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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01771653

Enrollment

Registered

2013-01-18

Start date

2011-09-30

Completion date

2015-07-31

Last updated

2016-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C Infection

Keywords

Hepatitis C infection, Hepatitis C Virus, HCV

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results