Hepatitis C VirusPhase 2NCT01629732

Phase 2b Study of BMS-986094 and Daclatasvir, With or Without Ribavirin for the Treatment of Patients With Chronic Hepatitis C

A Phase 2 study testing Daclatasvir, BMS-986094 and Ribavirin in people with Hepatitis C Virus, run by Bristol-Myers Squibb at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

The purpose of this study is to evaluate the effectiveness of BMS-986094 and Daclatasvir (DCV) when given in combination with or without Ribavirin Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis C Virus
What is being tested?: Daclatasvir, BMS-986094 and Ribavirin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: 1 siteUnited States
Study dates: Mar 2013to Jun 2014
Phase: Phase 2
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males and females, ≥ 18 years of age
Subjects chronically infected with Hepatitis C virus (HCV) genotype 1,2,3 or 4
HCV RNA viral load ≥ 10,000 IU/mL
Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population)
Body Mass Index (BMI) of 18 to 35 kg/m2
Seronegative for Hepatitis C virus (HIV) and Hepatitis B

Who cannot join

Evidence of decompensated liver disease
Evidence of medical condition contributing to chronic liver disease other than HCV

Trial locations and contacts

1 site in 1 country.

United States1 site

Local Institution
Orlando, Florida, 32804

Other trials in United States

About this study

Official title: Phase 2b Evaluation of PegIFNα Free Combinations of BMS-986094 (INX-08189) and Daclatasvir, With or Without Ribavirin, in Treatment Naive and Treatment Experienced Patients With Chronic Hepatitis C

The purpose of this study is to evaluate the effectiveness of BMS-986094 and Daclatasvir (DCV) when given in combination with or without Ribavirin

Conditions: Hepatitis C Virus
Being tested: Daclatasvir, BMS-986094, Ribavirin, Placebo for BMS-986094
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
Also called BMS-790052 (DCV)
Film coated tablet, Oral, 60 mg, Once daily, 12 or 24 weeks
DaclatasvirDrug
Also called BMS-790052 (DCV)
Film coated tablet, Oral, 60 mg, Once daily, 24 weeks
BMS-986094Drug
Capsule, Oral, 100 mg, Once daily, 12 or 24 weeks
BMS-986094Drug
Capsule, Oral, 200 mg, Once daily, 12 or 24 weeks
BMS-986094Drug
Capsule, Oral, 200 mg, Once daily, 24 Weeks
RibavirinDrug
Also called Copegus®
Film coated tablet, Oral, 1000 mg or 1200 mg based on weight, Twice daily, 12 or 24 weeks
Placebo for BMS-986094Drug
Capsule, Oral, 0 mg, Once daily, 12 or 24 weeks

Study groups in NCT01629732
Study group	Role	What they receive
Arm 1: Daclasasvir + BMS-986094 (100 mg) + Placebo	Experimental	Subjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy) Re-Randomized Arm 1 to Arm 1a and 1b (additional 12 weeks treatment) Receives: Drug: Daclatasvir; Drug: BMS-986094; Drug: Placebo for BMS-986094
Arm 2: Daclasasvir + BMS-986094 (200 mg)	Experimental	Subjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy) Re-Randomized Arm 2 to Arm 2a and 2b (additional 12 weeks treatment) Receives: Drug: Daclatasvir; Drug: BMS-986094
Arm 3: Daclasasvir + BMS-986094 (100 mg) + Placebo + Ribavirin	Experimental	Subjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy) Re-Randomized Arm 3 to Arm 3a and 3b (additional 12 weeks treatment) Receives: Drug: Daclatasvir; Drug: BMS-986094; Drug: Ribavirin; Drug: Placebo for BMS-986094
Arm 4: Daclasasvir + BMS-986094 (200 mg) + Ribavirin	Experimental	Subjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy) Re-Randomized Arm 4 to Arm 4a and 4b (additional 12 weeks treatment) Receives: Drug: Daclatasvir; Drug: BMS-986094; Drug: Ribavirin
Arm 5: Daclasasvir + BMS-986094 (200 mg)	Experimental	Genotype 1 PI-failure subjects Receives: Drug: Daclatasvir; Drug: BMS-986094
Arm 6: Daclasasvir + BMS-986094 (200 mg)	Experimental	Genotype 4 naive subjects Receives: Drug: Daclatasvir; Drug: BMS-986094
Arm 7: Daclasasvir + BMS-986094 (200 mg)	Experimental	Genotype 2/3 NR/relapse Subjects Receives: Drug: Daclatasvir; Drug: BMS-986094

What is being measured

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

Proportion of subjects with SVR4 defined as HCV RNA < LOQ (25 IU/mL; detectable or undetectable) at 4 weeks post treatment to be evaluated in GT1 (naive and NR) subjects randomized to the 12-week treatment arm (arms 1a, 2a, 3a, 4a)
- SVR = Sustained virologic response
- HCV = Hepatitis C virus
- RNA = Ribonucleic acid
- LOQ = Limit of quantitation
Measured: Follow up Week 4

Secondary outcomes (6)

