Hepatitis CPhase 3NCT01497834
A Phase 3 Study in Combination With BMS-790052 and BMS-650032 in Japanese Hepatitis C Virus (HCV) Patients
A Phase 3 study testing BMS-790052 (Daclatasvir) and BMS-650032 (Asunaprevir) in people with Hepatitis C, run by Bristol-Myers Squibb at 24 sites in Japan.
Trial summary
The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032 combination therapy in Japanese subjects. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- BMS-790052 (Daclatasvir) and BMS-650032 (Asunaprevir)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 24 sitesJapan
- Study dates
- Jan 2012to Jun 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who have -
- Hepatocellular carcinoma
- Co-infection with Hepatitis B virus (HBV) or Human Immunodeficiency Virus (HIV)
- Severe or uncontrollable complication
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Japan24 sites
Local Institution
Amagasaki-shi, Hyōgo, 6608511
Local Institution
Bunkyo-Ku, Tokyo, 1138655
Local Institution
Chiba, Chiba, 2608677
Local Institution
Chuo-shi, Yamanashi, 4093898
Local Institution
Fukuoka, Fukuoka, 8108563
Local Institution
Hiroshima, Hiroshima, 7340037
Local Institution
Iruma-Gun, Saitama, 350-0495
Local Institution
Kagoshima, Kagoshima-ken, 8908520
Local Institution
Kanazawa, Ishikawa-ken, 9208641
Local Institution
Kawasaki-Shi, Kanagawa, 2138587
Local Institution
Kurume, Fukuoka, 8300011
Local Institution
Minato-ku, Tokyo, 1058470
Local Institution
Musashino-shi, Tokyo, 1808610
Local Institution
Nagoya, Aichi-ken, 4668560
Local Institution
Ogaki-shi, Gifu, 5038502
Local Institution
Okayama, Okayama-ken, 7008558
Local Institution
Osaka, Osaka, 5458586
Local Institution
Osaka-sayama-shi, Osaka, 5898511
Local Institution
Sapporo, Hokkaido, 0600033
Local Institution
Sendai, Miyagi, 9808574
Local Institution
Shinagawa-ku, Tokyo, 1428666
Local Institution
Suita, Osaka, 5640013
Local Institution
Suita-shi, Osaka, 5650871
Local Institution
Takamatsu, Kagawa-ken, 7608557
About this study
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
The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032 combination therapy in Japanese subjects.
- Conditions
- Hepatitis C
- Being tested
- BMS-790052 (Daclatasvir), BMS-650032 (Asunaprevir)
- Keywords
- Hepatitis C Virus Infection
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-790052 (Daclatasvir)Drug
Tablets, Oral, 60mg, Once daily, 24 weeks
BMS-650032 (Asunaprevir)Drug
Capsules, Oral, 100mg, Twice daily, 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Daclatasvir + Asunaprevir | Experimental | Not described Receives: Drug: BMS-790052 (Daclatasvir); Drug: BMS-650032 (Asunaprevir) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antiviral activity, as determined by the proportion of subjects with SVR24
SVR24 - sustained virologic response at follow-up Week 24 (after end of treatment)
Measured: After 24 weeks of the last dose
Secondary outcomes (4)
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
Measured: Weeks 1, 2, 4, 6, 8, 10 and 12; Weeks 4 and 12; End of treatment (EOT), or post treatment Week 12
Antiviral activity, as determined by the proportion of subjects who achieve HCV RNA below LLOQ, target not detected
Measured: Weeks 1, 2, 4, 6, 8, 10 and 12; Weeks 4 and 12; EOT, or post treatment Week 12, post treatment Week 24
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
Measured: End of treatment plus 7 days
Proportion of subjects with SVR24 by IL28B status [CC, CT, or TT genotype at the IL28B rs12979860 single nucleotide polymorphisms (SNP)]
Measured: Follow-up Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionApr 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01497834
- Sponsor's protocol ID
- AI447-026
- Status last verified
- Sep 2015
- First submitted
- 2 Dec 2011
- Last updated
- 9 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27287851Kao 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.
PubMed 26683763Kumada 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.
PubMed 24604476
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01497834
- Acronym / sponsor ID
- AI447-026
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C Virus Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 23 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032 combination therapy in Japanese subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daclatasvir + Asunaprevir | Experimental | Drug: BMS-790052 (Daclatasvir), Drug: BMS-650032 (Asunaprevir) |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Patients who have -
- Hepatocellular carcinoma
- Co-infection with Hepatitis B virus (HBV) or Human Immunodeficiency Virus (HIV)
- Severe or uncontrollable complication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-790052 (Daclatasvir)Tablets, Oral, 60mg, Once daily, 24 weeks | Drug | Daclatasvir + Asunaprevir |
| BMS-650032 (Asunaprevir)Capsules, Oral, 100mg, Twice daily, 24 weeks | Drug | Daclatasvir + Asunaprevir |
Primary outcome
Antiviral activity, as determined by the proportion of subjects with SVR24
Time frame: After 24 weeks of the last dose
SVR24 - sustained virologic response at follow-up Week 24 (after end of treatment)
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2015.
- Derived from this study: PubMed 27287851Hernandez 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.
- Derived from this study: PubMed 26683763Kao 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.
- Derived from this study: PubMed 24604476Kumada 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BMS-790052 (Daclatasvir) and BMS-650032 (Asunaprevir) in people with Hepatitis C, run by Bristol-Myers Squibb at 24 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antiviral activity, as determined by the proportion of subjects with SVR24 (time frame: After 24 weeks of the last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01497834, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2015.