Hepatitis CPhase 3NCT01448044
Phase III BMS-790052 Add-On to Peg-Interferon Alfa-2a and Ribavirin in Naive Hepatitis C
A Phase 3 study testing BMS-790052 (NS5A Replication Complex Inhibitor), Pegylated-interferon alfa 2a and Ribavirin in people with Hepatitis C, run by Bristol-Myers Squibb at 26 sites in 7 countries.
Trial summary
The purpose of this study is to compare the sustained virologic response at post treatment Week 12 for each cohort (BMS-790052/Pegylated-interferon alfa 2a (pegIFNα-2a)/Ribavirin (RBV) versus placebo/PegIFNα-2a/RBV). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- BMS-790052 (NS5A Replication Complex Inhibitor), Pegylated-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
- 152 participants
- Where
- 26 sitesin 7 countries
- Study dates
- Dec 2011to Jan 2014
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants chronically infected with HCV Genotype 4
- HCV RNA viral load of ≥ 10,000 IU/mL
- No previous exposure to an interferon formulation, RBV or HCV direct antiviral agent
- Results of a liver biopsy obtained within three years prior to enrollment to demonstrate the absence of cirrhosis. Participants with compensated cirrhosis are permitted, however, and any prior biopsy is permitted
Who cannot join
- Evidence of decompensated liver disease
- Documented or suspected Hepatocellular carcinoma (HCC)
- Positive for Hepatitis B surface antigen (HBsAg) or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody at screening
Trial locations and contacts
26 sites in 7 countries.
26 sites in 7 countries
France11 sites
Local Institution
Bondy, 93143
Local Institution
Créteil, 94000
Local Institution
La Roche-sur-Yon, 85925
Local Institution
Marseille, 13285
Local Institution
Nice, 06202
Local Institution
Orléans, 45067
Local Institution
Paris, 75013
Local Institution
Paris, 75475
Local Institution
Strasbourg, 67091
Local Institution
Toulouse, 31059
Local Institution
Villejuif, 94804
United States4 sites
Metropolitan Research
Annandale, Virginia, 22003
University Gastroenterology
Providence, Rhode Island, 02905
Scti Research Foundation
San Clemente, California, 92673
Umass Memorial Medical Center
Worcester, Massachusetts, 01655
Spain4 sites
Local Institution
A Coruña, 15706
Local Institution
Barcelona, 08003
Local Institution
Barcelona, 08035
Local Institution
Madrid, 28046
United Kingdom3 sites
Local Institution
London, Greater London, SE5 9RS
Local Institution
London, Greater London, SW17 0QT
Local Institution
London, Greater London, W2 1NY
About this study
Official title: A Phase 3 Evaluation of BMS-790052 in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 4
The purpose of this study is to compare the sustained virologic response at post treatment Week 12 for each cohort (BMS-790052/Pegylated-interferon alfa 2a (pegIFNα-2a)/Ribavirin (RBV) versus placebo/PegIFNα-2a/RBV).
- Conditions
- Hepatitis C
- Being tested
- BMS-790052 (NS5A Replication Complex Inhibitor), Placebo matching BMS-790052, Pegylated-interferon alfa 2a, Ribavirin
- Keywords
- hepatitis C virus
- 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-790052 (NS5A Replication Complex Inhibitor)Drug
Placebo matching BMS-790052Drug
Pegylated-interferon alfa 2aDrug
Also called Pegasys
RibavirinDrug
Also called Copegus
| Study group | Role | What they receive |
|---|---|---|
| BMS-790052 + PegIFNα-2a + Ribavirin | Experimental | * BMS-790052 60 mg Tablets, Oral, once daily for 24 weeks
* PegIFNα-2a 180 μg Subcutaneous Injection, once weekly for 24 or 48 weeks depending on response
* Ribavirin 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) in the morning and 600 mg (3 tablets) in the evening, Oral for 24 or 48 weeks depending on response Receives: Drug: BMS-790052 (NS5A Replication Complex Inhibitor); Drug: Pegylated-interferon alfa 2a; Drug: Ribavirin |
| Placebo matching BMS-790052 + PegIFNα-2a + Ribavirin | Placebo comparator | * Placebo matching BMS-790052 0 mg Tablets, Oral, once daily for 48 weeks
* PegIFNα-2a 180 μg Subcutaneous Injection, once weekly for 48 weeks
* Ribavirin 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) in the morning and 600 mg (3 tablets) in the evening, Oral for 48 weeks Receives: Drug: Placebo matching BMS-790052; Drug: Pegylated-interferon 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 12 Week Sustained Virologic Response (SVR12)
Participants were assessed for sustained virologic response 12 weeks post treatment (SVR12) defined as hepatitis C virus (HCV) RNA levels < lower limit of quantitation (LLOQ was 25 IU/mL), target detected (TD) or target not detected (TND) at post-treatment Week 12.
