Hepatitis C InfectionPhase 2NCT01016912

Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha-2b and Ribavirin) in Japanese Patients

A Phase 2 study testing BMS-790052, Peginterferon alfa-2b and Ribavirin in people with Hepatitis C Infection, run by Bristol-Myers Squibb at 6 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to identify at least 1 dose of daclatasvir that is safe, well tolerated, and efficacious when combined with peginterferon-alfa and ribavirin for the treatment of hepatitis C virus genotype 1 in chronically infected patients who are treatment-naïve and nonresponsive to the standard of care Read more about this study

Who is it for?: Ages 20 to 70 years
Conditions the study is for: Hepatitis C Infection
What is being tested?: BMS-790052, Peginterferon alfa-2b and Ribavirin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 51 participants
Where: 6 sitesJapan
Study dates: Dec 2009to Sep 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients chronically infected with hepatitis C virus (HCV) genotype 1
HCV RNA viral load ≥10*5* IU/mL at screening
Naïve or nonresponsive to the current standard of care

Who cannot join

Cirrhosis
Hepatocellular carcinoma
Coinfection with hepatitis B virus, HIV-1 or HIV-2

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Japan6 sites

Local Institution
Hiroshima, Hiroshima, 734-0037
Local Institution
Iruma-Gun, Saitama, 3500495
Local Institution
Kawasaki-Shi, Kanagawa, 2138587
Local Institution
Minato-Ku, Tokyo, 105-0001
Local Institution
Sapporo, Hokkaido, 060-0033
Local Institution
Suita-Shi, Osaka, 5650871

Other trials in Japan

About this study

Official title: A Phase 2a Study of BMS-790052 in Combination With Peginterferon Alfa-2b (PegIntron®) and Ribavirin (Rebetol®) in Japanese Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

Conditions: Hepatitis C Infection
Being tested: BMS-790052, Placebo, Peginterferon alfa-2b, Ribavirin
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-790052Drug
Tablets, Oral, 10 mg, daily, 24-48 weeks
BMS-790052Drug
Tablets, Oral, 60 mg, daily, 24-48 weeks
PlaceboDrug
Tablets, Oral, 0 mg, daily, 48 weeks
Peginterferon alfa-2bDrug
Also called PegIntron®
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
RibavirinDrug
Also called Rebetol®
Capsules, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks

Study groups in NCT01016912
Study group	Role	What they receive
Arm A (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)	Experimental	Treatment Naive Receives: Drug: BMS-790052; Drug: Peginterferon alfa-2b; Drug: Ribavirin
Arm B (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)	Experimental	Treatment Naive Receives: Drug: BMS-790052; Drug: Peginterferon alfa-2b; Drug: Ribavirin
Arm C (Placebo, plus Peginterferon alfa-2b, Ribavirin)	Placebo comparator	Treatment Naive Receives: Drug: Placebo; Drug: Peginterferon alfa-2b; Drug: Ribavirin
Arm D (BMS-790052, plus peginterferon alfa-2b, Ribavirin)	Experimental	Non-Responder Receives: Drug: BMS-790052; Drug: Peginterferon alfa-2b; Drug: Ribavirin
Arm E (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)	Experimental	Non-Responder Receives: Drug: BMS-790052; Drug: Peginterferon alfa-2b; Drug: Ribavirin

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Extended Rapid Virologic Response (eRVR)
eRVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at both Weeks 4 and 12. HCV RNA levels were measured by Tobas TaqMan HCV Auto from the central laboratory.
Measured: At Weeks 4 and 12 on treatment

Secondary outcomes (4)

Percentage of Participants With Rapid Virologic Response (RVR)
RVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at Week 4. HCV RNA levels were measured by CobasTaqMan HCV Auto from the central laboratory .
Measured: At Week 4 on treatment
Percentage of Participants With Complete Early Virologic Response (cEVR)
cEVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at Week 12 on treatment. HCV RNA levels were measured by Cobas TaqMan HCV Auto from the central laboratory
Measured: At Week 12 on treatment
Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24
SVR at follow-up Week 4 (SVR4), follow-up Week 12 (SVR12), and follow-up Week 24 (SVR24) is defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at each of these timepoints. HCV RNA levels were measured by Cobas TaqMan HCV Auto from the central laboratory .
Measured: Follow-up Weeks 4, 12, and 24
Percentage of Participants With Virologic Failure
Virologic failure is defined by the following 6 categories: 1.Virologic breakthrough, defined as confirmed >1 log10 increase in hepatitis C virus (HCV) RNA over nadir or confirmed HCV RNA ≥limit of quantitation (LOQ) after confirmed undetectable HCV RNA while on treatment. 2. <1 log10 decrease in HCV RNA from baseline at Week 4 of treatment. 3. Failure to achieve early virologic response, defined as <2 log10 decrease in HCV RNA from baseline at Week 12 of treatment. 4. Detectable HCV RNA at Week 12, and HCV RNA ≥LOQ at Week 24 of treatment. 5. Detectable HCV RNA at end of treatment (including early discontinuation). 6 Relapse, defined as detectable HCV RNA during follow-up after undetectable HCV RNA levels at end of treatment.
Measured: From on-treatment Week 1 to 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.

