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

This study is currently recruiting participants.
Verified January 2013 by Southern Illinois University
Sponsor:
Information provided by (Responsible Party):
Southern Illinois University
ClinicalTrials.gov Identifier:
NCT01771653
First received: January 16, 2013
Last updated: January 17, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition
Hepatitis C Infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Two Triple Regimens for Treatment and Retreatment of Chronic Hepatitis C Infection

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Southern Illinois University:

Primary Outcome Measures:
  • Virologic Response [ Time Frame: up to 96 weeks post treatment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Adverse events [ Time Frame: 24, 48, and 96 weeks post treatment ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Analyze the effects of baseline variables on treatment outcome between the two groups- age, race, social economic status.


Estimated Enrollment: 108
Study Start Date: September 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Previously treated
Data from patients who were previously treated with Peg- IFN- alfa and ribavarin
Previously untreated
Records of patients who have never received anti-HCV treatment.

Detailed Description:

The objective of the study is to compare the effect of adding 2 oral 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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01771653

Contacts
Contact: Jennifer Andoh 217-545-9491 jandoh@siumed.edu

Locations
United States, Illinois
Southern Illinois University School of Medicine Recruiting
Springfield, Illinois, United States, 62701
Sponsors and Collaborators
Southern Illinois University
Investigators
Principal Investigator: Janak Koirala, MD, MPH Southern Illinois University School of Medicine
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site
WHO. Global Alert and Response: Hepatitis.  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Southern Illinois University
ClinicalTrials.gov Identifier: NCT01771653     History of Changes
Other Study ID Numbers: KOI-SIUSOM-12-002
Study First Received: January 16, 2013
Last Updated: January 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Southern Illinois University:
Hepatitis C infection
Hepatitis C Virus
HCV

Additional relevant MeSH terms:
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis A
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
 Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on May 19, 2013