Proportion of treated subjects with SVR4 in genotype (GT) 1 naive and non-responder (NR) subjects randomized to the 24-week treatment arms (arms 1b, 2b, 3b, 4b)
Measured: Follow up Week 4 (SVR4)
Proportion of treated subjects with SVR4 in genotype 1 protease inhibitor (PI)failures, genotype 4 naive, and genotype 2/3 NR/relapse subjects (arms 5, 6, 7)
Measured: Follow up Week 4 (SVR4)
Proportion of treated subjects in each study population (GT1 naive, GT1 NR, or GT1 PI-failure, GT4 naive, GT2/3 NR/relapse), for each regimen and duration, who achieve HCV RNA < LOQ at post-treatment
Measured: Post-treatment Week 2 (SVR2), Week 8 (SVR8), Week 12 (SVR12), Week 24 (SVR24), and Week 36 (SVR36, for the 12 week arms)
Proportion of treated subjects in each study population, by regimen, who achieve HCV RNA < LOQ (detectable/undetectable)
Measured: Weeks 1, 2, 4, 6, 8, 12 and End of Treatment (Week 12 or 24)
Proportion of subjects in each study population, be regimen, who achieve HCV RNA undetectable
Measured: Weeks 1, 2, 4, 6, 8, 12 and End of Treatment (Week 12 or 24)
Safety and tolerability of BMS-986094 and DCV ± RBV as measured by the frequency of deaths, serious adverse events (SAEs), discontinuations due to Adverse Events (AEs), and severity Grade 3/4 laboratory abnormalities
Measured: Up to post treatment Week 36

Timeline

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

Mar 2013Jun 2014

First posted28 Jun 2012 (estimated)
Study startMar 2013
Primary completionFeb 2014 (estimated)
Study completionJun 2014 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hepatitis C VirusStudies 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: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01629732
Sponsor's protocol ID: AI472-007
Other IDs: 2012-002519-24
Status last verified: May 2014
First submitted: 26 Jun 2012
Last updated: 9 May 2014
Results posted: No
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?

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Study at a glance

From the registry record, last updated by the sponsor on 9 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2b Evaluation of PegIFNα Free Combinations of BMS-986094 (INX-08189) and Daclatasvir, With or Without Ribavirin, in Treatment Naive and Treatment Experienced Patients With Chronic Hepatitis C
ClinicalTrials.gov ID: NCT01629732
Acronym / sponsor ID: AI472-007
Conditions: Hepatitis C Virus
Phase: Phase 2
Study type: Interventional
Recruitment status: Withdrawn
Enrolment: 0 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: Mar 2013
Primary completion: Feb 2014 (estimated)
Study completion: Jun 2014 (estimated)
First posted: 28 Jun 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 evaluate the effectiveness of BMS-986094 and Daclatasvir (DCV) when given in combination with or without Ribavirin

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 7

Arm	Type	Receives
Arm 1: Daclasasvir + BMS-986094 (100 mg) + Placebo	Experimental	Drug: Daclatasvir, Drug: BMS-986094, Drug: Placebo for BMS-986094Subjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy) Re-Randomized Arm 1 to Arm 1a and 1b (additional 12 weeks treatment)
Arm 2: Daclasasvir + BMS-986094 (200 mg)	Experimental	Drug: Daclatasvir, Drug: BMS-986094Subjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy) Re-Randomized Arm 2 to Arm 2a and 2b (additional 12 weeks treatment)
Arm 3: Daclasasvir + BMS-986094 (100 mg) + Placebo + Ribavirin	Experimental	Drug: Daclatasvir, Drug: BMS-986094, Drug: Ribavirin, Drug: Placebo for BMS-986094Subjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy) Re-Randomized Arm 3 to Arm 3a and 3b (additional 12 weeks treatment)
Arm 4: Daclasasvir + BMS-986094 (200 mg) + Ribavirin	Experimental	Drug: Daclatasvir, Drug: BMS-986094, Drug: RibavirinSubjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy) Re-Randomized Arm 4 to Arm 4a and 4b (additional 12 weeks treatment)
Arm 5: Daclasasvir + BMS-986094 (200 mg)	Experimental	Drug: Daclatasvir, Drug: BMS-986094Genotype 1 PI-failure subjects
Arm 6: Daclasasvir + BMS-986094 (200 mg)	Experimental	Drug: Daclatasvir, Drug: BMS-986094Genotype 4 naive subjects
Arm 7: Daclasasvir + BMS-986094 (200 mg)	Experimental	Drug: Daclatasvir, Drug: BMS-986094Genotype 2/3 NR/relapse Subjects

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Males and females, ≥ 18 years of age
Subjects chronically infected with Hepatitis C virus (HCV) genotype 1,2,3 or 4
HCV RNA viral load ≥ 10,000 IU/mL
Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population)
Body Mass Index (BMI) of 18 to 35 kg/m2

Key exclusion criteria (2 listed)

Evidence of decompensated liver disease
Evidence of medical condition contributing to chronic liver disease other than HCV

