Chronic Hepatitis C Virus Genotype 1Phase 2NCT01142700
A Study of BMS-824393 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype I
A Phase 2 study testing BMS-824393, Peginterferon Alpha-2a and Ribavirin in people with Chronic Hepatitis C Virus Genotype 1, run by Bristol-Myers Squibb at 11 sites in United States.
Trial summary
Based on 12-week on-treatment data, at least 1 dose of BMS-824393 can be identified which is safe, well tolerated, and has sufficient antiviral activity to progress to late stage clinical trials when combined with pegIFNα/RBV for treatment of chronically infected hepatitis C virus genotype 1 treatment-naive subjects. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis C Virus Genotype 1
- What is being tested?
- BMS-824393, 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
- 0 participants
- Where
- 11 sitesUnited States
- Study dates
- Jul 2010to Dec 2010
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Treatment-naive subjects with genotype 1 chronic HCV
- HCV RNA ≥ 100,000 IU/mL at screening
- Seronegative for HIV and HBsAg
- Liver biopsy within prior 2 years demonstrating no cirrhosis
Who cannot join
- Any evidence of liver disease other than hepatitis C
- Diagnosed or suspected hepatocellular carcinoma
- Laboratory values: neutrophil count < 1500 cells/μL, platelet count < 90,000/μL; Hemoglobin ≤ 12 g/dL (120g/L) for women and ≤ 13 g/dL (130 g/L) for men
- Cirrhosis
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Bach And Godofsky Infectious Diseases
Bradenton, Florida, 34209
Local Institution
Coronado, California, 92118
Baylor University Medical Center
Dallas, Texas, 75246
Maryland Digestive Disease Research
Laurel, Maryland, 20707
Gastrointestinal Specialists Of Georgia Pc
Mareitta, Georgia, 30060
Liver Institute Of Virginia Bon Secours Health System
Newport News, Virginia, 23602
Orlando Immunology Center
Orlando, Florida, 32803
Local Institution
Philadelphia, Pennsylvania, 19141
Research And Education, Inc.
San Diego, California, 92105
Vita Medical Center & Research Solutions, Inc.
Tamarac, Florida, 33319
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: A Randomized, Placebo-controlled, Phase 2a Study of BMS-824393 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype I
Based on 12-week on-treatment data, at least 1 dose of BMS-824393 can be identified which is safe, well tolerated, and has sufficient antiviral activity to progress to late stage clinical trials when combined with pegIFNα/RBV for treatment of chronically infected hepatitis C virus genotype 1 treatment-naive subjects.
- Conditions
- Chronic Hepatitis C Virus Genotype 1
- Being tested
- BMS-824393, Placebo, Peginterferon Alpha-2a, Ribavirin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-824393Drug
Capsule, Oral, 10 mg, once daily
BMS-824393Drug
Capsule, Oral, 30 mg, once daily
BMS-824393Drug
Capsule, Oral, 100 mg, once daily
PlaceboDrug
Capsule, Oral, 0 mg, once daily
Peginterferon Alpha-2aDrug
Also called Pegasys
Syringe, subcutaneous 180 mcg/0.5 mL, weekly
RibavirinDrug
Also called Copegus
Tablet, Oral, 400 or 600 mg based on weight (am) and 600 mg (pm), twice daily
| Study group | Role | What they receive |
|---|---|---|
| BMS-824393 (10mg) | Experimental | Plus Peginterferon Alfa-2a and Ribavirin
Day 1 - Week 12 Receives: Drug: BMS-824393; Drug: Peginterferon Alpha-2a; Drug: Ribavirin |
| BMS-824393 (30 mg) | Experimental | Plus Peginterferon Alfa-2a and Ribavirin
Day 1 - Week 12 Receives: Drug: BMS-824393; Drug: Peginterferon Alpha-2a; Drug: Ribavirin |
| BMS-824393 (100 mg) | Experimental | Plus Peginterferon Alfa-2a and Ribavirin
Day 1 - Week 12 Receives: Drug: BMS-824393; Drug: Peginterferon Alpha-2a; Drug: Ribavirin |
| Placebo | Placebo comparator | Plus Peginterferon Alfa-2a and Ribavirin
Day 1 - Week 12 Receives: Drug: Placebo; Drug: Peginterferon Alpha-2a; Drug: Ribavirin |
| Peginterferon alfa-2a plus Ribavirin | Other | Weeks 13 - 48 Receives: Drug: Peginterferon Alpha-2a; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
Measured: Week 4
Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
Measured: Week 12
Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
Measured: Week 24
Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
Measured: Week 48
Antiviral activity as determined by the proportion of subjects with extended rapid virologic response (eRVR) defined as undetectable HCV RNA
Measured: Week 4
Antiviral activity as determined by the proportion of subjects with extended rapid virologic response (eRVR) defined as undetectable HCV RNA
Measured: Week 12
Secondary outcomes (8)
Proportion of subjects with rapid virologic response (RVR), defined as undetectable RNA
Measured: Week 4
Proportion of subjects with complete early virologic response (cEVR), defined as undetectable HCV RNA
Measured: Week 12
Proportion of subjects with a sustained virologic response (SVR), defined as HCV RNA undetectable
Measured: Week 12 (SVR12)
Proportion of subjects with a sustained virologic response (SVR), defined as HCV RNA undetectable
Measured: Week 24 (SVR24)
Resistant variants associated with virologic failure
Measured: Week 4
Resistant variants associated with virologic failure
Measured: Week 12
Resistant variants associated with virologic failure
Measured: Follow up Week 12
Resistant variants associated with virologic failure
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis C Virus Genotype 1Studies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142700
- Sponsor's protocol ID
- AI451-004
- Other IDs
- 2010-018702-36
- Status last verified
- Mar 2011
- First submitted
- 3 Jun 2010
- Last updated
- 15 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Phase 2a Study of BMS-824393 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype I
- ClinicalTrials.gov ID
- NCT01142700
- Acronym / sponsor ID
- AI451-004
- Conditions
- Chronic Hepatitis C Virus Genotype 1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 11 Jun 2010 (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.
