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Comparison of Two Triple Regimens for Treatment and Retreatment of Chronic Hepatitis C Infection

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ClinicalTrials.gov Identifier: NCT01771653
Recruitment Status : Completed
First Posted : January 18, 2013
Last Update Posted : January 18, 2016
Sponsor:
Information provided by (Responsible Party):
Southern Illinois University

January 16, 2013
January 18, 2013
January 18, 2016
September 2011
July 2015   (Final data collection date for primary outcome measure)
Virologic Response [ Time Frame: up to 96 weeks post treatment ]
Sustained Virologic Response (SVR) rates will be compared between the two arms of treatment through measured HCV RNA levels after 24 weeks, 48 weeks and 96 weeks after completion of treatment.
Same as current
Complete list of historical versions of study NCT01771653 on ClinicalTrials.gov Archive Site
  • Adverse events [ Time Frame: 24, 48, and 96 weeks post treatment ]
    Comparison of rates and severity of adverse events between the two study arms
  • Effect of baseline variables on treatment outcome [ Time Frame: 24, 48, and 96 weeks post treatment ]
    Analyze the effects of baseline variables on treatment outcome between the two groups- age, race, social economic status.
Same as current
Not Provided
Not Provided
 
Comparison of Two Triple Regimens for Treatment and Retreatment of Chronic Hepatitis C Infection
Comparison of Two Triple Regimens for Treatment and Retreatment of Chronic Hepatitis C Infection
The purpose of this observational study is to compare two approved treatment regimen(s) containing boceprevir and telaprevir, as part of standard of care for the treatment of hepatitis C.
The objective of the study is to compare the effect of adding 2 oral hepatitis C virus (HCV) protease inhibitors, telaprevir versus boceprevir, as part of current standard treatment regimen with (pegylated-interferon-alpha + ribavirin) for HCV Genotype-1 infection. Data will be obtained from medical records of consenting patients.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Population of adults aged 18-64 years, diagnosed with HCV genotype 1, with an HCV RNA >100,000. They should have had a liver biopsy within 5 years before enrollment. Lab work to determine eligibility includes an absolute neutrophil count of at least 1200 per cubic millimeter, a platelet count of at least 90,000 per cubic millimeter and a hemoglobin level of at least 12 g per deciliter
Hepatitis C Infection
Not Provided
  • Previously treated
    Data from patients who were previously treated with Peg, interferon (IFN), alfa, and ribavirin
  • Previously untreated
    Records of patients who have never received anti-HCV treatment.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
108
July 2015
July 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age - 18-64 years
  • HCV genotype 1
  • HCV RNA >100,000
  • Liver biopsy within 5 years before enrollment
  • Absolute neutrophil count of at least 1200 per cubic millimeter
  • Platelet count of at least 90,000 per cubic millimeter
  • Hemoglobin level of at least 12 g per deciliter
  • Signed informed consent and Health Insurance Portability and Accountability Act (HIPAA) forms

Exclusion Criteria:

  • HCV genotypes other than genotype 1
  • Immunocompromised conditions including HIV, transplant or immunosuppressive drugs
  • Decompensated liver disease or hepatocellular carcinoma
  • Any other types of active cancer
  • Active autoimmune disorders
  • Major psychiatric disorders
  • Active drug or alcohol use
  • Pregnancy or lactation
  • Patients with allergy to any of the drugs used in this study
  • Drugs that may interact with boceprevir or telaprevir as listed in the package insert
Sexes Eligible for Study: All
18 Years to 64 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01771653
KOI-SIUSOM-12-002
No
Not Provided
Not Provided
Southern Illinois University
Southern Illinois University
Not Provided
Principal Investigator: Janak Koirala, MD, MPH Southern Illinois University School of Medicine
Southern Illinois University
January 2016