Hepatitis C InfectionPhase 2NCT01017575

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

A Phase 2 study testing Daclatasvir, Peginterferon alfa-2a 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 when combined with peginterferon-alfa (PegIFNα) and ribavirin (RBV) for the treatment of chronically infected HCV genotype 1 treatment-naïve and non-responder to standard of care subjects is safe, well tolerated, and efficacious 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?: Daclatasvir, Peginterferon alfa-2a 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: 55 participants
Where: 6 sitesJapan
Study dates: Dec 2009to Oct 2011
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

Subjects chronically infected with hepatitis C virus (HCV) genotype 1
HCV RNA viral load ≥ 10*5* IU/mL (100,000 IU/mL) at screening
The current standard of care naïve or non-responder

Who cannot join

Cirrhosis
HCC
Co-infection with hepatitis B virus (HBV), 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
Chiba, Chiba
Local Institution
Kurume-Shi, Fukuoka, 8300011
Local Institution
Musashino-Shi, Tokyo, 180-0023
Local Institution
Okayama, Okayama-ken, 7008558
Local Institution
Osaka, Osaka, 5438555
Local Institution
Osaka, Osaka, 545-8586

Other trials in Japan

About this study

Official title: A Phase 2a Study of Daclatasvir in Combination With Peginterferon Alfa-2a(Pegasys®) and Ribavirin (Copegus®) in Japanese Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

Conditions: Hepatitis C Infection
Being tested: Daclatasvir, Placebo, Peginterferon alfa-2a, 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.

DaclatasvirDrug
Tablets, Oral, 10 mg, daily, 24-48 weeks
DaclatasvirDrug
Tablets, Oral, 60 mg, daily, 24-48 weeks
PlaceboDrug
Tablets, Oral, 0 mg, daily, 48 weeks
Peginterferon alfa-2aDrug
Also called Pegasys®
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
RibavirinDrug
Also called Copegus®
Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks

Study groups in NCT01017575
Study group	Role	What they receive
Arm A (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)	Experimental	Treatment Naive Receives: Drug: Daclatasvir; Drug: Peginterferon alfa-2a; Drug: Ribavirin
Arm B (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)	Experimental	Treatment Naive Receives: Drug: Daclatasvir; Drug: Peginterferon alfa-2a; Drug: Ribavirin
Arm C (Placebo, plus Peginterferon alfa-2a, Ribavirin)	Placebo comparator	Treatment Naive Receives: Drug: Placebo; Drug: Peginterferon alfa-2a; Drug: Ribavirin
Arm D (Daclatasvir, plus peginterferon alfa-2a, Ribavirin)	Experimental	Non-Responder Receives: Drug: Daclatasvir; Drug: Peginterferon alfa-2a; Drug: Ribavirin
Arm E (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)	Experimental	Non-Responder Receives: Drug: Daclatasvir; Drug: Peginterferon alfa-2a; 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 at both Weeks 4 and 12.
Measured: From Week 4 up to Week 12

Secondary outcomes (3)

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 at Week 4.
Measured: Week 4
Percentage of Participants With a Complete Early Virologic Response (cEVR)
cEVR was defined as hepatitis C virus RNA <15 IU/mL at Week 12.
Measured: Week 12
Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24
SVR at Follow-up Week 12 (SVR12) and SVR at Follow-up week 24 (SVR24) was defined as hepatitis C virus (HCV) RNA <15 IU/mL at follow-up Weeks 12 and 24.
Measured: Follow up Week 12, 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 2009Oct 2011

First posted20 Nov 2009 (estimated)
Study startDec 2009
Primary completionOct 2011
Study completionOct 2011

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.
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: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01017575
Sponsor's protocol ID: AI444-022
Status last verified: Aug 2015
First submitted: 19 Nov 2009
Last updated: 11 Sep 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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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Evaluation of Patients With Liver Disease
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Elimination of Hepatitis C Virus Among Users of Substances
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Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
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Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
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Diabetes Mellitus, Hepatitis C, Chronic

