-shi, Fukuoka, Japan, 8108563 | |
| Local Institution | |
| Kurume-shi, Fukuoka, Japan, 8390863 | |
| Local Institution | |
| Ogaki-shi, Gifu, Japan, 5038502 | |
| Local Institution | |
| Takasaki City, Gunma, Japan, 3700829 | |
| Local Institution | |
| Hiroshima-shi, Hiroshima, Japan, 7348511 | |
| Local Institution | |
| Obihiro-Shi, Hokkaido, Japan, 080-0016 | |
| Local Institution | |
| Sapporo-Shi, Hokkaido, Japan, 0600033 | |
| Local Institution | |
| Sapporo-Shi, Hokkaido, Japan, 0608648 | |
| Local Institution | |
| Takamatsu-shi, Kagawa, Japan, 7608557 | |
| Local Institution | |
| Kagoshima-shi, Kagoshima, Japan, 8908520 | |
| Local Institution | |
| Yokohama-shi, Kanagawa, Japan, 2360004 | |
| Local Institution | |
| Kumamoto-Shi, Kumamoto, Japan, 8608556 | |
| Local Institution | |
| Kyoto-Shi, Kyoto, Japan, 6028566 | |
| Local Institution | |
| Sendai-Shi, Miyagi, Japan, 9808574 | |
| Local Institution | |
| Matsumoto City, Nagano, Japan, 390-0802 | |
| Local Institution | |
| Nagasaki-shi, Nagasaki, Japan, 8528501 | |
| Local Institution | |
| Omura, Nagasaki, Japan, 8568562 | |
| Local Institution | |
| Kashihara, Nara, Japan, 6348522 | |
| Local Institution | |
| Yufu, Oita, Japan, 8795593 | |
| Local Institution | |
| Okayama-shi, Okayama, Japan, 7008558 | |
| Local Institution | |
| Osaka-sayama-shi, Osaka, Japan, 5898511 | |
| Local Institution | |
| Osaka-shi, Osaka, Japan, 5438555 | |
| 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, 3500495 | |
| Local Institution | |
| Izunokuni, Shizuoka, Japan, 4102295 | |
| Local Institution | |
| Shimotsuke-Shi, Tochigi, Japan, 3290498 | |
| Local Institution | |
| Bunkyo-Ku, Tokyo, Japan, 1138519 | |
| 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 | |
| Yamagata-shi, Yamagata, Japan, 990-21 | |
| Local Institution | |
| Chuo-shi, Yamanashi, Japan, 4093898 | |
| Local Institution | |
| Fukui, Japan, 9188503 | |
| Local Institution | |
| Fukuoka, Japan, 8140180 | |
| Local Institution | |
| Fukuoka, Japan, 8158555 | |
| Local Institution | |
| Gifu, Japan, 5008513 | |
| Local Institution | |
| Kumamoto, Japan, 8628655 | |
| Local Institution | |
| Nagoya-Shi, Japan, 4678602 | |
| Local Institution | |
| Nishinomiya-Shi, Japan, 6638501 | |
| Local Institution | |
| Osaka, Japan, 5400006 | |
| Local Institution | |
| Saitama, Japan, 3380001 | |
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: | NCT01718145 History of Changes |
| Other Study ID Numbers: | AI447-031 |
| Study First Received: | October 29, 2012 |
| Last Updated: | April 12, 2013 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Virus Diseases Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections |
RNA Virus Infections Flaviviridae Infections Ribavirin Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013