Based on 12-week on-treatment data, at least 1 dose of BMS-824393 can be identified which is safe, well tolerated, and has sufficient antiviral activity to progress to late stage clinical trials when combined with pegIFNα/RBV for treatment of chronically infected hepatitis C virus genotype 1 treatment-naive subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| BMS-824393 (10mg) | Experimental | Drug: BMS-824393, Drug: Peginterferon Alpha-2a, Drug: RibavirinPlus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12 |
| BMS-824393 (30 mg) | Experimental | Drug: BMS-824393, Drug: Peginterferon Alpha-2a, Drug: RibavirinPlus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12 |
| BMS-824393 (100 mg) | Experimental | Drug: BMS-824393, Drug: Peginterferon Alpha-2a, Drug: RibavirinPlus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12 |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Peginterferon Alpha-2a, Drug: RibavirinPlus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12 |
| Peginterferon alfa-2a plus Ribavirin | Other | Drug: Peginterferon Alpha-2a, Drug: RibavirinWeeks 13 - 48 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Treatment-naive subjects with genotype 1 chronic HCV
- HCV RNA ≥ 100,000 IU/mL at screening
- Seronegative for HIV and HBsAg
- Liver biopsy within prior 2 years demonstrating no cirrhosis
Key exclusion criteria (4 listed)
- Any evidence of liver disease other than hepatitis C
- Diagnosed or suspected hepatocellular carcinoma
- Laboratory values: neutrophil count < 1500 cells/μL, platelet count < 90,000/μL; Hemoglobin ≤ 12 g/dL (120g/L) for women and ≤ 13 g/dL (130 g/L) for men
- Cirrhosis
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-824393Capsule, Oral, 10 mg, once daily | Drug | BMS-824393 (10mg) |
| BMS-824393Capsule, Oral, 30 mg, once daily | Drug | BMS-824393 (30 mg) |
| BMS-824393Capsule, Oral, 100 mg, once daily | Drug | BMS-824393 (100 mg) |
| PlaceboCapsule, Oral, 0 mg, once daily | Drug | Placebo |
| Peginterferon Alpha-2aAlso: PegasysSyringe, subcutaneous 180 mcg/0.5 mL, weekly | Drug | BMS-824393 (100 mg), BMS-824393 (10mg), BMS-824393 (30 mg), Peginterferon alfa-2a plus Ribavirin, Placebo |
| RibavirinAlso: CopegusTablet, Oral, 400 or 600 mg based on weight (am) and 600 mg (pm), twice daily | Drug | BMS-824393 (100 mg), BMS-824393 (10mg), BMS-824393 (30 mg), Peginterferon alfa-2a plus Ribavirin, Placebo |
Primary outcome
Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
Time frame: Week 4
Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
Time frame: Week 12
Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
Time frame: Week 24
Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
Time frame: Week 48
Antiviral activity as determined by the proportion of subjects with extended rapid virologic response (eRVR) defined as undetectable HCV RNA
Time frame: Week 4
Antiviral activity as determined by the proportion of subjects with extended rapid virologic response (eRVR) defined as undetectable HCV RNA
Time frame: Week 12
8 secondary outcomes
Proportion of subjects with rapid virologic response (RVR), defined as undetectable RNA
Time frame: Week 4
Proportion of subjects with complete early virologic response (cEVR), defined as undetectable HCV RNA
Time frame: Week 12
Proportion of subjects with a sustained virologic response (SVR), defined as HCV RNA undetectable
Time frame: Week 12 (SVR12)
Proportion of subjects with a sustained virologic response (SVR), defined as HCV RNA undetectable
Time frame: Week 24 (SVR24)
Resistant variants associated with virologic failure
Time frame: Week 4
Resistant variants associated with virologic failure
Time frame: Week 12
Resistant variants associated with virologic failure
Time frame: Follow up Week 12
Resistant variants associated with virologic failure
Time frame: Week 24
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 15 Mar 2011.
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
11 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-824393, Peginterferon Alpha-2a and Ribavirin in people with Chronic Hepatitis C Virus Genotype 1, run by Bristol-Myers Squibb at 11 sites 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 4 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: withdrawn, as of the sponsor's last update on 15 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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. 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?
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?
Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs) (time frame: Week 4). The study lists 6 primary outcomes in all. 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 15 Mar 2011.