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Chronic Hepatitis CPhase 2NCT01359644

Study to Determine the Safety and Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) in Patients Who Have Previously Not Received the Standard of Care

A Phase 2 study testing PSI-7977, Daclatasvir and Ribavirin in people with Chronic Hepatitis C, run by Bristol-Myers Squibb at 18 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 the study is to determine whether therapy with the combination of PSI-7977 and daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C virus (HCV) infection when given for 12 or 24 weeks as measured by sustained virologic response with undetectable HCV RNA 12 weeks post… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Chronic Hepatitis C
What is being tested?
PSI-7977, Daclatasvir and Ribavirin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
18 sitesin 2 countries
Study dates
Jun 2011to Oct 2013
Phase
Phase 2
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women, ages 18 to 70 years.
  • Participants infected with hepatitis C virus (HCV) genotype 1, 2, or 3, with no previous exposure to an interferon formulation (ie, interferon-alpha, pegylated interferon-alpha) ribavirin, or other HCV-specific direct-acting antiviral (including daclatasvir and PSI-7977).
  • Patients should have chronic hepatitis C genotype 1a, 1b, 2, or 3 as documented by: positive test results for anti-HCV antibody; HCV RNA; or a HCV genotype at least 6 months prior to screening, and HCV RNA and anti-HCV antibody at the time of screening.

Who cannot join

  • Evidence of a medical condition associate with chronic liver disease other than HCV.
  • History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis.
  • History of hemophilia.
  • History of torsade de pointes.
  • Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment.
  • History of gastrointestinal disease or surgical procedure (except cholecystectomy).
Show all 10Show fewer
  • History of clinically significant cardiac disease.
  • Blood transfusion within 4 weeks prior to study drug administration.
  • Poor venous access.
  • Any other medical, psychiatric, and/or social reason which, in the opinion of the Investigator, would make the candidate inappropriate for participation in this study.

Trial locations and contacts

18 sites in 2 countries.

18 sites in 2 countries

United States17 sites

  • University Of Michigan Health System

    Ann Arbor, Michigan, 48109

  • Metropolitan Research

    Annandale, Virginia, 22003

  • University Of Colorado Denver & Hospital

    Aurora, Colorado, 80045

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Southern California Liver Centers

    Coronado, California, 92118

  • University Of Florida Hepatology

    Gainesville, Florida, 32610

  • Johns Hopkins University

    Lutherville, Maryland, 21093

  • Dean Clinic

    Madison, Wisconsin, 53715

  • Weill Cornell Medical College

    New York, New York, 10021

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • University Of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Alamo Medical Research

    San Antonio, Texas, 78215

  • Research And Education, Inc.

    San Diego, California, 92105

  • Miami Research Associates

    South Miami, Florida, 33143

  • Bronx Va Medical Center 3c Sub-J

    The Bronx, New York, 10468

  • Options Health Research, Llc

    Tulsa, Oklahoma, 74104

  • Healthcare Research Consultants

    Tulsa, Oklahoma, 74135

Other trials in United States

Puerto Rico1 site

  • Local Institution

    San Juan, 00927

Other trials in Puerto Rico

About this study

Official title: Parallel, Open-Label, Randomized Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of PSI-7977 in Combination With BMS-790052 With or Without Ribavirin in Treatment Naive Subjects Chronically Infected With Hepatitis C Virus Genotypes 1, 2, or 3

The purpose of the study is to determine whether therapy with the combination of PSI-7977 and daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C virus (HCV) infection when given for 12 or 24 weeks as measured by sustained virologic response with undetectable HCV RNA 12 weeks post treatment

Being tested
PSI-7977, Daclatasvir, Ribavirin
Medical subject headings
Hepatitis C, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PSI-7977Drug

