Hepatitis CPhase 3NCT01979939
UNITY 1: A Study of an Investigational Treatment Regimen of Daclatasvir (DCV) + Asunaprevir (ASV) + BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) for 12 Weeks for the Treatment of Chronic Hepatitis C Virus (HCV) Genotype 1 Infection in Non-cirrhotic Subjects
A Phase 3 study testing DCV/ASV/BMS-791325 in people with Hepatitis C, run by Bristol-Myers Squibb at 66 sites in 5 countries.
Trial summary
To demonstrate the effectiveness of DCV 3DAA fixed dose regimen in treatment naive and treatment experienced non-cirrhotic subjects 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?
- DCV/ASV/BMS-791325
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 66 sitesin 5 countries
- Study dates
- Dec 2013to Nov 2014
- 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
- Subjects chronically infected with HCV genotype 1
- HCV RNA ≥ 10,000 IU/mL at screening
- Treatment-naïve subjects with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), RBV, or HCV DAA (protease, polymerase inhibitor, etc.)
- Treatment-experienced subjects are eligible
Who cannot join
- Evidence of cirrhosis
- Liver or any other organ transplant
- Current or known history of cancer within 5 years prior to enrollment
- Documented or suspected HCC
- Evidence of decompensated liver
Trial locations and contacts
66 sites in 5 countries.
66 sites in 5 countries
United States42 sites
Mt Vernon Endoscopy Center
Alexandria, Virginia, 22306
Lehigh Valley Health Network
Allentown, Pennsylvania, 18102
Asheville Gastroenterology Associates, Pa
Asheville, North Carolina, 28801
University Of Colorado Denver & Hospital
Aurora, Colorado, 80045
Binghamton Gastroenterology Associates
Binghamton, New York, 13903
Digestive Disease Associates, P.A.
Catonsville, Maryland, 21228
University Of Chicago Medical Center
Chicago, Illinois, 60637
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Duke University Medical Center
Durham, North Carolina, 27710
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
Baylor St. Luke'S Medical Center
Houston, Texas, 77030
Indiana University Med Center
Indianapolis, Indiana, 46202
Borland-Groover Clinic
Jacksonville, Florida, 32256
Kansas City Care Clinic
Kansas City, Missouri, 64111
Kansas City Research Institute
Kansas City, Missouri, 64131
Scripps Clinic
La Jolla, California, 92037
Johns Hopkins Medical Institutions
Lutherville, Maryland, 21093
Dean Clinic
Madison, Wisconsin, 53715
Gastrointestinal Specialists Of Georgia
Marietta, Georgia, 30060
Quality Medical Research Pllc
Nashville, Tennessee, 37211
Weill Cornell Medical College
New York, New York, 10021
Bon Secours St. Mary'S Hospital Of Richmond, Inc.
Newport News, Virginia, 23602
Digestive And Liver Disease Specialists
Norfolk, Virginia, 23502
Henry Ford Health System
Novi, Michigan, 48377
Orlando Immunology Center
Orlando, Florida, 32803
Hospital Of The University Of Pennsylvania
Philadelphia, Pennsylvania, 19104
University Of Pittsburgh Medical Center, Ctr For Liver Diseases
Pittsburgh, Pennsylvania, 15213
Premier Medical Group Of The Hudson Valley, Pc
Poughkeepsie, New York, 12601
University Gastroenterology
Providence, Rhode Island, 02905
Texas Liver Institute
San Antonio, Texas, 78215
Medical Associates Research Group
San Diego, California, 92123
Quest Clinical Research
San Francisco, California, 94115
Miami Research Associates
South Miami, Florida, 33143
Washington University School Of Medicine
St Louis, Missouri, 63110
Carolinas Center For Liver Disease
Statesville, North Carolina, 28677
James J Peters Vamc
The Bronx, New York, 10468
Options Health Research, Llc
Tulsa, Oklahoma, 74104
Healthcare Research Consultants
Tulsa, Oklahoma, 74135
The Gastroenterology Group Of South Jersey
Vineland, New Jersey, 08360
Trial Management Associates, Llc
Wilmington, North Carolina, 28403
Digestive Health Specialists, Pa
Winston-Salem, North Carolina, 27103
Canada10 sites
Local Institution
Calgary, Alberta, T2N 4Z6
Local Institution
Hamilton, Ontario, L8V 1C3
Local Institution
Montreal, Quebec, H2L 4P9
Local Institution
Montreal, Quebec, H2X 2P4
Local Institution
Montreal, Quebec, H3A 1T1
Local Institution