All Hepatitis C Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2a Study of Daclatasvir in Combination With Peginterferon Alfa-2a(Pegasys®) and Ribavirin (Copegus®) in Japanese Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
ClinicalTrials.gov ID: NCT01017575
Acronym / sponsor ID: AI444-022
Conditions: Hepatitis C Infection
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: Dec 2009
Primary completion: Oct 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 20 Nov 2009 (estimated)
Results: Posted 11 Sep 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 (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)	Experimental	Drug: Daclatasvir, Drug: Peginterferon alfa-2a, Drug: RibavirinTreatment Naive
Arm B (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)	Experimental	Drug: Daclatasvir, Drug: Peginterferon alfa-2a, Drug: RibavirinTreatment Naive
Arm C (Placebo, plus Peginterferon alfa-2a, Ribavirin)	Placebo comparator	Drug: Placebo, Drug: Peginterferon alfa-2a, Drug: RibavirinTreatment Naive
Arm D (Daclatasvir, plus peginterferon alfa-2a, Ribavirin)	Experimental	Drug: Daclatasvir, Drug: Peginterferon alfa-2a, Drug: RibavirinNon-Responder
Arm E (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)	Experimental	Drug: Daclatasvir, Drug: Peginterferon alfa-2a, 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)

Subjects chronically infected with hepatitis C virus (HCV) genotype 1
HCV RNA viral load ≥ 10*5* IU/mL (100,000 IU/mL) at screening
The current standard of care naïve or non-responder

Key exclusion criteria (3 listed)

Cirrhosis
HCC
Co-infection with hepatitis B virus (HBV), 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
DaclatasvirTablets, Oral, 10 mg, daily, 24-48 weeks	Drug	Arm A (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin), Arm D (Daclatasvir, plus peginterferon alfa-2a, Ribavirin)
DaclatasvirTablets, Oral, 60 mg, daily, 24-48 weeks	Drug	Arm B (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin), Arm E (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)
PlaceboTablets, Oral, 0 mg, daily, 48 weeks	Drug	Arm C (Placebo, plus Peginterferon alfa-2a, Ribavirin)
Peginterferon alfa-2aAlso: Pegasys®Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks	Drug	Arm A (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin), Arm B (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin), Arm C (Placebo, plus Peginterferon alfa-2a, Ribavirin), Arm D (Daclatasvir, plus peginterferon alfa-2a, Ribavirin), Arm E (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)
RibavirinAlso: Copegus®Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks	Drug	Arm A (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin), Arm B (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin), Arm C (Placebo, plus Peginterferon alfa-2a, Ribavirin), Arm D (Daclatasvir, plus peginterferon alfa-2a, Ribavirin), Arm E (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)

Primary outcome

Percentage of Participants With Extended Rapid Virologic Response (eRVR)
Time frame: From Week 4 up to Week 12
eRVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA <15 IU/mL, the lower limit of detection at both Weeks 4 and 12.

3 secondary outcomes

Percentage of Participants With Rapid Virologic Response (RVR)
Time frame: Week 4
Percentage of Participants With a Complete Early Virologic Response (cEVR)
Time frame: Week 12
Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24
Time frame: Follow up Week 12, Follow up Week 24

Results and safety

Results posted to the registry on 11 Sep 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-2a+Ribavirin (Treatment Naive)	8	7
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)	9	7
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)	8	8
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)	8	7
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)	9	6

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

Time frame: From Week 4 up to Week 12. Number. Unit: percentage of participants

Measure	Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) n = 8	Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) n = 9	Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) n = 8	Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) n = 8	Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) n = 9
Value	12.5	66.7	62.5	62.5	77.8

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

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)	0 of 8 (0%)	8 of 8 (100%)	Not reported
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)	2 of 9 (22.2%)	9 of 9 (100%)	Not reported
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)	0 of 8 (0%)	8 of 8 (100%)	Not reported
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)	0 of 8 (0%)	8 of 8 (100%)	Not reported
Daclatasvir 60-mg+pegIFNα-2a+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 11 Sep 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hepatitis C Infection

RecruitingObservational study
Evaluation of Patients With Liver Disease
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Not yet recruitingObservational study
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Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
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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 Daclatasvir, Peginterferon alfa-2a 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 11 Sep 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 11 Sep 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: From Week 4 up to Week 12). 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 NCT01017575.

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 11 Sep 2015.