Hepatitis C Virus Post-Exposure Prophylaxis for Health Care Workers (NCT01766115) | Clinical Trial Compass
WithdrawnPhase 4
Hepatitis C Virus Post-Exposure Prophylaxis for Health Care Workers
United States0Started 2013-04
Plain-language summary
To assess the safety and tolerability of the use of telaprevir in the setting of post-exposure prophylaxis among HCW exposed to HCV genotype 1 or genotype 2.
To assess the election rate of postexposure prophylaxis for HCV-related occupational exposures in HCW.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* MGH or BWH health care workers with exposure through needlestick injury with hollow-bore needles to source patients who are anti-HCV (+) and HCV RNA (+)
* HCW is anti-HCV Ab negative. HCW exposed through needlestick injury with hollow-bore needles to source patients who are anti-HCV (+) and HCV RNA (-), regardless of the RIBA result, will not be eligible for the study. In addition, efforts will be made to identify the source patient's genotype, and if the genotype is unknown, then genotype testing will be performed. If the genotype is 2 or 3, then the HCW exposed to the source patient will not be eligible for the study.
* HCW will be eligible if exposed to a source patient who has a genotype 1, or if the genotype of the source patient is unknown or unable to be ascertained
Exclusion Criteria:
* Exposure to patient with known HCV genotype 2 or 3
* HCV Ab positive
* HCV Ab negative and HCV RNA \> 1000 IU/ml
* Active malignancy
* Other condition in the opinion of the investigators or occupational health that makes telaprevir contraindicated in HCW
* Subjects with pre-existing end stage renal impairment or severe hepatic impairment (Child Pugh B or C), and anemia (starting hemoglobin 10 or less) will be excluded.
* Pregnant women will be excluded from the study. All female participants with reproductive potential will undergo a pregnancy test (specifically qualitative urine human chorionic gonadotropin), and those who test positive will not be eligible fo…
What they're measuring
1
Number of Participants with Adverse Events as a Measure of Safety and Tolerability