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
DaclatasvirAlso: BMS-790052 (DCV)Film coated tablet, Oral, 60 mg, Once daily, 12 or 24 weeks	Drug	Arm 1: Daclasasvir + BMS-986094 (100 mg) + Placebo, Arm 2: Daclasasvir + BMS-986094 (200 mg), Arm 3: Daclasasvir + BMS-986094 (100 mg) + Placebo + Ribavirin, Arm 4: Daclasasvir + BMS-986094 (200 mg) + Ribavirin
DaclatasvirAlso: BMS-790052 (DCV)Film coated tablet, Oral, 60 mg, Once daily, 24 weeks	Drug	Arm 5: Daclasasvir + BMS-986094 (200 mg), Arm 6: Daclasasvir + BMS-986094 (200 mg), Arm 7: Daclasasvir + BMS-986094 (200 mg)
BMS-986094Capsule, Oral, 100 mg, Once daily, 12 or 24 weeks	Drug	Arm 1: Daclasasvir + BMS-986094 (100 mg) + Placebo, Arm 3: Daclasasvir + BMS-986094 (100 mg) + Placebo + Ribavirin
BMS-986094Capsule, Oral, 200 mg, Once daily, 12 or 24 weeks	Drug	Arm 2: Daclasasvir + BMS-986094 (200 mg), Arm 4: Daclasasvir + BMS-986094 (200 mg) + Ribavirin
BMS-986094Capsule, Oral, 200 mg, Once daily, 24 Weeks	Drug	Arm 5: Daclasasvir + BMS-986094 (200 mg), Arm 6: Daclasasvir + BMS-986094 (200 mg), Arm 7: Daclasasvir + BMS-986094 (200 mg)
RibavirinAlso: Copegus®Film coated tablet, Oral, 1000 mg or 1200 mg based on weight, Twice daily, 12 or 24 weeks	Drug	Arm 3: Daclasasvir + BMS-986094 (100 mg) + Placebo + Ribavirin, Arm 4: Daclasasvir + BMS-986094 (200 mg) + Ribavirin
Placebo for BMS-986094Capsule, Oral, 0 mg, Once daily, 12 or 24 weeks	Drug	Arm 1: Daclasasvir + BMS-986094 (100 mg) + Placebo, Arm 3: Daclasasvir + BMS-986094 (100 mg) + Placebo + Ribavirin

Primary outcome

Proportion of subjects with SVR4 defined as HCV RNA < LOQ (25 IU/mL; detectable or undetectable) at 4 weeks post treatment to be evaluated in GT1 (naive and NR) subjects randomized to the 12-week treatment arm (arms 1a, 2a, 3a, 4a)
Time frame: Follow up Week 4
* SVR = Sustained virologic response * HCV = Hepatitis C virus * RNA = Ribonucleic acid * LOQ = Limit of quantitation

6 secondary outcomes

Proportion of treated subjects with SVR4 in genotype (GT) 1 naive and non-responder (NR) subjects randomized to the 24-week treatment arms (arms 1b, 2b, 3b, 4b)
Time frame: Follow up Week 4 (SVR4)
Proportion of treated subjects with SVR4 in genotype 1 protease inhibitor (PI)failures, genotype 4 naive, and genotype 2/3 NR/relapse subjects (arms 5, 6, 7)
Time frame: Follow up Week 4 (SVR4)
Proportion of treated subjects in each study population (GT1 naive, GT1 NR, or GT1 PI-failure, GT4 naive, GT2/3 NR/relapse), for each regimen and duration, who achieve HCV RNA < LOQ at post-treatment
Time frame: Post-treatment Week 2 (SVR2), Week 8 (SVR8), Week 12 (SVR12), Week 24 (SVR24), and Week 36 (SVR36, for the 12 week arms)
Proportion of treated subjects in each study population, by regimen, who achieve HCV RNA < LOQ (detectable/undetectable)
Time frame: Weeks 1, 2, 4, 6, 8, 12 and End of Treatment (Week 12 or 24)
Proportion of subjects in each study population, be regimen, who achieve HCV RNA undetectable
Time frame: Weeks 1, 2, 4, 6, 8, 12 and End of Treatment (Week 12 or 24)
Safety and tolerability of BMS-986094 and DCV ± RBV as measured by the frequency of deaths, serious adverse events (SAEs), discontinuations due to Adverse Events (AEs), and severity Grade 3/4 laboratory abnormalities
Time frame: Up to post treatment Week 36

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2014.

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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

1 site 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, BMS-986094 and Ribavirin in people with Hepatitis C Virus, run by Bristol-Myers Squibb at 1 site in United States.

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 6 inclusion and 2 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: withdrawn, as of the sponsor's last update on 9 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

The study was withdrawn before enrolling participants, so there are no results.

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 SVR4 defined as HCV RNA < LOQ (25 IU/mL; detectable or undetectable) at 4 weeks post treatment to be evaluated in GT1 (naive and NR) subjects randomized to the 12-week treatment arm (arms 1a, 2a, 3a, 4a) (time frame: Follow up Week 4). 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 NCT01629732.

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 May 2014.