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Hepatitis CPhase 3NCT01973049

UNITY 2: A Study of an Investigational Treatment Regimen of DCV+ASV+BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) With or Without RBV for 12 Weeks for the Treatment of Chronic Hepatitis C Virus(HCV)Genotype 1 Infection in Subjects With Compensated Cirrhosis

A Phase 3 study testing Daclatasvir, Asunaprevir and BMS-791325 in people with Hepatitis C, run by Bristol-Myers Squibb at 49 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To demonstrate the effectiveness of DCV 3DAA fixed dose combination with or without Ribavirin in treatment naive 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?
Daclatasvir, Asunaprevir and BMS-791325
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
202 participants
Where
49 sitesin 4 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
  • Subjects with compensated cirrhosis
  • HCV RNA ≥ 10,000 IU/mL at screening
  • Treatment-naïve subjects with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), Ribavirin (RBV), or HCV Direct Acting Antivirals (DAA) (protease, polymerase inhibitor, etc.)
  • Treatment-experienced subjects are eligible including exposure to anti-HCV agents of a mechanistic class other than those contained in the Daclatasvir (DCV) / Asunaprevir (ASV) /BMS-791325 triple regimen is permitted. Examples of permitted agents include, but are not limited to nucleoside/nucleotide inhibitors of nonstructural protein 5B (NS5B) polymerase, inhibitors of cyclophilin, or inhibitors of microRNA.

Who cannot join

  • Subjects without cirrhosis
  • Liver or any other organ transplant
  • Current or known history of cancer within 5 years prior to screening
  • Documented or suspected hepatocellular carcinoma(HCC)
  • Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy

Trial locations and contacts

49 sites in 4 countries.

49 sites in 4 countries

United States26 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

  • University Of Chicago

    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

  • Advanced Liver Therapies

    Houston, Texas, 77030

  • Indiana University Health

    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

  • 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

  • Digestive And Liver Disease Specialists

    Norfolk, Virginia, 23502

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • 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

  • Carolinas Center For Liver Disease

    Statesville, North Carolina, 28677

Other trials in United States

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

Other trials in Canada

Australia7 sites

  • Local Institution

    Adelaide, South Australia, 5000

  • Local Institution

    Clayton, Victoria, 3168

  • Local Institution

    Darlinghurst, New South Wales, 2010

  • Local Institution

    Fitzroy, Victoria, 3065

  • Local Institution

    Fremantle, Western Australia, 6160

  • Local Institution

    Greenslopes, Queensland, 4120

  • Local Institution

    Heidelberg, Victoria, 3084

Other trials in Australia

France6 sites

  • Local Institution

    Créteil, 94010

  • Local Institution

    Marseille, 13285

  • Local Institution

    Montpellier, 34000

  • Local Institution

    Nice, 06202

  • Local Institution

    Paris, 75013

  • Local Institution

    Paris, 75571

Other trials in France

About this study

Official title: A Phase 3 Evaluation of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination in Subjects With Genotype 1 Chronic Hepatitis C and Compensated Cirrhosis

To demonstrate the effectiveness of DCV 3DAA fixed dose combination with or without Ribavirin in treatment naive cirrhotic subjects.

Read the detailed description

Masking is Double blind for RBV: two or more parties are unaware of the intervention assignment.

Conditions
Hepatitis C
Being tested
Daclatasvir, Asunaprevir, BMS-791325, Ribavirin, Placebo matching 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.