Dec 2009Sep 2010

First posted20 Nov 2009 (estimated)
Study startDec 2009
Primary completionSep 2010
Study completionSep 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hepatitis C 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01016912
Sponsor's protocol ID: AI444-021
Status last verified: Sep 2015
First submitted: 19 Nov 2009
Last updated: 12 Oct 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Murakami E, Imamura M, Hayes CN, Abe H, Hiraga N, Honda Y, Ono A, Kosaka K, Kawaoka T, Tsuge M, Aikata H, Takahashi S, Miki D, Ochi H, Matsui H, Kanai A, Inaba T, McPhee F, Chayama K. Ultradeep sequencing study of chronic hepatitis C virus genotype 1 infection in patients treated with daclatasvir, peginterferon, and ribavirin. Antimicrob Agents Chemother. 2014;58(4):2105-12. doi: 10.1128/AAC.02068-13. Epub 2014 Jan 27.
PubMed 24468783

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hepatitis C Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2a Study of BMS-790052 in Combination With Peginterferon Alfa-2b (PegIntron®) and Ribavirin (Rebetol®) in Japanese Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
ClinicalTrials.gov ID: NCT01016912
Acronym / sponsor ID: AI444-021
Conditions: Hepatitis C Infection
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: Dec 2009
Primary completion: Sep 2010 (actual)
Study completion: Sep 2010 (actual)
First posted: 20 Nov 2009 (estimated)
Results: Posted 12 Oct 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Arm A (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)	Experimental	Drug: BMS-790052, Drug: Peginterferon alfa-2b, Drug: RibavirinTreatment Naive
Arm B (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)	Experimental	Drug: BMS-790052, Drug: Peginterferon alfa-2b, Drug: RibavirinTreatment Naive
Arm C (Placebo, plus Peginterferon alfa-2b, Ribavirin)	Placebo comparator	Drug: Placebo, Drug: Peginterferon alfa-2b, Drug: RibavirinTreatment Naive
Arm D (BMS-790052, plus peginterferon alfa-2b, Ribavirin)	Experimental	Drug: BMS-790052, Drug: Peginterferon alfa-2b, Drug: RibavirinNon-Responder
Arm E (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)	Experimental	Drug: BMS-790052, Drug: Peginterferon alfa-2b, Drug: RibavirinNon-Responder

Who may qualify

Ages: 20 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients chronically infected with hepatitis C virus (HCV) genotype 1
HCV RNA viral load ≥10*5* IU/mL at screening
Naïve or nonresponsive to the current standard of care

Key exclusion criteria (3 listed)

Cirrhosis
Hepatocellular carcinoma
Coinfection with hepatitis B virus, HIV-1 or HIV-2

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-790052Tablets, Oral, 10 mg, daily, 24-48 weeks	Drug	Arm A (BMS-790052, plus Peginterferon alfa-2b, Ribavirin), Arm D (BMS-790052, plus peginterferon alfa-2b, Ribavirin)
BMS-790052Tablets, Oral, 60 mg, daily, 24-48 weeks	Drug	Arm B (BMS-790052, plus Peginterferon alfa-2b, Ribavirin), Arm E (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)
PlaceboTablets, Oral, 0 mg, daily, 48 weeks	Drug	Arm C (Placebo, plus Peginterferon alfa-2b, Ribavirin)
Peginterferon alfa-2bAlso: PegIntron®Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks	Drug	Arm A (BMS-790052, plus Peginterferon alfa-2b, Ribavirin), Arm B (BMS-790052, plus Peginterferon alfa-2b, Ribavirin), Arm C (Placebo, plus Peginterferon alfa-2b, Ribavirin), Arm D (BMS-790052, plus peginterferon alfa-2b, Ribavirin), Arm E (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)
RibavirinAlso: Rebetol®Capsules, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks	Drug	Arm A (BMS-790052, plus Peginterferon alfa-2b, Ribavirin), Arm B (BMS-790052, plus Peginterferon alfa-2b, Ribavirin), Arm C (Placebo, plus Peginterferon alfa-2b, Ribavirin), Arm D (BMS-790052, plus peginterferon alfa-2b, Ribavirin), Arm E (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)

