A Phase 3, Comparative Study of Asunaprevir and Daclatasvir Combination Therapy Versus Telaprevir Therapy in Japanese HCV Subjects

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT01718145

Collaborator

(none)

258

Enrollment

Locations

Arms

Duration (Months)

5.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Hepatitis C Virus Infection	Drug: Daclatasvir Drug: Asunaprevir Drug: Ribavirin Biological: pegIFNα-2b Drug: Telaprevir	Phase 3

Detailed Description

Intervention Model: Parallel in the Naive cohort and Single group in the Relapser cohort

Study Design

Study Type:

Interventional

Actual Enrollment :

258 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Nov 1, 2012

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Proportion of subjects with SVR12, defined as HCV RNA target detected or target not detected below LLOQ in the naive cohort [After 12 weeks of the last dose]
SVR12 = Sustained virologic response at post-treatment Week 12 LLOQ = Lower Limit of quantitation

Secondary Outcome Measures

Proportion of subjects with hemoglobin < 10g/dL [First 12 weeks of treatment]
Proportion of subjects with rash-related dermatologic events [First 12 weeks of treatment]
Proportion of subjects with HCV RNA target detected or target not detected below LLOQ in the naive cohort [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]
EOT = End of treatment
Proportion of subjects with HCV RNA target not detected in the naive cohort [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]
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 [At post-treatment Week 12]
Proportion of subjects with HCV RNA target detected or target not detected below LLOQ in the relapser cohort [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]
Proportion of subjects with HCV RNA target not detected in the relapser cohort [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]
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 [End of treatment (24 weeks) plus 7days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Nagoya-shi	Aichi	Japan	4668560
2	Local Institution	Toyoake Shi	Aichi	Japan	4701192
3	Local Institution	Chiba-shi	Chiba	Japan	2608677
4	Local Institution	Fukuoka-shi	Fukuoka	Japan	8108563
5	Local Institution	Kurume	Fukuoka	Japan	8300011
6	Local Institution	Ogaki-shi	Gifu	Japan	5038502
7	Local Institution	Takasaki City	Gunma	Japan	3700829
8	Local Institution	Hiroshima-shi	Hiroshima	Japan	7340037
9	Local Institution	Obihiro-shi	Hokkaido	Japan	080-0016
10	Local Institution	Sapporo-shi	Hokkaido	Japan	0600033
11	Local Institution	Sapporo-shi	Hokkaido	Japan	0608648
12	Local Institution	Takamatsu-shi	Kagawa	Japan	760-8557
13	Local Institution	Kagoshima-shi	Kagoshima	Japan	8908520
14	Local Institution	Kawasaki-shi	Kanagawa	Japan	2138587
15	Local Institution	Yokohama-shi	Kanagawa	Japan	2360004
16	Local Institution	Kumamoto-shi	Kumamoto	Japan	8608556
17	Local Institution	Kyoto-shi	Kyoto	Japan	6028566
18	Local Institution	Sendai-shi	Miyagi	Japan	9808574
19	Local Institution	Matsumoto	Nagano	Japan	3908621
20	Local Institution	Nagasaki-shi	Nagasaki	Japan	8528501
21	Local Institution	Omura	Nagasaki	Japan	8568562
22	Local Institution	Kashihara	Nara	Japan	6348522
23	Local Institution	Yufu	Oita	Japan	8795593
24	Local Institution	Okayama-shi	Okayama	Japan	7008558
25	Local Institution	Osaka-sayama-shi	Osaka	Japan	5898511
26	Local Institution	Osaka-shi	Osaka	Japan	5438555
27	Local Institution	Osaka-shi	Osaka	Japan	5458586
28	Local Institution	Suita-shi	Osaka	Japan	5650871
29	Local Institution	Suita	Osaka	Japan	5640013
30	Local Institution	Iruma-gun	Saitama	Japan	3500495
31	Local Institution	Izunokuni	Shizuoka	Japan	4102295
32	Local Institution	Shimotsuke-shi	Tochigi	Japan	3290498
33	Local Institution	Bunkyo-ku	Tokyo	Japan	1138519
34	Local Institution	Bunkyo-ku	Tokyo	Japan	1138655
35	Local Institution	Minato-ku	Tokyo	Japan	1058470
36	Local Institution	Musashino-shi	Tokyo	Japan	1808610
37	Local Institution	Shinagawa-ku	Tokyo	Japan	1428666
38	Local Institution	Yamagata-shi	Yamagata	Japan	9909585
39	Local Institution	Chuo-shi	Yamanashi	Japan	4093898
40	Local Institution	Fukui		Japan	9188503
41	Local Institution	Fukuoka		Japan	8140180
42	Local Institution	Fukuoka		Japan	8158555
43	Local Institution	Gifu		Japan	5008513
44	Local Institution	Kumamoto		Japan	8628655
45	Local Institution	Nagoya-shi		Japan	4678602
46	Local Institution	Nishinomiya-shi		Japan	6638501
47	Local Institution	Osaka		Japan	5400006
48	Local Institution	Saitama		Japan	3380001