Toronto, Ontario, M6H 3M1
Local Institution
Vancouver, British Columbia, V5Z 1H2
Local Institution
Vancouver, British Columbia, V6Z 2C7
Local Institution
Vancouver, British Columbia, V6Z 2K5
Local Institution
Victoria, British Columbia, V8V 3P9
Australia7 sites
Local Institution
Adelaide, South Australia, 5000
Local Institution
Clayton
Local Institution
Darlinghurst, New South Wales, 2010
Local Institution
Fitzroy, Victoria, 3065
Local Institution
Fremantle, Western Australia, 6959
Local Institution
Greenslopes, Queensland, 4120
Local Institution
Heidelberg, Victoria, 3084
France6 sites
Local Institution
Clichy, 92110
Local Institution
Limoges, 87042
Local Institution
Montpellier, 34295
Local Institution
Paris, 75679
Local Institution
Pessac, 33604
Local Institution
Vandœuvre-lès-Nancy, 54511
About this study
Official title: A Phase 3 Evaluation of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination in Non-cirrhotic Subjects With Genotype 1 Chronic Hepatitis C
To demonstrate the effectiveness of DCV 3DAA fixed dose regimen in treatment naive and treatment experienced non-cirrhotic subjects
- Conditions
- Hepatitis C
- Being tested
- DCV/ASV/BMS-791325
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCV/ASV/BMS-791325Drug
| Study group | Role | What they receive |
|---|---|---|
| A 1: DCV/ASV/BMS-791325 in treatment-naive subjects | Experimental | Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 12 weeks Receives: Drug: DCV/ASV/BMS-791325 |
| A 2: DCV/ASV/BMS-791325 in treatment-experienced subjects | Experimental | Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 12 weeks Receives: Drug: DCV/ASV/BMS-791325 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of treated subjects in the naive cohort with sustained virologic response (SVR) 12
SVR12 is defined as HCV ribonucleic acid (RNA) < limit of quantitation (LOQ) target detected or target not detected (LOQ TD/TND) at post treatment Week 12
Measured: Post-Treatment Week 12
Secondary outcomes (9)
Proportion of subjects in the experienced cohort with SVR12
Measured: Follow up Week 12
Proportion of subjects in each cohort who achieve HCV RNA <LOQ TD/TND
Measured: On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24)
Proportion of subjects in each cohort who achieve HCV RNA <LOQ TND
Measured: On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment weeks 4, 8, 12 and 24
Safety measured by frequency of serious AEs (SAEs) and discontinuations due to adverse events (AEs) through the end of treatment in each cohort
Measured: Up to post treatment week 4 (±7 days)
Proportion of anemia defined as Hg <10 g/dL on-treatment and Hg ≥10 g/dL at baseline , in each cohort
Measured: Up to post treatment week 4 (±7 days)
Rates of selected grade 3-4 lab abnormalities (hematologic and liver function) in each cohort
Measured: Up to post treatment week 4 (±7 days)
Proportion of subjects in each cohort achieving SVR12 associated with HCV geno subtype 1a vs 1b
Measured: Post treatment week 12
Proportion of subjects in each cohort achieving SVR12 associated with IL28B rs12979860 single nucleotide polymorphism (SNP) status (CC genotype or non-CC genotype)
Measured: Post treatment week 12
Proportion of subjects in each cohort achieving SVR12 associated with stage of liver fibrosis
Measured: Post treatment week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionAug 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 416 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
- NCT01979939
- Sponsor's protocol ID
- AI443-102
- Other IDs
- 2013-002468-20
- Status last verified
- Oct 2015
- First submitted
- 4 Nov 2013
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Poordad F, Sievert W, Mollison L, Bennett M, Tse E, Brau N, Levin J, Sepe T, Lee SS, Angus P, Conway B, Pol S, Boyer N, Bronowicki JP, Jacobson I, Muir AJ, Reddy KR, Tam E, Ortiz-Lasanta G, de Ledinghen V, Sulkowski M, Boparai N, McPhee F, Hughes E, Swenson ES, Yin PD; UNITY-1 Study Group. Fixed-dose combination therapy with daclatasvir, asunaprevir, and beclabuvir for noncirrhotic patients with HCV genotype 1 infection. JAMA. 2015 May 5;313(17):1728-35. doi: 10.1001/jama.2015.3860.