  • DaclatasvirDrug

    Also called BMS-790052

  • AsunaprevirDrug

    Also called BMS-650032

  • BMS-791325Drug

  • RibavirinDrug

    Also called Ribasphere®

  • Placebo matching RibavirinDrug

Study groups in NCT01973049
Study groupRoleWhat they receive
A1: DCV/ASV/BMS-791325+Placebo matching RBV (naive)ExperimentalTriple fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg, BMS-791325 75 mg) tablet orally twice a day for 12 weeks Placebo matching Ribavirin 0mg tablet orally twice a day for 12 weeks
Receives: Drug: Daclatasvir; Drug: Asunaprevir; Drug: BMS-791325; Drug: Placebo matching Ribavirin
A2: DCV/ASV/BMS-791325 + RBV (naive)ExperimentalTriple fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg, BMS-791325 75 mg) tablet orally twice a day for 12 weeks Ribavirin 200mg tablet orally twice a day for 12 weeks
Receives: Drug: Daclatasvir; Drug: Asunaprevir; Drug: BMS-791325; Drug: Ribavirin
A3: DCV/ASV/BMS-791325+Placebo matching RBV (experienced)ExperimentalTriple fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg, BMS-791325 75 mg) tablet orally twice a day for 12 weeks Placebo matching Ribavirin 0 mg tablet orally twice a day for 12 weeks
Receives: Drug: Daclatasvir; Drug: Asunaprevir; Drug: BMS-791325; Drug: Placebo matching Ribavirin
A4: DCV/ASV/BMS-791325 + RBV (experienced)ExperimentalTriple fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg, BMS-791325 75 mg) tablet orally twice a day for 12 weeks Ribavirin 200 mg tablet orally twice a day for 12 weeks, Weight based dosing: If < 75 kg, 1000 mg per day (two 200 mg tablets in AM and three 200 mg tablets in PM); if ≥ 75 kg, 1200 mg per day (three 200 mg tablets in AM and three 200 mg tablets in PM), AM=in the morning, PM=in the evening
Receives: Drug: Daclatasvir; Drug: Asunaprevir; Drug: BMS-791325; Drug: Ribavirin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of treated subjects in each of the naive arms with sustained virologic response (SVR12)

    SVR12 is defined as Hepatitis C virus ribonucleic acid (HCV RNA) < Limit of Quantification (LOQ) target detected or target not detected (LOQ TD/TND)

    Measured: Post treatment 12 week

Secondary outcomes (8)

  1. Proportion of treated subjects in each of the experienced arms with SVR12

    Measured: Post treatment 12 Week

  2. Proportion of subjects in each arm who achieve HCV RNA < LOQ TD/TND

    Measured: Weeks: 1, 2, 4, 6, 8, and 12; Post treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24)

  3. Proportion of subjects in each arm who achieve HCV RNA < LOQ TND

    Measured: Weeks: 1, 2, 4, 6, 8, and 12; Post treatment Weeks 4 (SVR4), 8 (SVR8), 12 (SVR12) and 24 (SVR24)

  4. Safety as measured by frequency of Serious Adverse Events(SAEs)and discontinuations due to Adverse Events(AEs)

    Measured: Up to end of treatment (week 12) + 7 days

  5. Proportion of subjects with anemia defined as Hg < 10 g/dL on-treatment and Hg ≥ 10 g/dL at baseline in each arm within each cohort

    Measured: Up to end of treatment (week 12) + 7 days

  6. Differences in rates of selected Grade 3 - 4 laboratory test result abnormalities

    Measured: Up to end of treatment (week 12) + 7 days

  7. Proportion of subjects achieving SVR12 associated with HCV geno subtype 1a vs 1b

    Measured: Post treatment 12 Week

  8. Proportion of subjects in each arm achieving SVR12 associated with IL28B rs12979860 single nucleotide polymorphism(SNP) status (CC genotype or non-CC genotype)

    Measured: Post treatment 12 Week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2013 (estimated)
  2. Study startDec 2013
  3. Primary completionAug 2014
  4. Study completionNov 2014

Resources

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, Care provider, Investigator
Enrolment
202 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01973049
Sponsor's protocol ID
AI443-113
Other IDs
2013-002458-66
Status last verified
Sep 2015
First submitted
25 Oct 2013
Last updated
9 Oct 2015
Results posted
No
Data monitoring committee
No

Publications

  • Muir AJ, Poordad F, Lalezari J, Everson G, Dore GJ, Herring R, Sheikh A, Kwo P, Hezode C, Pockros PJ, Tran A, Yozviak J, Reau N, Ramji A, Stuart K, Thompson AJ, Vierling J, Freilich B, Cooper J, Ghesquiere W, Yang R, McPhee F, Hughes EA, Swenson ES, Yin PD. Daclatasvir in combination with asunaprevir and beclabuvir for hepatitis C virus genotype 1 infection with compensated cirrhosis. JAMA. 2015 May 5;313(17):1736-44. doi: 10.1001/jama.2015.3868.

    PubMed 25942724

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Daclatasvir, Asunaprevir and BMS-791325 in people with Hepatitis C, run by Bristol-Myers Squibb at 49 sites in 4 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 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 49 sites in United States, Canada, Australia, France. 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 each of the naive arms with sustained virologic response (SVR12) (time frame: Post treatment 12 week). 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 NCT01973049, 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 9 Oct 2015.

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