Hepatitis C Virus Post-Exposure Prophylaxis for Health Care Workers
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|ClinicalTrials.gov Identifier: NCT01766115|
Recruitment Status : Withdrawn
First Posted : January 11, 2013
Last Update Posted : August 13, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Viral Hepatitis C||Drug: Telaprevir||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hepatitis C Virus Post-Exposure Prophylaxis for Health Care Workers|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
750 mg oral tablet of telaprevir will be given three times per day for 4 weeks within a five (5) day period from health care worker exposure.
HCV Protease Inhibitor
Other Name: Incivek
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: One year ]We seek to monitor the safety and tolerability of telaprevir, specifically with respect to the reported adverse effects of rash, pruritus, nausea, diarrhea, vomiting, anal or rectal discomfort (including hemorrhoids), dysgeusia, and fatigue. Furthermore, we will assess the incidence of anemia in the study population at weeks 1, 2, and 4.
- Election rate of study drug [ Time Frame: One year ]During the study period, we will measure the proportion of health care workers who elect to take telaprevir for HCV post-exposure prophylaxis among the total number of HCW eligible to receive the study drug. We will also record the reasons why eligible HCW declined to participate in the study, if disclosed to the study staff.
- Rate of HCV infection [ Time Frame: One year ]Although this trial is not designed nor powered to study the efficacy of telaprevir for post-exposure prophylaxis, it will be important to measure the breakthrough rate of HCV in patients who elected treatment for 4 weeks and to calculate the rate of HCV among those who elect to not take telaprevir. The trial will be performed according to an intention-to-treat analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01766115
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Raymond T. Chung, MD||Massachusetts General Hospital|