PubMed 25942723
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Evaluation of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination in Non-cirrhotic Subjects With Genotype 1 Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT01979939
- Acronym / sponsor ID
- AI443-102
- Conditions
- Hepatitis C
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 8 Nov 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.
To demonstrate the effectiveness of DCV 3DAA fixed dose regimen in treatment naive and treatment experienced non-cirrhotic subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A 1: DCV/ASV/BMS-791325 in treatment-naive subjects | Experimental | Drug: DCV/ASV/BMS-791325Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 12 weeks |
| A 2: DCV/ASV/BMS-791325 in treatment-experienced subjects | Experimental | Drug: DCV/ASV/BMS-791325Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 12 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)
- Subjects chronically infected with HCV genotype 1
- HCV RNA ≥ 10,000 IU/mL at screening
- Treatment-naïve subjects with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), RBV, or HCV DAA (protease, polymerase inhibitor, etc.)
- Treatment-experienced subjects are eligible
Key exclusion criteria (5 listed)
- Evidence of cirrhosis
- Liver or any other organ transplant
- Current or known history of cancer within 5 years prior to enrollment
- Documented or suspected HCC
- Evidence of decompensated liver
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 |
|---|---|---|
| DCV/ASV/BMS-791325 | Drug | A 1: DCV/ASV/BMS-791325 in treatment-naive subjects, A 2: DCV/ASV/BMS-791325 in treatment-experienced subjects |
Primary outcome
Proportion of treated subjects in the naive cohort with sustained virologic response (SVR) 12
Time frame: Post-Treatment Week 12
SVR12 is defined as HCV ribonucleic acid (RNA) < limit of quantitation (LOQ) target detected or target not detected (LOQ TD/TND) at post treatment Week 12
9 secondary outcomes
Proportion of subjects in the experienced cohort with SVR12
Time frame: Follow up Week 12
Proportion of subjects in each cohort who achieve HCV RNA <LOQ TD/TND
Time frame: On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24)
Proportion of subjects in each cohort who achieve HCV RNA <LOQ TND
Time frame: On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment weeks 4, 8, 12 and 24
Safety measured by frequency of serious AEs (SAEs) and discontinuations due to adverse events (AEs) through the end of treatment in each cohort
Time frame: Up to post treatment week 4 (±7 days)
Proportion of anemia defined as Hg <10 g/dL on-treatment and Hg ≥10 g/dL at baseline , in each cohort
Time frame: Up to post treatment week 4 (±7 days)
Rates of selected grade 3-4 lab abnormalities (hematologic and liver function) in each cohort
Time frame: Up to post treatment week 4 (±7 days)
Proportion of subjects in each cohort achieving SVR12 associated with HCV geno subtype 1a vs 1b
Time frame: Post treatment week 12
Proportion of subjects in each cohort achieving SVR12 associated with IL28B rs12979860 single nucleotide polymorphism (SNP) status (CC genotype or non-CC genotype)
Time frame: Post treatment week 12
Proportion of subjects in each cohort achieving SVR12 associated with stage of liver fibrosis
Time frame: Post treatment week 12
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 3 Nov 2015.
- Derived from this study: PubMed 25942723Poordad F, Sievert W, Mollison L, Bennett M, Tse E, Brau N, Levin J, Sepe T, Lee SS, Angus P, Conway B, Pol S, Boyer N, Bronowicki JP, Jacobson I, Muir AJ, Reddy KR, Tam E, Ortiz-Lasanta G, de Ledinghen V, Sulkowski M, Boparai N, McPhee F, Hughes E, Swenson ES, Yin PD; UNITY-1 Study Group. Fixed-dose combination therapy with daclatasvir, asunaprevir, and beclabuvir for noncirrhotic patients with HCV genotype 1 infection. JAMA. 2015 May 5;313(17):1728-35. doi: 10.1001/jama.2015.3860.
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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
66 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DCV/ASV/BMS-791325 in people with Hepatitis C, run by Bristol-Myers Squibb at 66 sites in 5 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 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 3 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in United States, Canada, Australia, France, Puerto Rico. 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 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 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?
Proportion of treated subjects in the naive cohort with sustained virologic response (SVR) 12 (time frame: Post-Treatment Week 12). 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 NCT01979939, 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 3 Nov 2015.