Clinical trial NCT01771653: Comparison of Two Triple Regimens for Treatment and Retreatment of Chronic Hepatitis C Infection
Official title: Comparison of Two Triple Regimens for Treatment and Retreatment of Chronic Hepatitis C Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C Infection
Keywords: Hepatitis C infection
Hepatitis C Virus
HCV
Lead sponsor: Southern Illinois University
Sponsor class: OTHER
First posted: 2013-01-18
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility 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

Primary outcomes:
measure: Virologic Response
timeFrame: up to 96 weeks post treatment
Secondary outcomes:
measure: Adverse events
timeFrame: 24, 48, and 96 weeks post treatment
measure: Effect of baseline variables on treatment outcome
timeFrame: 24, 48, and 96 weeks post treatment
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
Study officials:
affiliation: Southern Illinois University School of Medicine
name: Janak Koirala, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Koirala J, Gandotra SD, Rao S, Sangwan G, Mushtaq A, Htwe TH, Adamski A, Blessman D, Khardori NM. Granulocyte colony-stimulating factor dosing in pegylated interferon alpha-induced neutropenia and its impact on outcome of anti-HCV therapy. J Viral Hepat. 2007 Nov;14(11):782-7. doi: 10.1111/j.1365-2893.2007.00870.x.
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