Measured: Week 12 (Follow-up period)
Secondary outcomes (4)
Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ)
Participants who achieved HCV RNA levels below LLOQ ie, 25 international unit per milliliter (IU/mL). Participants in the placebo arm did not have visits beyond post treatment Week 24.
Measured: Treatment Weeks 1, 2, 4, 6, 8 and 12; Weeks 4 and 12; End of treatment (EOT); Post treatment Week 24; Post treatment Week 48
Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels
Participants who achieved HCV RNA undetectable ie, 10 international units per milliliter (IU/mL). Participants in the placebo arm did not have visits beyond post treatment Week 24.
Measured: Treatment Weeks 1, 2, 4, 6, 8 and 12; Weeks 4 and 12, End of treatment (EOT), Post treatment Week 24, Post treatment Week 48
Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) or Sustained Virologic Response at Follow-up Week 24 (SVR24) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene
Participants categorized into three genotypes based on SNPs in the IL28B gene were assessed for SVR12 and SVR24, defined as response in which hepatitis C virus RNA levels below lower limit of quantitation or below target detected or target not detected at follow-up Week 12 and Week 24 respectively.
Measured: Post Treatment Weeks 12, 24
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalisation.
Measured: From Day 1 (start of study treatment) up to Follow-up Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startDec 2011
- Primary completionOct 2013
- Study completionJan 2014
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 CStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 152 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
- NCT01448044
- Sponsor's protocol ID
- AI444-042
- Other IDs
- 2011-002793-23
- Status last verified
- Sep 2015
- First submitted
- 5 Oct 2011
- Last updated
- 12 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hezode C, Alric L, Brown A, Hassanein T, Rizzetto M, Buti M, Bourliere M, Thabut D, Molina E, Rustgi V, Samuel D, McPhee F, Liu Z, Yin PD, Hughes E, Treitel M; COMMAND-4 study team. Randomized controlled trial of the NS5A inhibitor daclatasvir plus pegylated interferon and ribavirin for HCV genotype-4 (COMMAND-4). Antivir Ther. 2015 Aug 27;21(3):195-205. doi: 10.3851/IMP2985. Online ahead of print.
