Hepatitis C VirusPhase 2HEPCATNCT01193361
Ph IIA Study (SOC +/- NS5B)
A Phase 2 study testing BMS-791325, Peg-interferon alfa-2a and Ribavirin in people with Hepatitis C Virus, run by Bristol-Myers Squibb at 10 sites in United States.
Trial summary
At least 1 dose of BMS-791325 can be identified which is safe, well tolerated, and efficacious when combined with peg-interferon alfa-2a (pegIFNα-2a)/ribavirin (RBV) for the treatment of treatment-naïve, chronically-infected hepatitis C virus (HCV) genotype 1 subjects Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis C Virus
- What is being tested?
- BMS-791325, Peg-interferon 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
- 39 participants
- Where
- 10 sitesUnited States
- Study dates
- Oct 2010to Nov 2012
- 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
- Subjects chronically infected with HCV genotype 1 as documented by: positive for anti-HCV antibody, HCV RNA, or a positive HCV genotype test at least 6 months prior to Screening, and positive for HCV RNA and anti-HCV antibody at Screening
- HCV RNA ≥ 10*5* IU/mL at Screening
- Less than 4 weeks total prior therapy with an IFN formulation (ie, IFNα, pegIFNα-2a), or RBV and no exposure to IFN or RBV within 24 weeks of Randomization
- Results of a biopsy obtained ≤ 24 months prior to Randomization showing no evidence of cirrhosis
- Body Mass Index (BMI) of 18 to 35 kg/m², inclusive. BMI = weight (kg)/ [height (m)]² at Screening
Who cannot join
- Liver transplant recipients
- Documented or suspected HCC by imaging or liver biopsy
- Evidence of a medical condition associated with chronic liver disease other than HCV (such as but not limited to: hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
- History of chronic hepatitis B virus (HBV) as documented by HBV serologies (eg. HBsAg-seropositive). Patients with resolved HBV infection may participate (eg. HBsAb-seropositive)
- Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Advanced Clinical Research Institute
Anaheim, California, 92801
The North Texas Research Institute
Arlington, Texas, 76012
Mercy Medical Center
Baltimore, Maryland, 21202
Digestive Disease Associates, P.A.
Baltimore, Maryland, 21229
Charlotte Gastroenterology & Hepatology, Pllc
Charlotte, North Carolina, 28207
Metropolitan Research
Fairfax, Virginia, 22031
Loyola University Medical Center
Maywood, Illinois, 60153
Alamo Medical Research
San Antonio, Texas, 78215
Claudia T. Martorell, Md, Llc
Springfield, Massachusetts, 01107
Options Health Research, Llc
Tulsa, Oklahoma, 74104
About this study
Official title: A Phase 2A Study of BMS-791325 in Combination With Peg Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naïve Subjects With Chronic Hepatitis C Virus Genotype 1 Infection
At least 1 dose of BMS-791325 can be identified which is safe, well tolerated, and efficacious when combined with peg-interferon alfa-2a (pegIFNα-2a)/ribavirin (RBV) for the treatment of treatment-naïve, chronically-infected hepatitis C virus (HCV) genotype 1 subjects
- Conditions
- Hepatitis C Virus
- Being tested
- BMS-791325, Placebo, Peg-interferon 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.
BMS-791325Drug
Tablets, Oral, 75 mg, twice daily, 4-48 weeks depending on response
BMS-791325Drug
Tablets, Oral, 150 mg, twice daily, 4-48 weeks depending on response
PlaceboDrug
Tablets, Oral, 0 mg, twice daily, 4-48 weeks depending on response
Peg-interferon alfa-2aDrug
Also called Pegasys
Syringe, Subcutaneous Injection, 180 µg, once weekly, 4-48 weeks depending on response
RibavirinDrug
Also called Copegus
Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 4-48 weeks depending on response
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - BMS-791325 plus peg-interferon alfa-2a and ribavirin | Experimental | Not described Receives: Drug: BMS-791325; Drug: Peg-interferon alfa-2a; Drug: Ribavirin |
| Arm 2 - BMS-791325 plus peg-interferon alfa-2a and ribavirin | Experimental | Not described Receives: Drug: BMS-791325; Drug: Peg-interferon alfa-2a; Drug: Ribavirin |
| Arm 3 - Placebo plus peg-interferon alfa-2a and ribavirin | Placebo comparator | Not described Receives: Drug: Placebo; Drug: Peg-interferon alfa-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: Formal analysis at week 4 (and upon occurrence)
Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
Measured: Formal analysis at week 12 (and upon occurrence)
Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
Measured: Formal analysis at week 24 post treatment (and upon occurrence)
Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
Measured: Formal analysis at week 48 post treatment (and upon occurrence)
Antiviral activity, as determined by the proportion subjects with eRVR
Measured: Week 4
Antiviral activity, as determined by the proportion subjects with eRVR
Measured: Week 12
Secondary outcomes (5)
Proportion of subjects with rapid virologic response (RVR), defined as undetectable HCV RNA
Measured: Week 4
Proportion of subjects with complete early virologic response (cEVR), defined as undetectable HCV RNA
Measured: Week 12
Proportions of subjects with a 12-week SVR (SVR12) and 24-week SVR (SVR24), defined as undetectable HCV RNA at off treatment follow-up
Measured: Week 12
Proportions of subjects with a 12-week SVR (SVR12) and 24-week SVR (SVR24), defined as undetectable HCV RNA at off treatment follow-up
Measured: Week 24
Resistant HCV variants associated with virologic failure
Measured: End of treatment (Week 48) or upon early discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionJun 2011
- Study completionNov 2012
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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01193361
- Sponsor's protocol ID
- AI443-012
- Acronym
- HEPCAT
- Status last verified
- Sep 2015
- First submitted
- 25 Aug 2010
- Last updated
- 9 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2A Study of BMS-791325 in Combination With Peg Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naïve Subjects With Chronic Hepatitis C Virus Genotype 1 Infection
- ClinicalTrials.gov ID
- NCT01193361
- Acronym / sponsor ID
- HEPCAT / AI443-012
- Conditions
- Hepatitis C Virus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 1 Sep 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.
