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Completed

NCT Number: NCT01771653

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.

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Key information

Conditions

Hepatitis C Infection Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Southern Illinois University School of Medicine

Springfield, Illinois, 62701, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Adverse events

    Time frame: 24, 48, and 96 weeks post treatment

    Comparison of rates and severity of adverse events between the two study arms

  2. 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.

Sponsors and collaborators

Lead sponsor

Southern Illinois University

Other

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jan 18, 2013
Registry last updated
Jan 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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