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

Sponsor

Southern Illinois University (Other)

Overall Status

Completed

CT.gov ID

NCT01771653

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Hepatitis C Infection

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 Design

Study Type:

Observational

Actual Enrollment :

37 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Sep 1, 2011

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Virologic Response [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.

Secondary Outcome Measures

Adverse events [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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