Hepatitis C InfectionPhase 2NCT00874770

Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha and Ribavirin)

A Phase 2 study testing Daclatasvir, Peginterferon alpha-2a and ribavirin in people with Hepatitis C Infection, run by Bristol-Myers Squibb at 14 sites in 2 countries.

Completed

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

Official record

Search all trials

Trial summary

The purpose of this study is to identify 1 or more doses of daclatasvir, which when used in combination with pegylated interferon alpha and ribavirin, are safe and demonstrate sufficient anti-hepatitis C virus activity. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Hepatitis C Infection
What is being tested?: Daclatasvir, Peginterferon alpha-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: 74 participants
Where: 14 sitesin 2 countries
Study dates: Jun 2009to Jan 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 18 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 of ≥10*5* IU/mL (100,000 IU/mL) at screening
Treatment naive

Who cannot join

Women of child-bearing potential
Cirrhosis
Coinfection with HIV or hepatitis B virus

Trial locations and contacts

14 sites in 2 countries.

Country

City, postcode or hospital

14 sites in 2 countries

United States11 sites

North Texas Research Institute
Arlington, Texas, 76012
University Of Colorado Denver & Hospital
Aurora, Colorado, 80045
Mercy Medical Center
Baltimore, Maryland, 21202
Metropolitan Research
Fairfax, Virginia, 22031
Alabama Liver & Digestive Specialists (Alds)
Montgomery, Alabama, 36116
Yale University School Of Medicine
New Haven, Connecticut, 06520
Llc Dba The Research Institute
Springfield, Massachusetts, 01107
Carolinas Center For Liver Disease
Statesville, North Carolina, 28677
Veterans Affairs Medical Center
The Bronx, New York, 10468
Options Health Research, Llc
Tulsa, Oklahoma, 74104
Healthcare Research Consultants
Tulsa, Oklahoma, 74135

Other trials in United States

France3 sites

Local Institution
Créteil, 94010
Local Institution
Paris, 75679
Local Institution
Vandœuvre-lès-Nancy, 54511

Other trials in France

About this study

Official title: A Phase 2a Study of BMS-790052 in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype 1

Conditions: Hepatitis C Infection
Being tested: Daclatasvir, Placebo, Peginterferon alpha-2a, ribavirin
Keywords: Antivirals
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, 3 mg, Daily, 48 weeks
DaclatasvirDrug
Tablets, oral, 10 mg, Daily, 48 weeks
DaclatasvirDrug
Tablets, oral, 60 mg, Daily, 48 weeks
PlaceboDrug
Tablet, oral, 0 mg, Daily 48 weeks
Peginterferon alpha-2aDrug
Also called Pegasys
Syringe, subcutaneous, 180 µg, Weekly, 48 weeks
ribavirinDrug
Also called Copegus
Tablet, oral, 1000 or 1200 mg, based on weight, Daily, 48 weeks

Study groups in NCT00874770
Study group	Role	What they receive
Daclatasvir, plus Peginterferon alpha-2a, ribavirin (A)	Experimental	Active Comparator Receives: Drug: Daclatasvir; Drug: Peginterferon alpha-2a; Drug: ribavirin
Daclatasvir, Peginterferon alpha-2a, ribavirin (B)	Experimental	Active Comparator Receives: Drug: Daclatasvir; Drug: Peginterferon alpha-2a; Drug: ribavirin
Daclatasvir, Peginterferon alpha-2a, ribavirin (C)	Experimental	Active Comparator Receives: Drug: Daclatasvir; Drug: Peginterferon alpha-2a; Drug: ribavirin
Placebo, Peginterferon alpha-2a, ribavirin (D)	Active comparator	Not described Receives: Drug: Placebo; Drug: Peginterferon alpha-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) at Weeks 4 and 12
eRVR was defined as undetectable hepatitis C virus RNA less than the lower limit of detection (10 IU/mL) at Weeks 4 and 12.
Measured: A Weeks 4 and 12

