Comparative Effectiveness and Tolerability of Boceprevir vs Telaprevir

Completed · Not applicable

Conditions studied: Hepatitis C, Chronic, Cirrhosis

In brief

1. The primary objective is to study the comparative effectiveness and tolerability of boceprevir vs. telaprevir in HCV treatment, within the VA population. 2. The secondary objective: * Resource use: recording of differences in resource use, such as direct costs (e.g., drug acquisition costs) and other indirect cost (e.g., staff utilization etc.) as the study will not only derive data by comparing those two drugs but also study the effect on different treatment lengths.

Key facts

Study ID

NCT02113631

Run by

Louis Stokes VA Medical Center

People needed

50

Starts

2011-09-01

Expected to finish

2013-04-01

Last updated by the study team

2017-03-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 18 years of age
• Have HCV genotype 1 infection and evidence of chronic hepatitis, as confirmed by a liver biopsy completed within three years prior to enrollment in the study, patients with cirrhosis will not need to undergo biopsy. Patients with compensated liver cirrhosis will be eligible. Patients who have previously been treated under standard of care (Peg-IFN, Ribavrin) and were non-responders, partial responders, or relapsers will also be eligible.
• Platelet count >60,000/mm3
• Absolute neutrophil count > 1000/mm3
• Hemoglobin >11.0 g/dL for females or >12.0 g/dL for males
• Serum creatinine </=1.5 mg/dL
• Adequately controlled DM
• Normal or adequately controlled TSH on prescription medication
• All other clinical laboratory values within normal limits, unless judged not clinically significant by the investigator
• Sterile or infertile (defined as vasectomy, tubal ligation, postmenopausal, or hysterectomy), or willing to use an approved method of double-barrier contraception (hormonal plus barrier or barrier plus barrier, eg, diaphragm plus condom) from the time of first dose administration until 6 months after the last dose
• Capable of understanding instructions, adhering to study schedules and requirements, and willing to provided informed consent

You may not qualify if…

• Positive HIV or HbsAg serology
• Severe psychiatric or neuropsychiatric disorders including, but not limited to uncontrolled severe depression, history of suicidal ideations or suicide attempt(s), as determinate by SOC psychological evaluation 3 History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic (including severe retinopathy), or immune mediated disease
• Chronic hepatic diseases other than hepatitis C 5. Organ or bone marrow transplant 6. Chronic (greater than 30 days) use of immunosuppressive medications including steroids in doses equivalent to 10 mg of prednisone or higher, 30 days prior to and anytime during the course of the study 7. Female patients who are breast-feeding or have a positive pregnancy test at any time during the study 8. Males whose female partners are pregnant 9. Patients who have had a malignancy diagnosed and/or treated within the past 3 years, except for localized squamous or basal cell cancers treated by local excision 10. Patients who have participated in a clinical trial and have received an investigational drug within 30 days prior to screening 11. Current alcoholism or drug addiction

Where it is running

• Louis Stokes Cleveland VA medical center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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