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Hepatitis CPhase 3NCT01389323

BMS-790052 (Daclatasvir) Plus Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Black/African-Americans, Latinos and White/Caucasians With Hepatitis C

A Phase 3 study testing Daclatasvir, Peg-Interferon Alfa-2a and Ribavirin in people with Hepatitis C, run by Bristol-Myers Squibb at 36 sites in 2 countries.

Completed

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

Official record
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Trial summary

The purpose of this study is to compare the rates of sustained virologic response in each cohort (Black-African Americans, Latinos) in this study to historical rate. 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, Peg-Interferon Alfa-2a and Ribavirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
448 participants
Where
36 sitesin 2 countries
Study dates
Sep 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 Hepatitis C virus (HCV) genotype 1
  • HCV RNA viral load of ≥10,000 IU/mL at screening
  • No previous exposure to interferon formulation, ribavirin or HCV direct antiviral agent
  • Self-described as Black-African American, Latino or White-Caucasian
  • Results of a liver biopsy obtained ≤36 months prior to first treatment compensated cirrhotics with HCV liver biopsy from any time prior to first treatment.
  • Compensated cirrhotics were capped at approximately 25%

Who cannot join

  • Evidence of decompensated liver disease
  • Documented or suspected Hepatocellular carcinoma (HCC)
  • Positive for Hepatitis B or HIV 1/HIV 2 antibody at screening

Trial locations and contacts

36 sites in 2 countries.

36 sites in 2 countries

United States35 sites

  • Metropolitan Research

    Annandale, Virginia, 22003

  • Texas Clinical Research Institute

    Arlington, Texas, 76012

  • Atlanta Medical Center

    Atlanta, Georgia, 30312

  • The Emory Clinic

    Atlanta, Georgia, 30322

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Digestive Disease Associates, P.A.

    Baltimore, Maryland, 21229

  • University Of North Carolina At Chapel Hill School Of Med

    Chapel Hill, North Carolina, 27599

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • Baylor College Of Medicine

    Houston, Texas, 77030

  • Liver Associates Of Texas

    Houston, Texas, 77030

  • Research Specialists Of Texas

    Houston, Texas, 77030

  • Va Long Beach Healthcare System - 11

    Long Beach, California, 90822

  • Axis Clinical Trials

    Los Angeles, California, 90036

  • Greater Los Angeles Healthcare System

    Los Angeles, California, 90073

  • Miami V.A. Healthcare System

    Maimi, Florida, 33125

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • University Of Miami

    Miami, Florida, 33136

  • Alabama Liver & Digestive Specialists (Alds)

    Montgomery, Alabama, 36116

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112

  • Digestive Health Center

    Ocean Springs, Mississippi, 39564

  • Florida Hospital Transplant Center

    Orlando, Florida, 32804

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Mcguire D V A M C

    Richmond, Virginia, 23249

  • University Of California, Davis Medical Center

    Sacramento, California, 95817

  • Texas Liver Institute

    San Antonio, Texas, 78215

  • Brooke Army Medical Center

    San Antonio, Texas, 78234

  • Ucsd Antiviral Research Center (Avrc)

    San Diego, California, 92103

  • Precision Research Institute, Llc

    San Diego, California, 92115

  • Medical Associates Research Group, Inc

    San Diego, California, 92123

  • The Research Institute

    Springfield, Massachusetts, 01105

  • Carolinas Center For Liver Disease

    Statesville, North Carolina, 28677

  • Infectious Disease Research Institute, Inc

    Tampa, Florida, 33614

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • South Florida Center Of Gastroenterology, P.A.

    Wellington, Florida, 33414

  • Triple O Research Institute, P.A.

    West Palm Beach, Florida, 33401

Other trials in United States

Puerto Rico1 site

  • Local Institution

    San Juan, 00927

Other trials in Puerto Rico

About this study

Official title: Open-Label, Single Arm Evaluation of BMS-790052 (Daclatasvir) in Combination With Peg-Interferon Alfa-2a and Ribavirin in Black-African Americans, Latinos and White-Caucasians With Chronic Hepatitis C Genotype 1 Infection

The purpose of this study is to compare the rates of sustained virologic response in each cohort (Black-African Americans, Latinos) in this study to historical rate.

Conditions
Hepatitis C
Being tested
Daclatasvir, 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.

  • DaclatasvirDrug

    Also called BMS-790052

    Tablet, Oral, 60 mg, once daily, 24 weeks

  • Peg-Interferon Alfa-2aDrug

    Also called Pegasys

    Syringe, Subcutaneous Injection, 180 μg, Once weekly, 24 or 48 weeks depending on response

  • RibavirinDrug

    Also called Copegus

    Tablet, Oral, 1000 or 1200 mg based on weight, Twice daily, 24 or 48 weeks depending on response

Study groups in NCT01389323
Study groupRoleWhat they receive
Arm 1: Daclatasvir + Peg-Interferon Alfa-2a + RibavirinExperimentalNot described
Receives: Drug: Daclatasvir; Drug: Peg-Interferon Alfa-2a; Drug: Ribavirin

What is being measured

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

  1. Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12)

    SVR12 was defined as Hepatitis C Virus (HCV) RNA levels <lower limit of quantitation (LLOQ), (target detected or target not detected) at Post-treatment Week 12. The limit of detection for HCV RNA was 10 IU/mL and the LLOQ was 25 IU/mL. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.

    Measured: Post-treatment Week 12

Secondary outcomes (4)

  1. Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) With rs12979860 Single Nucleotide Polymorphisms at Baseline in the Interleukin-28B Gene

    SVR12 was defined as Hepatitis C Virus (HCV) RNA levels <lower limit of quantitation (LLOQ), (target detected or target not detected) at Post-treatment Week 12. The limit of detection for HCV RNA was 10 IU/mL and the LLOQ was 25 IU/mL. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.

    Measured: Post-treatment Week 12

  2. Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points

    The limit of detection for HCV RNA levels was 10 IU/mL and the LLOQ was 25 IU/mL. Data for post-treatment Weeks 36 and 48 were based on participants who had achieved virologic response (defined as HCV RNA levels <LLOQ, target not detected) at both Weeks 4 and 12, and completed 24 weeks of study treatment. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.

    Measured: Weeks 1, 2, 4, 6, 8, 12; both Weeks 4 and 12; end-of-treatment (up to 48 weeks), or post-treatment Week 24

  3. Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points

    The limit of detection for HCV RNA levels was 10 IU/mL and the LLOQ was 25 IU/mL. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.

    Measured: Weeks 1, 2, 4, 6, 8, 12; both Weeks 4 and 12; end-of-treatment (up to 48 weeks), or post-treatment Weeks 12 and 24

  4. Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died

    An 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 hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug. For analysis purpose, participants were assigned to following 4 race/ethnicity cohorts: Black/African American, White/Caucasian, Latino and Non-Latino. Some participants were represented in more than one race/ethnicity cohort.

    Measured: From first dose to last dose plus 7 days (treatment period [TP]) through 48 weeks after the end of TP (follow-up period [FUP])

Timeline

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

  1. First posted8 Jul 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionSep 2013
  4. Study completionJan 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
448 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01389323
Sponsor's protocol ID
AI444-038
Status last verified
Sep 2015
First submitted
6 Jul 2011
Last updated
12 Oct 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Daclatasvir, Peg-Interferon Alfa-2a and Ribavirin in people with Hepatitis C, run by Bristol-Myers Squibb at 36 sites in 2 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 6 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 36 sites in United States, 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?

Yes. Results are posted in the registry (first posted 16 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 Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) (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 NCT01389323.

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.

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