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

January 15, 2016 updated by: Southern Illinois University
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.

Study Overview

Status

Completed

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

37

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Illinois
      • Springfield, Illinois, United States, 62701
        • Southern Illinois University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 96 weeks post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 24, 48, and 96 weeks post treatment
Comparison of rates and severity of adverse events between the two study arms
24, 48, and 96 weeks post treatment
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.
24, 48, and 96 weeks post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Janak Koirala, MD, MPH, Southern Illinois University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

January 16, 2013

First Submitted That Met QC Criteria

January 17, 2013

First Posted (Estimate)

January 18, 2013

Study Record Updates

Last Update Posted (Estimate)

January 18, 2016

Last Update Submitted That Met QC Criteria

January 15, 2016

Last Verified

January 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis C Infection

3
Subscribe