Hepatitis CPhase 3COMMAND-AsiaNCT01797848
Efficacy and Safety Evaluation of a Treatment Consisting of Peg Interferon Alfa + Ribavirin + Daclatasvir in HCV Genotype 1 and 4 Treatment naïve Patients
A Phase 3 study testing Peginterferon alfa 2a, Ribavirin and Daclatasvir in people with Hepatitis C, run by Bristol-Myers Squibb.
Trial summary
The purpose of this study is to determine whether 24 week treatment with the Daclatasvir (DCV) in combination with Pegylated-interferon alfa 2a (pegIFNα-2a) and Ribavirin (RBV) is safe and demonstrates rate of Sustained Virologic Response at follow up week 24 (SVR24) (defined as undetectable HCV RNA at post-treatment… 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?
- Peginterferon alfa 2a, Ribavirin and Daclatasvir
- 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
- No sites listed yet
- Study dates
- Jun 2014to Nov 2016
- Phase
- Phase 3
- 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
- Patients chronically infected with Hepatitis C virus (HCV) GT 1 or 4
- HCV RNA viral load ≥ 10,000 IU/mL
- Naïve to prior treatment with any interferon formulation, Ribavirin (RBV) or HCV direct antiviral agent
- Patients with compensated cirrhosis are permitted
Who cannot join
- Infected with HCV other than GT 1 or 4
- Evidence of decompensated liver disease
- Documented or suspected Hepatocellular carcinoma (HCC) as evidenced by previously obtained imaging studies or liver biopsy
- Evidence of a medical condition contributing to chronic liver disease other than HCV
- History of chronic Hepatitis B virus (HBV) or Human immunodeficiency virus (HIV)
- Current or know history of cancer (except in situ carcinoma of cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment
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- Laboratory values:
- Hemoglobin < 12 g/dL (females) or < 13 g/dL (males)
- Platelets < 90 x 1000000000 cells/L
- Absolute neutrophil count (ANC) < 1.5 × 1000000000 cells/L
- Total bilirubin ≥ 34 µmol/L (unless due to Gilbert's disease)
About this study
Official title: A Phase 3 Randomized, Double Blind, Multi-National Evaluation of Daclatasvir in Combination With Peg Interferon Alfa-2a and Ribavirin in Treatment-Naive Subjects With Chronic Hepatitis C Genotypes 1 and 4
The purpose of this study is to determine whether 24 week treatment with the Daclatasvir (DCV) in combination with Pegylated-interferon alfa 2a (pegIFNα-2a) and Ribavirin (RBV) is safe and demonstrates rate of Sustained Virologic Response at follow up week 24 (SVR24) (defined as undetectable HCV RNA at post-treatment Week 24) that are non-inferior to 48 weeks of the dual combination therapy of pegIFNα-2a/RBV in a majority of study subjects
- Conditions
- Hepatitis C
- Being tested
- Peginterferon alfa 2a, Ribavirin, Placebo matching Daclatasvir, Daclatasvir
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon alfa 2aDrug
Also called Pegasys®
RibavirinDrug
Also called Copegus® (Taiwan, Korea and Singapore), Wei Lining (China)
Placebo matching DaclatasvirDrug
DaclatasvirDrug
Also called BMS-790052-05
| Study group | Role | What they receive |
|---|---|---|
| pegIFNα 2a + Ribavirin + Placebo | Experimental | pegIFNα 2a 180 µg, Solution for injection, Subcutaneous, Once weekly, 48 weeks
Ribavirin 200 mg Tablets, by mouth, 400-600mg AM, 600 mg PM, 48 weeks
Placebo 0 mg Tablets, by mouth, Once daily, 24 weeks Receives: Drug: Peginterferon alfa 2a; Drug: Ribavirin; Drug: Placebo matching Daclatasvir |
| pegIFNα 2a + Ribavirin + Daclatasvir | Experimental | pegIFNα 2a 180 µg, Solution for injection, Subcutaneous, Once weekly, 24 or 48 weeks depending on response
Ribavirin 1000-1200 mg Tablets, by mouth, 400-600mg AM, 600 mg PM, 24 or 48 weeks depending on response
Daclatasvir 60 mg Tablets, by mouth, Once daily, 24 weeks Receives: Drug: Peginterferon alfa 2a; Drug: Ribavirin; Drug: Daclatasvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Genotype 1 subjects with SVR24, defined as HCV RNA < Limit of quantification (LOQ) at follow-up Week 24 for each cohort
Measured: Week 24 post treatment follow up
Secondary outcomes (5)
Proportion of Genotype (GT) 4 subjects with SVR24
Measured: Week 24 post treatment follow up visit
Proportion of GT 1 & 4 subjects who achieve HCV RNA < LOQ or undetectable
Measured: Week 24 post treatment follow up visit and Week 48 post treatment follow up visit for subjects who achieve Virologic response [VR] (4&12)
Frequency of Serious Adverse Events (SAEs)/discontinuations due to Adverse Events (AEs)
Measured: Up to 48 weeks plus 30 days
Discontinuations due to Adverse Events (AEs)
Measured: Up to 48 weeks plus 7 days
Proportion of subjects with Sustained Virologic Response at follow up week 12 (SVR12) or SVR24 by rs12979860 Single nucleotide polymorphism (SNP) in the IL28B gene
Measured: Up to 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2013 (estimated)