Secondary outcomes (3)

Percentage of Participants With Rapid Virologic Response (RVR) at Week 4
RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA less than the lower limit of detection (10 IU/mL) at Week 4.
Measured: At Week 4
Percentage of Participants With Early Virologic Response (EVR) at Week 12
EVR was defined as a ≥2 log10 decrease in hepatitis C virus (HCV) RNA from baseline at Week 12 , or HCV RNA <10 IU/mL for participants with baseline HCV RNA <1000 IU/mL.
Measured: At Week 12
Percentage of Participants With a Complete Early Virologic Response (cEVR) at Week 12
cEVR was defined as hepatitis C virus RNA <10 IU/mL at Week 12
Measured: At Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2009Jan 2011

First posted3 Apr 2009 (estimated)
Study startJun 2009
Primary completionNov 2009
Study completionJan 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.
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: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00874770
Sponsor's protocol ID: AI444-014
Other IDs: EUDRACT# 2009-010149-29
Status last verified: Sep 2015
First submitted: 2 Apr 2009
Last updated: 23 Oct 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Pol S, Ghalib RH, Rustgi VK, Martorell C, Everson GT, Tatum HA, Hezode C, Lim JK, Bronowicki JP, Abrams GA, Brau N, Morris DW, Thuluvath PJ, Reindollar RW, Yin PD, Diva U, Hindes R, McPhee F, Hernandez D, Wind-Rotolo M, Hughes EA, Schnittman S. Daclatasvir for previously untreated chronic hepatitis C genotype-1 infection: a randomised, parallel-group, double-blind, placebo-controlled, dose-finding, phase 2a trial. Lancet Infect Dis. 2012 Sep;12(9):671-7. doi: 10.1016/S1473-3099(12)70138-X. Epub 2012 Jun 18.
PubMed 22714001

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

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
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
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic

All Hepatitis C Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 23 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-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype 1
ClinicalTrials.gov ID: NCT00874770
Acronym / sponsor ID: AI444-014
Conditions: Hepatitis C Infection
Keywords: Antivirals
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: Jun 2009
Primary completion: Nov 2009 (actual)
Study completion: Jan 2011 (actual)
First posted: 3 Apr 2009 (estimated)
Results: Posted 23 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: 4

Arm	Type	Receives
Daclatasvir, plus Peginterferon alpha-2a, ribavirin (A)	Experimental	Drug: Daclatasvir, Drug: Peginterferon alpha-2a, Drug: ribavirinActive Comparator
Daclatasvir, Peginterferon alpha-2a, ribavirin (B)	Experimental	Drug: Daclatasvir, Drug: Peginterferon alpha-2a, Drug: ribavirinActive Comparator
Daclatasvir, Peginterferon alpha-2a, ribavirin (C)	Experimental	Drug: Daclatasvir, Drug: Peginterferon alpha-2a, Drug: ribavirinActive Comparator
Placebo, Peginterferon alpha-2a, ribavirin (D)	Active comparator	Drug: Placebo, Drug: Peginterferon alpha-2a, Drug: ribavirin

Who may qualify

Ages: 18 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 of ≥10*5* IU/mL (100,000 IU/mL) at screening
Treatment naive

Key exclusion criteria (3 listed)

Women of child-bearing potential
Cirrhosis
Coinfection with HIV or hepatitis B virus

