Ph IIA Study (SOC +/- NS5B)

NCT01193361 | Completed Phase 2

• 1 other identifier: AI443-012
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Hepatitis C Virus

Outcome Measures

Primary Outcomes (6)

• Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)

  Formal analysis at week 4 (and upon occurrence)

• Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)

  Formal analysis at week 12 (and upon occurrence)

• Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)

  Formal analysis at week 24 post treatment (and upon occurrence)

• Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)

  Formal analysis at week 48 post treatment (and upon occurrence)

• Antiviral activity, as determined by the proportion subjects with eRVR

  Week 4

• Antiviral activity, as determined by the proportion subjects with eRVR

  Week 12

Secondary Outcomes (5)

• Proportion of subjects with rapid virologic response (RVR), defined as undetectable HCV RNA

  Week 4

• Proportion of subjects with complete early virologic response (cEVR), defined as undetectable HCV RNA

  Week 12

• Proportions of subjects with a 12-week SVR (SVR12) and 24-week SVR (SVR24), defined as undetectable HCV RNA at off treatment follow-up

  Week 12

• Proportions of subjects with a 12-week SVR (SVR12) and 24-week SVR (SVR24), defined as undetectable HCV RNA at off treatment follow-up

  Week 24

• Resistant HCV variants associated with virologic failure

  End of treatment (Week 48) or upon early discontinuation

Study Arms (3)

Arm 1 - BMS-791325 plus peg-interferon alfa-2a and ribavirin

EXPERIMENTAL

Drug: BMS-791325; Drug: Peg-interferon alfa-2a; Drug: Ribavirin

Arm 2 - BMS-791325 plus peg-interferon alfa-2a and ribavirin

EXPERIMENTAL

Drug: BMS-791325; Drug: Peg-interferon alfa-2a; Drug: Ribavirin

Arm 3 - Placebo plus peg-interferon alfa-2a and ribavirin

PLACEBO COMPARATOR

Drug: Placebo; Drug: Peg-interferon alfa-2a; Drug: Ribavirin

Interventions

BMS-791325 DRUG

Tablets, Oral, 75 mg, twice daily, 4-48 weeks depending on response

Arm 1 - BMS-791325 plus peg-interferon alfa-2a and ribavirin

Placebo DRUG

Tablets, Oral, 0 mg, twice daily, 4-48 weeks depending on response

Arm 3 - Placebo plus peg-interferon alfa-2a and ribavirin

Peg-interferon alfa-2a DRUG

Syringe, Subcutaneous Injection, 180 µg, once weekly, 4-48 weeks depending on response

Also known as: Pegasys

Arm 1 - BMS-791325 plus peg-interferon alfa-2a and ribavirin; Arm 2 - BMS-791325 plus peg-interferon alfa-2a and ribavirin; Arm 3 - Placebo plus peg-interferon alfa-2a and ribavirin

Ribavirin DRUG

Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 4-48 weeks depending on response

Also known as: Copegus

Arm 1 - BMS-791325 plus peg-interferon alfa-2a and ribavirin; Arm 2 - BMS-791325 plus peg-interferon alfa-2a and ribavirin; Arm 3 - Placebo plus peg-interferon alfa-2a and ribavirin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (10)

Advanced Clinical Research Institute

Anaheim, California, 92801, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

Digestive Disease Associates, P.A.

Baltimore, Maryland, 21229, United States

Location

Claudia T. Martorell, Md, Llc

Springfield, Massachusetts, 01107, United States

Location

Charlotte Gastroenterology & Hepatology, Pllc

Charlotte, North Carolina, 28207, United States

Location

Options Health Research, Llc

Tulsa, Oklahoma, 74104, United States

Location

The North Texas Research Institute

Arlington, Texas, 76012, United States

Location

Alamo Medical Research

San Antonio, Texas, 78215, United States

Location

Metropolitan Research

Fairfax, Virginia, 22031, United States

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Hepatitis C

Interventions

8-cyclohexyl-N-((dimethylamino)sulfonyl)-1,1a,2,12b-tetrahydro-11-methoxy-1a-((3-methyl-3,8-diazabicyclo(3.2.1)oct-8-yl)carbonyl)cycloprop(d)indolo(2,1-a)(2)benzazepine-5-carboxamide; peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2010
• First Posted: September 1, 2010
• Study Start: October 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: November 1, 2012
• Last Updated: October 9, 2015

Record last verified: 2015-09

Locations

US (10)