    Tablets, oral, 400 mg, once daily

  • DaclatasvirDrug

    Also called BMS-790052

    Tablets, oral, 60 mg, once daily

  • RibavirinDrug

    Also called Copegus ®

    Tablets, oral, 200 mg

Study groups in NCT01359644
Study groupRoleWhat they receive
Treatment A: PSI-7977 + DaclatasvirExperimentalGenotype 1a or 1b
Receives: Drug: PSI-7977; Drug: Daclatasvir
Treatment B: PSI-7977 + DaclatasvirExperimentalGenotype 2 or 3
Receives: Drug: PSI-7977; Drug: Daclatasvir
Treatment C: PSI-7977 + DaclatasvirExperimentalGenotype 1a or 1b
Receives: Drug: PSI-7977; Drug: Daclatasvir
Treatment D: PSI-7977 + DaclatasvirExperimentalGenotype 2 or 3
Receives: Drug: PSI-7977; Drug: Daclatasvir
Treatment E: PSI-7977 + Daclatasvir + RibavirinExperimentalGenotype 1a or 1b
Receives: Drug: PSI-7977; Drug: Daclatasvir; Drug: Ribavirin
Treatment F: PSI-7977 + Daclatasvir+ RibavirinExperimentalGenotype 2 or 3
Receives: Drug: PSI-7977; Drug: Daclatasvir; Drug: Ribavirin
Treatment G: PSI-7977 + DaclatasvirExperimentalHepatitis C virus genotype 1, treatment-naive patients Genotype 1a or 1b
Receives: Drug: PSI-7977; Drug: Daclatasvir
Treatment H: PSI-7977 + BMS-790052 + RibavirinExperimentalHepatitis C virus genotype 1, treatment-naive patients Genotype 1a or 1b
Receives: Drug: PSI-7977; Drug: Daclatasvir; Drug: Ribavirin
Treatment I: PSI-7977 + DaclatasvirExperimentalPatients who experienced telaprevir/boceprevir treatment failure Genotype 1a or 1b
Receives: Drug: PSI-7977; Drug: Daclatasvir
Treatment J: PSI-7977 + Daclatasvir + RibavirinExperimentalPatients who experienced telaprevir/boceprevir treatment failure Genotype 1a or 1b
Receives: Drug: PSI-7977; Drug: Daclatasvir; Drug: Ribavirin

What is being measured

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

  1. Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12)

    SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected (ie, HCV RNA <25 IU/mL) at follow-up Week 12. DCV=daclatasvir, SOF=sofosbuvir.

    Measured: Follow-up Week 12

Secondary outcomes (6)

  1. Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24)

    SVR24 was defined as participant's hepatitis C virus RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 24. DCV=daclatasvir, SOF=sofosbuvir.

    Measured: Follow-up Week 24

  2. Percentage of Participants With Viral Breakthrough During the Treatment Period

    Viral breakthrough is defined as any confirmed increase in viral load ≥1 log from nadir or any confirmed hepatitis C virus RNA levels ≥25 IU/mL on or after Week 8.

    Measured: First dose of study drug (Day 1) up to end of treatment period (up to 12 or 24 weeks, depending on treatment group)

  3. Percentage of Participants Who Experienced Viral Relapse During Follow-up Period

    Viral relapse during follow-up is defined as any confirmed quantifiable hepatitis C virus (HCV) RNA ≥25 IU/mL with HCV RNA levels less than the lower limit of quantitation, target detected or target not detected, ie, HCV RNA <25 IU/mL at the end of treatment.

    Measured: Day 1 of follow-up period (Week 13 or 25, depending on treatment group) to end of follow-up period (up to 48 weeks)

  4. Change From Baseline in log10 Hepatitis C Virus (HCV) RNA at Follow-up Week 24

    Change from baseline in log10 HCV RNA at scheduled sampling time.

    Measured: Baseline, Follow-up week 24

  5. Number of Participants Who Died and With Serious Adverse Events (SAEs) and Grade 3-4 Adverse Events (AEs), During the Treatment Period Prior to Addition of Rescue Therapy

    AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting 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, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Very severe.

    Measured: First dose of study drug (Day 1) up to the start of rescue therapy (12 or 24 weeks, depending on treatment group)

  6. Number of Participants Who Died and With Serious Adverse Events (SAEs), Grade 3-4 Adverse Events (AEs), and Grade 3-4 Abnormalities on Laboratory Test Results During Follow-up Period

    AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting 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, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Very severe

    Measured: AEs: From Day 1 of follow-up period (Week 13 or 25) up to study discharge (up to 72 weeks). SAEs: From Day 1 of follow-up period (Week 13 or 25) up to 30 days after study discharge (up to 74 weeks)

Timeline

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

  1. First posted25 May 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionJan 2013
  4. Study completionOct 2013

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
350 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01359644
Sponsor's protocol ID
AI444-040
Status last verified
Sep 2015
First submitted
23 May 2011
Last updated
23 Oct 2015
Data monitoring committee
No

Publications

  • Sulkowski MS, Gardiner DF, Rodriguez-Torres M, Reddy KR, Hassanein T, Jacobson I, Lawitz E, Lok AS, Hinestrosa F, Thuluvath PJ, Schwartz H, Nelson DR, Everson GT, Eley T, Wind-Rotolo M, Huang SP, Gao M, Hernandez D, McPhee F, Sherman D, Hindes R, Symonds W, Pasquinelli C, Grasela DM; AI444040 Study Group. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med. 2014 Jan 16;370(3):211-21. doi: 10.1056/NEJMoa1306218.

    PubMed 24428467

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PSI-7977, Daclatasvir and Ribavirin in people with Chronic Hepatitis C, run by Bristol-Myers Squibb at 18 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 3 inclusion and 10 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 23 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 18 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 23 Oct 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 Sustained Virologic Response at Post Treatment Week 12 (SVR12) (time frame: Follow-up 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 NCT01359644, 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 23 Oct 2015.

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