Trial record 2 of 17 for:    "Noonan syndrome 5"

Ph IIA Study (SOC +/- NS5B) (HEPCAT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01193361
First received: August 25, 2010
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

At least 1 dose of BMS-791325 can be identified which is safe, well tolerated, and efficacious when combined with peg-interferon alfa-2a (pegIFNα-2a)/ribavirin (RBV) for the treatment of treatment-naïve, chronically-infected hepatitis C virus (HCV) genotype 1 subjects


Condition Intervention Phase
Hepatitis C Virus
Drug: BMS-791325
Drug: Placebo
Drug: Peg-interferon alfa-2a
Drug: Ribavirin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2A Study of BMS-791325 in Combination With Peg Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naïve Subjects With Chronic Hepatitis C Virus Genotype 1 Infection

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs) [ Time Frame: Formal analysis at week 4 (and upon occurrence) ] [ Designated as safety issue: Yes ]
  • Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs) [ Time Frame: Formal analysis at week 12 (and upon occurrence) ] [ Designated as safety issue: Yes ]
  • Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs) [ Time Frame: Formal analysis at week 24 post treatment (and upon occurrence) ] [ Designated as safety issue: Yes ]
  • Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs) [ Time Frame: Formal analysis at week 48 post treatment (and upon occurrence) ] [ Designated as safety issue: Yes ]
  • Antiviral activity, as determined by the proportion subjects with eRVR [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
  • Antiviral activity, as determined by the proportion subjects with eRVR [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of subjects with rapid virologic response (RVR), defined as undetectable HCV RNA [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Proportion of subjects with complete early virologic response (cEVR), defined as undetectable HCV RNA [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Proportions of subjects with a 12-week SVR (SVR12) and 24-week SVR (SVR24), defined as undetectable HCV RNA at off treatment follow-up [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Proportions of subjects with a 12-week SVR (SVR12) and 24-week SVR (SVR24), defined as undetectable HCV RNA at off treatment follow-up [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Resistant HCV variants associated with virologic failure [ Time Frame: End of treatment (Week 48) or upon early discontinuation ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: October 2010
Study Completion Date: November 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 - BMS-791325 plus peg-interferon alfa-2a and ribavirin Drug: BMS-791325
Tablets, Oral, 75 mg, twice daily, 4-48 weeks depending on response
Drug: Peg-interferon alfa-2a
Syringe, Subcutaneous Injection, 180 µg, once weekly, 4-48 weeks depending on response
Other Name: Pegasys
Drug: Ribavirin
Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 4-48 weeks depending on response
Other Name: Copegus
Experimental: Arm 2 - BMS-791325 plus peg-interferon alfa-2a and ribavirin Drug: BMS-791325
Tablets, Oral, 150 mg, twice daily, 4-48 weeks depending on response
Drug: Peg-interferon alfa-2a
Syringe, Subcutaneous Injection, 180 µg, once weekly, 4-48 weeks depending on response
Other Name: Pegasys
Drug: Ribavirin
Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 4-48 weeks depending on response
Other Name: Copegus
Placebo Comparator: Arm 3 - Placebo plus peg-interferon alfa-2a and ribavirin Drug: Placebo
Tablets, Oral, 0 mg, twice daily, 4-48 weeks depending on response
Drug: Peg-interferon alfa-2a
Syringe, Subcutaneous Injection, 180 µg, once weekly, 4-48 weeks depending on response
Other Name: Pegasys
Drug: Ribavirin
Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 4-48 weeks depending on response
Other Name: Copegus

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects chronically infected with HCV genotype 1 as documented by: positive for anti-HCV antibody, HCV RNA, or a positive HCV genotype test at least 6 months prior to Screening, and positive for HCV RNA and anti-HCV antibody at Screening
  • HCV RNA ≥ 10*5* IU/mL at Screening
  • Less than 4 weeks total prior therapy with an IFN formulation (ie, IFNα, pegIFNα-2a), or RBV and no exposure to IFN or RBV within 24 weeks of Randomization
  • Results of a biopsy obtained ≤ 24 months prior to Randomization showing no evidence of cirrhosis
  • Body Mass Index (BMI) of 18 to 35 kg/m², inclusive. BMI = weight (kg)/ [height (m)]² at Screening

Exclusion Criteria:

  • Liver transplant recipients
  • Documented or suspected HCC by imaging or liver biopsy
  • Evidence of a medical condition associated with chronic liver disease other than HCV (such as but not limited to: hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
  • History of chronic hepatitis B virus (HBV) as documented by HBV serologies (eg. HBsAg-seropositive). Patients with resolved HBV infection may participate (eg. HBsAb-seropositive)
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01193361

Locations
United States, California
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Maryland
Digestive Disease Associates, P.A.
Baltimore, Maryland, United States, 21229
Mercy Medical Center
Baltimore, Maryland, United States, 21202
United States, Massachusetts
Claudia T. Martorell, Md, Llc
Springfield, Massachusetts, United States, 01107
United States, North Carolina
Charlotte Gastroenterology & Hepatology, Pllc
Charlotte, North Carolina, United States, 28207
United States, Oklahoma
Options Health Research, Llc
Tulsa, Oklahoma, United States, 74104
United States, Texas
The North Texas Research Institute
Arlington, Texas, United States, 76012
Alamo Medical Research
San Antonio, Texas, United States, 78215
United States, Virginia
Metropolitan Research
Fairfax, Virginia, United States, 22031
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01193361     History of Changes
Other Study ID Numbers: AI443-012
Study First Received: August 25, 2010
Last Updated: June 17, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Ribavirin
Interferon-alpha
Peginterferon alfa-2a
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014