Hepatitis C Virus Post-Exposure Prophylaxis for Health Care Workers
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Hepatitis C Virus Post-Exposure Prophylaxis for Health Care Workers|
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: One year ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
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
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01766115
|Contact: Raymond T. Chung, MD||617 724 firstname.lastname@example.org|
|Contact: Jennifer Chen, MD||617 726 2241||JYCHEN@PARTNERS.ORG|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Raymond T. Chung, MD 617-724-6006 email@example.com|
|Contact: Jennifer Y. Chen, MD firstname.lastname@example.org|
|Principal Investigator: Raymond T. Chung, MD|
|Sub-Investigator: Jennifer Y. Chen, MD|
|Sub-Investigator: Anna Rutherford, MD|
|Sub-Investigator: Elisha Atkins, MD|
|Sub-Investigator: Karin Andersson, MD|
|Sub-Investigator: Kathleen Corey, MD|
|Sub-Investigator: Andrew Gottlieb, MD|
|Sub-Investigator: Dean Hashimoto, MD|
|Sub-Investigator: Arthur Kim, MD|
|Sub-Investigator: Daniel Pratt, MD|
|Sub-Investigator: Gregory Robbins, MD|
|Principal Investigator:||Raymond T. Chung, MD||Massachusetts General Hospital|