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, 3 mg, Daily, 48 weeks	Drug	Daclatasvir, plus Peginterferon alpha-2a, ribavirin (A)
DaclatasvirTablets, oral, 10 mg, Daily, 48 weeks	Drug	Daclatasvir, Peginterferon alpha-2a, ribavirin (B)
DaclatasvirTablets, oral, 60 mg, Daily, 48 weeks	Drug	Daclatasvir, Peginterferon alpha-2a, ribavirin (C)
PlaceboTablet, oral, 0 mg, Daily 48 weeks	Drug	Placebo, Peginterferon alpha-2a, ribavirin (D)
Peginterferon alpha-2aAlso: PegasysSyringe, subcutaneous, 180 µg, Weekly, 48 weeks	Drug	Daclatasvir, Peginterferon alpha-2a, ribavirin (B), Daclatasvir, Peginterferon alpha-2a, ribavirin (C), Daclatasvir, plus Peginterferon alpha-2a, ribavirin (A), Placebo, Peginterferon alpha-2a, ribavirin (D)
ribavirinAlso: CopegusTablet, oral, 1000 or 1200 mg, based on weight, Daily, 48 weeks	Drug	Daclatasvir, Peginterferon alpha-2a, ribavirin (B), Daclatasvir, Peginterferon alpha-2a, ribavirin (C), Daclatasvir, plus Peginterferon alpha-2a, ribavirin (A), Placebo, Peginterferon alpha-2a, ribavirin (D)

Primary outcome

Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12
Time frame: A Weeks 4 and 12
eRVR was defined as undetectable hepatitis C virus RNA less than the lower limit of detection (10 IU/mL) at Weeks 4 and 12.

3 secondary outcomes

Percentage of Participants With Rapid Virologic Response (RVR) at Week 4
Time frame: At Week 4
Percentage of Participants With Early Virologic Response (EVR) at Week 12
Time frame: At Week 12
Percentage of Participants With a Complete Early Virologic Response (cEVR) at Week 12
Time frame: At Week 12

Results and safety

Results posted to the registry on 23 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
Daclatasvir 3 mg + pegIFNα-2a + Ribavirin	12	7
Daclatasvir 10 mg + pegIFNα-2a + Ribavirin	12	11
Daclatasvir 60 mg + pegIFNα-2a + Ribavirin	12	8
Placebo+pegIFNα-2a+Ribavirin	12	7

Primary outcome: Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12

Time frame: A Weeks 4 and 12. Number. Unit: percentage of participants

Measure	Daclatasvir 3 mg + pegIFNα-2a + Ribavirin n = 12	Daclatasvir 10 mg + pegIFNα-2a + Ribavirin n = 12	Daclatasvir 60 mg + pegIFNα-2a + Ribavirin n = 12	Placebo + pegIFNα-2a + Ribavirin n = 12
Value	41.7	83.3	75	8.3

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

3 secondary outcomes are reported in the full results.

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
Daclatasvir 3 mg + pegIFNα-2a + Ribavirin	1 of 12 (8.3%)	12 of 12 (100%)	Not reported
Daclatasvir 10 mg + pegIFNα-2a + Ribavirin	1 of 12 (8.3%)	12 of 12 (100%)	Not reported
Daclatasvir 60 mg + pegIFNα-2a + Ribavirin	1 of 12 (8.3%)	12 of 12 (100%)	Not reported
Placebo + pegIFNα-2a + Ribavirin	0 of 12 (0%)	12 of 12 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22714001Pol S, Ghalib RH, Rustgi VK, Martorell C, Everson GT, Tatum HA, Hezode C, Lim JK, Bronowicki JP, Abrams GA, Brau N, Morris DW, Thuluvath PJ, Reindollar RW, Yin PD, Diva U, Hindes R, McPhee F, Hernandez D, Wind-Rotolo M, Hughes EA, Schnittman S. Daclatasvir for previously untreated chronic hepatitis C genotype-1 infection: a randomised, parallel-group, double-blind, placebo-controlled, dose-finding, phase 2a trial. Lancet Infect Dis. 2012 Sep;12(9):671-7. doi: 10.1016/S1473-3099(12)70138-X. Epub 2012 Jun 18.

Related trials for Hepatitis C Infection

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
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
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic

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

14 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Daclatasvir, Peginterferon alpha-2a and ribavirin in people with Hepatitis C Infection, run by Bristol-Myers Squibb at 14 sites in 2 countries.

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 23 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 14 sites in United States, France. 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 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 23 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) at Weeks 4 and 12 (time frame: A Weeks 4 and 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 NCT00874770, 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 23 Oct 2015.