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A Phase 3 Study in Combination With BMS-790052 and BMS-650032 in Japanese Hepatitis C Virus (HCV) Patients

Primary Purpose

Hepatitis C

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

BMS-790052 (Daclatasvir)

BMS-650032 (Asunaprevir)

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis C Virus Infection

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Daclatasvir + Asunaprevir

Arm Description

Outcomes

Primary Outcome Measures

Antiviral activity, as determined by the proportion of subjects with SVR24

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 lower limit of quantitation (LLOQ) target detected or not detected

Antiviral activity, as determined by the proportion of subjects who achieve HCV RNA below LLOQ, target not detected

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

Proportion of subjects with SVR24 by IL28B status [CC, CT, or TT genotype at the IL28B rs12979860 single nucleotide polymorphisms (SNP)]

Full Information

NCT ID

NCT01497834

First Posted

December 2, 2011

Last Updated

September 23, 2015

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT01497834

Brief Title

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

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee

5. 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 subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C

Keywords

Hepatitis C Virus Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

224 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Daclatasvir + Asunaprevir

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

BMS-790052 (Daclatasvir)

Intervention Description

Tablets, Oral, 60mg, Once daily, 24 weeks

Intervention Type

Drug

Intervention Name(s)

BMS-650032 (Asunaprevir)

Intervention Description

Capsules, Oral, 100mg, Twice daily, 24 weeks

Primary Outcome Measure Information:

Title

Antiviral activity, as determined by the proportion of subjects with SVR24

Description

SVR24 - sustained virologic response at follow-up Week 24 (after end of treatment)

Time Frame

After 24 weeks of the last dose

Secondary Outcome Measure Information:

Title

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

Time Frame

Weeks 1, 2, 4, 6, 8, 10 and 12; Weeks 4 and 12; End of treatment (EOT), or post treatment Week 12

Title

Antiviral activity, as determined by the proportion of subjects who achieve HCV RNA below LLOQ, target not detected

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

Title

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

Time Frame

End of treatment plus 7 days

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Local Institution

City

Nagoya-shi

State/Province

Aichi

ZIP/Postal Code

4668560

Country

Japan

Facility Name

Local Institution

City

Chiba-shi

State/Province

Chiba

ZIP/Postal Code

2608677

Country

Japan

Facility Name

Local Institution

City

Fukuoka-shi

State/Province

Fukuoka

ZIP/Postal Code

8108563

Country

Japan

Facility Name

Local Institution

City

Kurume

State/Province

Fukuoka

ZIP/Postal Code

8300011

Country

Japan

Facility Name

Local Institution

City

Ogaki-shi

State/Province

Gifu

ZIP/Postal Code

5038502

Country

Japan

Facility Name

Local Institution

City

Hiroshima-shi

State/Province

Hiroshima

ZIP/Postal Code

7340037

Country

Japan

Facility Name

Local Institution

City

Sapporo-Shi

State/Province

Hokkaido

ZIP/Postal Code

0600033

Country

Japan

Facility Name

Local Institution

City

Amagasaki-shi

State/Province

Hyogo

ZIP/Postal Code

6608511

Country

Japan

Facility Name

Local Institution

City

Kanazawa-shi

State/Province

Ishikawa

ZIP/Postal Code

9208641

Country

Japan

Facility Name

Local Institution

City

Takamatsu-shi

State/Province

Kagawa

ZIP/Postal Code

7608557

Country

Japan

Facility Name

Local Institution

City

Kagoshima-shi

State/Province

Kagoshima

ZIP/Postal Code

8908520

Country

Japan

Facility Name

Local Institution

City

Kawasaki-Shi

State/Province

Kanagawa

ZIP/Postal Code

2138587

Country

Japan

Facility Name

Local Institution

City

Sendai-Shi

State/Province

Miyagi

ZIP/Postal Code

9808574

Country

Japan

Facility Name

Local Institution

City

Okayama-shi

State/Province

Okayama

ZIP/Postal Code

7008558

Country

Japan

Facility Name

Local Institution

City

Osaka-sayama-shi

State/Province

Osaka

ZIP/Postal Code

5898511

Country

Japan

Facility Name

Local Institution

City

Osaka-shi

State/Province

Osaka

ZIP/Postal Code

5458586

Country

Japan

Facility Name

Local Institution

City

Suita-shi

State/Province

Osaka

ZIP/Postal Code

5650871

Country

Japan

Facility Name

Local Institution

City

Suita

State/Province

Osaka

ZIP/Postal Code

5640013

Country

Japan

Facility Name

Local Institution

City

Iruma-Gun

State/Province

Saitama

ZIP/Postal Code

350-0495

Country

Japan

Facility Name

Local Institution

City

Bunkyo-Ku

State/Province

Tokyo

ZIP/Postal Code

1138655

Country

Japan

Facility Name

Local Institution

City

Minato-ku

State/Province

Tokyo

ZIP/Postal Code

1058470

Country

Japan

Facility Name

Local Institution

City

Musashino-shi

State/Province

Tokyo

ZIP/Postal Code

1808610

Country

Japan

Facility Name

Local Institution

City

Shinagawa-ku

State/Province

Tokyo

ZIP/Postal Code

1428666

Country

Japan

Facility Name

Local Institution

City

Chuo-shi

State/Province

Yamanashi

ZIP/Postal Code

4093898

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

27287851

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.

Results Reference

derived

PubMed Identifier

26683763

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.

Results Reference

derived

PubMed Identifier

24604476

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.

Results Reference

derived

Links:

URL

http://www.bms.com/studyconnect/Pages/home.aspx

Description

BMS clinical trial educational resource

Learn more about this trial

A Phase 3 Study in Combination With BMS-790052 and BMS-650032 in Japanese Hepatitis C Virus (HCV) Patients

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A Phase 3 Study in Combination With BMS-790052 and BMS-650032 in Japanese Hepatitis C Virus (HCV) Patients

Hepatitis C

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial