Hepatitis C Virus Post-Exposure Prophylaxis for Health Care Workers
This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
Raymond T. Chung, MD, Massachusetts General Hospital
First received: January 7, 2013
Last updated: August 12, 2014
Last verified: August 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.
Viral Hepatitis C
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
||Hepatitis C Virus Post-Exposure Prophylaxis for Health Care Workers
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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:
| Study Completion Date:
| Primary Completion Date:
||May 2014 (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
|Ages Eligible for Study:
||18 Years to 70 Years (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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 for study inclusion. Women whom are not pregnant and elect to enroll in the study will be advised that hormonal contraceptives may not be reliable during the study period and for up to two weeks following cessation of the study drug. During this time, female patients of childbearing potential should use two non-hormonal methods of effective birth control, examples of which include a male condom with spermicidal jelly OR female condom with spermicidal jelly (a combination of a male condom and a female condom is not suitable), a diaphragm with spermicidal jelly, a cervical cap with spermicidal jelly, or an intrauterine device (IUD).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01766115
|Massachusetts General Hospital
|Boston, Massachusetts, United States, 02114 |
Massachusetts General Hospital
||Raymond T. Chung, MD
||Massachusetts General Hospital
||Raymond T. Chung, MD, Director of Hepatology, Massachusetts General Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 7, 2013
||August 12, 2014
||United States: Food and Drug Administration
Keywords provided by Massachusetts General Hospital:
health care worker
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 06, 2016
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections