Hepatitis C Virus InfectionPhase 3NCT01718145
A Phase 3, Comparative Study of Asunaprevir and Daclatasvir Combination Therapy Versus Telaprevir Therapy in Japanese HCV Subjects
A Phase 3 study testing Daclatasvir, Asunaprevir and Ribavirin in people with Hepatitis C Virus Infection, run by Bristol-Myers Squibb at 48 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 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… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Hepatitis C Virus Infection
- What is being tested?
- Daclatasvir, Asunaprevir and Ribavirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 48 sitesJapan
- Study dates
- Nov 2012to Dec 2014
- 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 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
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
48 sites in 1 country.
48 sites in 1 country
Japan48 sites
Local Institution
Bunkyo-ku, Tokyo, 1138519
Local Institution
Bunkyo-ku, Tokyo, 1138655
Local Institution
Chiba, Chiba, 2608677
Local Institution
Chuo-shi, Yamanashi, 4093898
Local Institution
Fukui-shi, Fukui, 9188503
Local Institution
Fukuoka, Fukuoka, 8108563
Local Institution
Fukuoka, Fukuoka, 8140180
Local Institution
Fukuoka, Fukuoka, 8158555
Local Institution
Gifu, Gifu, 5008513
Local Institution
Hiroshima, Hiroshima, 7340037
Local Institution
Iruma-gun, Saitama, 3500495
Local Institution
Izunokuni, Shizuoka, 4102295
Local Institution
Kagoshima, Kagoshima-ken, 8908520
Local Institution
Kashihara, Nara, 6348522
Local Institution
Kawasaki-shi, Kanagawa, 2138587
Local Institution
Kumamoto, Kumamoto, 8608556
Local Institution
Kumamoto, Kumamoto, 8628655
Local Institution
Kurume, Fukuoka, 8300011
Local Institution
Kyoto, Kyoto, 6028566
Local Institution
Matsumoto, Nagano, 3908621
Local Institution
Minato-ku, Tokyo, 1058470
Local Institution
Musashino-shi, Tokyo, 1808610
Local Institution
Nagasaki, Nagasaki, 8528501
Local Institution
Nagoya, Aichi-ken, 4668560
Local Institution
Nagoya, 4678602
Local Institution
Nishinomiya-shi, 6638501
Local Institution
Obihiro-shi, Hokkaido, 080-0016
Local Institution
Ogaki-shi, Gifu, 5038502
Local Institution
Okayama, Okayama-ken, 7008558
Local Institution
Ōmura, Nagasaki, 8568562
Local Institution
Osaka, Osaka, 5400006
Local Institution
Osaka, Osaka, 5438555
Local Institution
Osaka, Osaka, 5458586
Local Institution
Osaka-sayama-shi, Osaka, 5898511
Local Institution
Saitama, Saitama, 3380001
Local Institution
Sapporo, Hokkaido, 0600033
Local Institution
Sapporo, Hokkaido, 0608648
Local Institution
Sendai, Miyagi, 9808574
Local Institution
Shimotsuke-shi, Tochigi, 3290498
Local Institution
Shinagawa-ku, Tokyo, 1428666
Local Institution
Suita, Osaka, 5640013
Local Institution
Suita-shi, Osaka, 5650871
Local Institution
Takamatsu, Kagawa-ken, 760-8557
Local Institution
Takasaki, Gunma, 3700829
Local Institution
Toyoake Shi, Aichi-ken, 4701192
Local Institution
Yamagata, Yamagata, 9909585
Local Institution
Yokohama, Kanagawa, 2360004
Local Institution
Yufu, Oita Prefecture, 8795593
About this study
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
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
Read the detailed description
Intervention Model: Parallel in the Naive cohort and Single group in the Relapser cohort
- Conditions
- Hepatitis C Virus Infection
- Being tested
- Daclatasvir, Asunaprevir, Ribavirin, pegIFNα-2b, Telaprevir
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaclatasvirDrug
AsunaprevirDrug
RibavirinDrug
pegIFNα-2bBiological
TelaprevirDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Daclatasvir + Asunaprevir | Experimental | Daclatasvir 60 mg tablets by mouth once daily and Asunaprevir 200 mg capsules by mouth twice daily for 24 weeks
- Naive cohort Receives: Drug: Daclatasvir; Drug: Asunaprevir |
| Arm 2: Telaprevir + pegIFNα-2b + Ribavirin | Active comparator | 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 Receives: Drug: Ribavirin; Biological: pegIFNα-2b; Drug: Telaprevir |
| Arm 3: Daclatasvir + Asunaprevir | Experimental | Daclatasvir 60 mg tablets by mouth once daily and Asunaprevir 200 mg capsules by mouth twice daily for 24 weeks
- Relapser cohort Receives: Drug: Daclatasvir; Drug: Asunaprevir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with SVR12, defined as HCV RNA target detected or target not detected below LLOQ in the naive cohort
- SVR12 = Sustained virologic response at post-treatment Week 12
- LLOQ = Lower Limit of quantitation
Measured: After 12 weeks of the last dose
Secondary outcomes (8)
Proportion of subjects with hemoglobin < 10g/dL
Measured: First 12 weeks of treatment
Proportion of subjects with rash-related dermatologic events
Measured: First 12 weeks of treatment
Proportion of subjects with HCV RNA target detected or target not detected below LLOQ in the naive cohort
EOT = End of treatment
Measured: 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
Proportion of subjects with HCV RNA target not detected in the naive cohort
eRVR = Extended rapid virologic response
Measured: 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
Proportion of subjects with SVR12, defined as HCV RNA target detected or target not detected below LLOQ in the relapser cohort
Measured: At post-treatment Week 12
Proportion of subjects with HCV RNA target detected or target not detected below LLOQ in the relapser cohort
Measured: 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
Measured: 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
Measured: End of treatment (24 weeks) plus 7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C Virus InfectionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 258 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
- NCT01718145
- Sponsor's protocol ID
- AI447-031
- Status last verified
- Sep 2015
- First submitted
- 29 Oct 2012
- Last updated
- 9 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
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, 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
- ClinicalTrials.gov ID
- NCT01718145
- Acronym / sponsor ID
- AI447-031
- Conditions
- Hepatitis C Virus Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 31 Oct 2012 (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 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
Detailed description
Intervention Model: Parallel in the Naive cohort and Single group in the Relapser cohort
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Daclatasvir + Asunaprevir | Experimental | Drug: Daclatasvir, Drug: AsunaprevirDaclatasvir 60 mg tablets by mouth once daily and Asunaprevir 200 mg capsules by mouth twice daily for 24 weeks - Naive cohort |
| Arm 2: Telaprevir + pegIFNα-2b + Ribavirin | Active comparator | Drug: Ribavirin, Biological: pegIFNα-2b, Drug: TelaprevirTelaprevir 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 |
| Arm 3: Daclatasvir + Asunaprevir | Experimental | Drug: Daclatasvir, Drug: AsunaprevirDaclatasvir 60 mg tablets by mouth once daily and Asunaprevir 200 mg capsules by mouth twice daily for 24 weeks - Relapser cohort |
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 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
Key exclusion criteria (4 listed)
- Patients who have;
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 |
|---|---|---|
| Daclatasvir | Drug | Arm 1: Daclatasvir + Asunaprevir, Arm 3: Daclatasvir + Asunaprevir |
| Asunaprevir | Drug | Arm 1: Daclatasvir + Asunaprevir, Arm 3: Daclatasvir + Asunaprevir |
| Ribavirin | Drug | Arm 2: Telaprevir + pegIFNα-2b + Ribavirin |
| pegIFNα-2b | Biological | Arm 2: Telaprevir + pegIFNα-2b + Ribavirin |
| Telaprevir | Drug | Arm 2: Telaprevir + pegIFNα-2b + Ribavirin |
Primary outcome
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
* SVR12 = Sustained virologic response at post-treatment Week 12 * LLOQ = Lower Limit of quantitation
8 secondary outcomes
Proportion of subjects with hemoglobin < 10g/dL
Time frame: First 12 weeks of treatment
Proportion of subjects with rash-related dermatologic events
Time frame: First 12 weeks of treatment
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
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
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
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
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
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
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.
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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
48 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 Daclatasvir, Asunaprevir and Ribavirin in people with Hepatitis C Virus Infection, run by Bristol-Myers Squibb at 48 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 48 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.