PubMed 26313445
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Evaluation of BMS-790052 in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 4
- ClinicalTrials.gov ID
- NCT01448044
- Acronym / sponsor ID
- AI444-042
- Conditions
- Hepatitis C
- Keywords
- hepatitis C virus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 7 Oct 2011 (estimated)
- Results
- Posted 7 Sep 2015
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 compare the sustained virologic response at post treatment Week 12 for each cohort (BMS-790052/Pegylated-interferon alfa 2a (pegIFNα-2a)/Ribavirin (RBV) versus placebo/PegIFNα-2a/RBV).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMS-790052 + PegIFNα-2a + Ribavirin | Experimental | Drug: BMS-790052 (NS5A Replication Complex Inhibitor), Drug: Pegylated-interferon alfa 2a, Drug: Ribavirin* BMS-790052 60 mg Tablets, Oral, once daily for 24 weeks * PegIFNα-2a 180 μg Subcutaneous Injection, once weekly for 24 or 48 weeks depending on response * Ribavirin 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) in the morning and 600 mg (3 tablets) in the evening, Oral for 24 or 48 weeks depending on response |
| Placebo matching BMS-790052 + PegIFNα-2a + Ribavirin | Placebo comparator | Drug: Placebo matching BMS-790052, Drug: Pegylated-interferon alfa 2a, Drug: Ribavirin* Placebo matching BMS-790052 0 mg Tablets, Oral, once daily for 48 weeks * PegIFNα-2a 180 μg Subcutaneous Injection, once weekly for 48 weeks * Ribavirin 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) in the morning and 600 mg (3 tablets) in the evening, Oral for 48 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants chronically infected with HCV Genotype 4
- HCV RNA viral load of ≥ 10,000 IU/mL
- No previous exposure to an interferon formulation, RBV or HCV direct antiviral agent
- Results of a liver biopsy obtained within three years prior to enrollment to demonstrate the absence of cirrhosis. Participants with compensated cirrhosis are permitted, however, and any prior biopsy is permitted
Key exclusion criteria (3 listed)
- Evidence of decompensated liver disease
- Documented or suspected Hepatocellular carcinoma (HCC)
- Positive for Hepatitis B surface antigen (HBsAg) or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody at screening
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-790052 (NS5A Replication Complex Inhibitor) | Drug | BMS-790052 + PegIFNα-2a + Ribavirin |
| Placebo matching BMS-790052 | Drug | Placebo matching BMS-790052 + PegIFNα-2a + Ribavirin |
| Pegylated-interferon alfa 2aAlso: Pegasys | Drug | BMS-790052 + PegIFNα-2a + Ribavirin, Placebo matching BMS-790052 + PegIFNα-2a + Ribavirin |
| RibavirinAlso: Copegus | Drug | BMS-790052 + PegIFNα-2a + Ribavirin, Placebo matching BMS-790052 + PegIFNα-2a + Ribavirin |
Primary outcome
Percentage of Participants With 12 Week Sustained Virologic Response (SVR12)
Time frame: Week 12 (Follow-up period)
Participants were assessed for sustained virologic response 12 weeks post treatment (SVR12) defined as hepatitis C virus (HCV) RNA levels < lower limit of quantitation (LLOQ was 25 IU/mL), target detected (TD) or target not detected (TND) at post-treatment Week 12.
4 secondary outcomes
Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ)
Time frame: Treatment Weeks 1, 2, 4, 6, 8 and 12; Weeks 4 and 12; End of treatment (EOT); Post treatment Week 24; Post treatment Week 48
Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels
Time frame: Treatment Weeks 1, 2, 4, 6, 8 and 12; Weeks 4 and 12, End of treatment (EOT), Post treatment Week 24, Post treatment Week 48
Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) or Sustained Virologic Response at Follow-up Week 24 (SVR24) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene
Time frame: Post Treatment Weeks 12, 24
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died
Time frame: From Day 1 (start of study treatment) up to Follow-up Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26313445Hezode C, Alric L, Brown A, Hassanein T, Rizzetto M, Buti M, Bourliere M, Thabut D, Molina E, Rustgi V, Samuel D, McPhee F, Liu Z, Yin PD, Hughes E, Treitel M; COMMAND-4 study team. Randomized controlled trial of the NS5A inhibitor daclatasvir plus pegylated interferon and ribavirin for HCV genotype-4 (COMMAND-4). Antivir Ther. 2015 Aug 27;21(3):195-205. doi: 10.3851/IMP2985. Online ahead of print.
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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
26 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BMS-790052 (NS5A Replication Complex Inhibitor), Pegylated-interferon alfa 2a and Ribavirin in people with Hepatitis C, run by Bristol-Myers Squibb at 26 sites in 7 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 4 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 12 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 26 sites in France, United States, Spain, United Kingdom, Italy and 2 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 7 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 12 Week Sustained Virologic Response (SVR12) (time frame: Week 12 (Follow-up period)). 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 NCT01448044, 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 12 Oct 2015.