Primary outcome

Percentage of Participants With Extended Rapid Virologic Response (eRVR)
Time frame: At Weeks 4 and 12 on treatment
eRVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at both Weeks 4 and 12. HCV RNA levels were measured by Tobas TaqMan HCV Auto from the central laboratory.

4 secondary outcomes

Percentage of Participants With Rapid Virologic Response (RVR)
Time frame: At Week 4 on treatment
Percentage of Participants With Complete Early Virologic Response (cEVR)
Time frame: At Week 12 on treatment
Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24
Time frame: Follow-up Weeks 4, 12, and 24
Percentage of Participants With Virologic Failure
Time frame: From on-treatment Week 1 to Follow-up Week 24

Results and safety

Results posted to the registry on 12 Oct 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo + pegIFNα + Ribavirin (Treatment-naive)	8	8
Daclatasvir 10- mg + pegIFNα + Ribavirin (Treatment-naive)	9	6
Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive)	10	9
Daclatasvir 10- mg + pegIFNα+ Ribavirin (Nonresponders)	9	5
Daclatasvir 60- mg + pegIFNα + Ribavirin (Nonresponders)	9	5

Primary outcome: Percentage of Participants With Extended Rapid Virologic Response (eRVR)

Time frame: At Weeks 4 and 12 on treatment. Number (80% Confidence Interval). Unit: percentage of participants

Measure	Placebo + pegIFNα + Ribavirin (Treatment-naive) n = 8	Daclatasvir 10- mg + pegIFNα + Ribavirin (Treatment-naive) n = 9	Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment Naive) n = 10	Daclatasvir 10- mg + pegINFα + Ribavirin (Nonresponders) n = 9	Daclatasvir 60- mg + pegIFNα + Ribavirin (Nonresponders) n = 9
Value	0 (0.0 to 25.0)	66.7 (40.1 to 87.1)	80.0 (55.0 to 94.5)	55.6 (30.1 to 79.0)	22.2 (6.1 to 49.0)

Population analysed: All participants who received at least 1 dose of study therapy.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline up to 30 days after last dose of study drug. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo+pegIFNα +Ribavirin (Treatment Naive)	0 of 8 (0%)	8 of 8 (100%)	Not reported
Daclatasvir 10- mg+pegIFNα+Ribavirin (Treatment Naive)	0 of 9 (0%)	9 of 9 (100%)	Not reported
Daclatasvir 60- mg+pegIFNα+Ribavirin (Treatment Naive)	0 of 10 (0%)	10 of 10 (100%)	Not reported
Daclatasvir 10- mg+pegIFNα+Ribavirin (Non--Responders)	1 of 9 (11.1%)	9 of 9 (100%)	Not reported
Daclatasvir 60- mg+pegIFNα+Ribavirin (Non--Responders)	0 of 9 (0%)	9 of 9 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24468783Murakami E, Imamura M, Hayes CN, Abe H, Hiraga N, Honda Y, Ono A, Kosaka K, Kawaoka T, Tsuge M, Aikata H, Takahashi S, Miki D, Ochi H, Matsui H, Kanai A, Inaba T, McPhee F, Chayama K. Ultradeep sequencing study of chronic hepatitis C virus genotype 1 infection in patients treated with daclatasvir, peginterferon, and ribavirin. Antimicrob Agents Chemother. 2014;58(4):2105-12. doi: 10.1128/AAC.02068-13. Epub 2014 Jan 27.

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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

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BMS-790052, Peginterferon alfa-2b and Ribavirin in people with Hepatitis C Infection, run by Bristol-Myers Squibb at 6 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 3 inclusion and 3 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 12 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 6 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Extended Rapid Virologic Response (eRVR) (time frame: At Weeks 4 and 12 on treatment). 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 NCT01016912, which also lists 1 linked publication.

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 12 Oct 2015.