- Study startJun 2014
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 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
- NCT01797848
- Sponsor's protocol ID
- AI444-047
- Acronym
- COMMAND-Asia
- Status last verified
- Nov 2013
- First submitted
- 21 Feb 2013
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized, Double Blind, Multi-National Evaluation of Daclatasvir in Combination With Peg Interferon Alfa-2a and Ribavirin in Treatment-Naive Subjects With Chronic Hepatitis C Genotypes 1 and 4
- ClinicalTrials.gov ID
- NCT01797848
- Acronym / sponsor ID
- COMMAND-Asia / AI444-047
- Conditions
- Hepatitis C
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 25 Feb 2013 (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 determine whether 24 week treatment with the Daclatasvir (DCV) in combination with Pegylated-interferon alfa 2a (pegIFNα-2a) and Ribavirin (RBV) is safe and demonstrates rate of Sustained Virologic Response at follow up week 24 (SVR24) (defined as undetectable HCV RNA at post-treatment Week 24) that are non-inferior to 48 weeks of the dual combination therapy of pegIFNα-2a/RBV in a majority of study subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pegIFNα 2a + Ribavirin + Placebo | Experimental | Drug: Peginterferon alfa 2a, Drug: Ribavirin, Drug: Placebo matching DaclatasvirpegIFNα 2a 180 µg, Solution for injection, Subcutaneous, Once weekly, 48 weeks Ribavirin 200 mg Tablets, by mouth, 400-600mg AM, 600 mg PM, 48 weeks Placebo 0 mg Tablets, by mouth, Once daily, 24 weeks |
| pegIFNα 2a + Ribavirin + Daclatasvir | Experimental | Drug: Peginterferon alfa 2a, Drug: Ribavirin, Drug: DaclatasvirpegIFNα 2a 180 µg, Solution for injection, Subcutaneous, Once weekly, 24 or 48 weeks depending on response Ribavirin 1000-1200 mg Tablets, by mouth, 400-600mg AM, 600 mg PM, 24 or 48 weeks depending on response Daclatasvir 60 mg Tablets, by mouth, Once daily, 24 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)
- Patients chronically infected with Hepatitis C virus (HCV) GT 1 or 4
- HCV RNA viral load ≥ 10,000 IU/mL
- Naïve to prior treatment with any interferon formulation, Ribavirin (RBV) or HCV direct antiviral agent
- Patients with compensated cirrhosis are permitted
Key exclusion criteria (11 listed)
- Infected with HCV other than GT 1 or 4
- Evidence of decompensated liver disease
- Documented or suspected Hepatocellular carcinoma (HCC) as evidenced by previously obtained imaging studies or liver biopsy
- Evidence of a medical condition contributing to chronic liver disease other than HCV
- History of chronic Hepatitis B virus (HBV) or Human immunodeficiency virus (HIV)
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 |
|---|---|---|
| Peginterferon alfa 2aAlso: Pegasys® | Drug | pegIFNα 2a + Ribavirin + Daclatasvir, pegIFNα 2a + Ribavirin + Placebo |
| RibavirinAlso: Copegus® (Taiwan, Korea and Singapore), Wei Lining (China) | Drug | pegIFNα 2a + Ribavirin + Daclatasvir, pegIFNα 2a + Ribavirin + Placebo |
| Placebo matching Daclatasvir | Drug | pegIFNα 2a + Ribavirin + Placebo |
| DaclatasvirAlso: BMS-790052-05 | Drug | pegIFNα 2a + Ribavirin + Daclatasvir |
Primary outcome
Proportion of Genotype 1 subjects with SVR24, defined as HCV RNA < Limit of quantification (LOQ) at follow-up Week 24 for each cohort
Time frame: Week 24 post treatment follow up
5 secondary outcomes
Proportion of Genotype (GT) 4 subjects with SVR24
Time frame: Week 24 post treatment follow up visit
Proportion of GT 1 & 4 subjects who achieve HCV RNA < LOQ or undetectable
Time frame: Week 24 post treatment follow up visit and Week 48 post treatment follow up visit for subjects who achieve Virologic response [VR] (4&12)
Frequency of Serious Adverse Events (SAEs)/discontinuations due to Adverse Events (AEs)
Time frame: Up to 48 weeks plus 30 days
Discontinuations due to Adverse Events (AEs)
Time frame: Up to 48 weeks plus 7 days
Proportion of subjects with Sustained Virologic Response at follow up week 12 (SVR12) or SVR24 by rs12979860 Single nucleotide polymorphism (SNP) in the IL28B gene
Time frame: Up to 72 weeks
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 25 Nov 2013.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Peginterferon alfa 2a, Ribavirin and Daclatasvir in people with Hepatitis C, run by Bristol-Myers Squibb.
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 11 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 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
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 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?
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 Genotype 1 subjects with SVR24, defined as HCV RNA < Limit of quantification (LOQ) at follow-up Week 24 for each cohort (time frame: Week 24 post treatment follow up). 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 25 Nov 2013.