At least 1 dose of BMS-791325 can be identified which is safe, well tolerated, and efficacious when combined with peg-interferon alfa-2a (pegIFNα-2a)/ribavirin (RBV) for the treatment of treatment-naïve, chronically-infected hepatitis C virus (HCV) genotype 1 subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - BMS-791325 plus peg-interferon alfa-2a and ribavirin | Experimental | Drug: BMS-791325, Drug: Peg-interferon alfa-2a, Drug: Ribavirin |
| Arm 2 - BMS-791325 plus peg-interferon alfa-2a and ribavirin | Experimental | Drug: BMS-791325, Drug: Peg-interferon alfa-2a, Drug: Ribavirin |
| Arm 3 - Placebo plus peg-interferon alfa-2a and ribavirin | Placebo comparator | Drug: Placebo, Drug: Peg-interferon alfa-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 (5 listed)
- Subjects chronically infected with HCV genotype 1 as documented by: positive for anti-HCV antibody, HCV RNA, or a positive HCV genotype test at least 6 months prior to Screening, and positive for HCV RNA and anti-HCV antibody at Screening
- HCV RNA ≥ 10*5* IU/mL at Screening
- Less than 4 weeks total prior therapy with an IFN formulation (ie, IFNα, pegIFNα-2a), or RBV and no exposure to IFN or RBV within 24 weeks of Randomization
- Results of a biopsy obtained ≤ 24 months prior to Randomization showing no evidence of cirrhosis
- Body Mass Index (BMI) of 18 to 35 kg/m², inclusive. BMI = weight (kg)/ [height (m)]² at Screening
Key exclusion criteria (5 listed)
- Liver transplant recipients
- Documented or suspected HCC by imaging or liver biopsy
- Evidence of a medical condition associated with chronic liver disease other than HCV (such as but not limited to: hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
- History of chronic hepatitis B virus (HBV) as documented by HBV serologies (eg. HBsAg-seropositive). Patients with resolved HBV infection may participate (eg. HBsAb-seropositive)
- Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment
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-791325Tablets, Oral, 75 mg, twice daily, 4-48 weeks depending on response | Drug | Arm 1 - BMS-791325 plus peg-interferon alfa-2a and ribavirin |
| BMS-791325Tablets, Oral, 150 mg, twice daily, 4-48 weeks depending on response | Drug | Arm 2 - BMS-791325 plus peg-interferon alfa-2a and ribavirin |
| PlaceboTablets, Oral, 0 mg, twice daily, 4-48 weeks depending on response | Drug | Arm 3 - Placebo plus peg-interferon alfa-2a and ribavirin |
| Peg-interferon alfa-2aAlso: PegasysSyringe, Subcutaneous Injection, 180 µg, once weekly, 4-48 weeks depending on response | Drug | Arm 1 - BMS-791325 plus peg-interferon alfa-2a and ribavirin, Arm 2 - BMS-791325 plus peg-interferon alfa-2a and ribavirin, Arm 3 - Placebo plus peg-interferon alfa-2a and ribavirin |
| RibavirinAlso: CopegusTablets, Oral, 1000 or 1200 mg based on weight, twice daily, 4-48 weeks depending on response | Drug | Arm 1 - BMS-791325 plus peg-interferon alfa-2a and ribavirin, Arm 2 - BMS-791325 plus peg-interferon alfa-2a and ribavirin, Arm 3 - Placebo plus peg-interferon alfa-2a and ribavirin |
Primary outcome
Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
Time frame: Formal analysis at week 4 (and upon occurrence)
Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
Time frame: Formal analysis at week 12 (and upon occurrence)
Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
Time frame: Formal analysis at week 24 post treatment (and upon occurrence)
Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
Time frame: Formal analysis at week 48 post treatment (and upon occurrence)
Antiviral activity, as determined by the proportion subjects with eRVR
Time frame: Week 4
Antiviral activity, as determined by the proportion subjects with eRVR
Time frame: Week 12
5 secondary outcomes
Proportion of subjects with rapid virologic response (RVR), defined as undetectable HCV RNA
Time frame: Week 4
Proportion of subjects with complete early virologic response (cEVR), defined as undetectable HCV RNA
Time frame: Week 12
Proportions of subjects with a 12-week SVR (SVR12) and 24-week SVR (SVR24), defined as undetectable HCV RNA at off treatment follow-up
Time frame: Week 12
Proportions of subjects with a 12-week SVR (SVR12) and 24-week SVR (SVR24), defined as undetectable HCV RNA at off treatment follow-up
Time frame: Week 24
Resistant HCV variants associated with virologic failure
Time frame: End of treatment (Week 48) or upon early discontinuation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2015.
Related trials for Hepatitis C Virus
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
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
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Not yet recruitingPhase 4
Combating Related Epidemics in HCV
HIV - Human Immunodeficiency Virus, Hepatitis B Virus (HBV)
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
10 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-791325, Peg-interferon alfa-2a and Ribavirin in people with Hepatitis C Virus, run by Bristol-Myers Squibb at 10 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 5 inclusion and 5 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 9 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 10 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: Formal analysis at week 4 (and upon occurrence)). 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 9 Oct 2015.