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Hepatitis C Virus Post-Exposure Prophylaxis for Health Care Workers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01766115
Recruitment Status : Withdrawn
First Posted : January 11, 2013
Last Update Posted : August 13, 2014
Information provided by (Responsible Party):
Raymond T. Chung, MD, Massachusetts General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Viral Hepatitis C Drug: Telaprevir Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Telaprevir
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.
Drug: Telaprevir
HCV Protease Inhibitor
Other Name: Incivek

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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).

Information from the National Library of Medicine

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 identifier (NCT number): NCT01766115

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
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Principal Investigator: Raymond T. Chung, MD Massachusetts General Hospital

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Responsible Party: Raymond T. Chung, MD, Director of Hepatology, Massachusetts General Hospital Identifier: NCT01766115    
Other Study ID Numbers: 2012P000954
First Posted: January 11, 2013    Key Record Dates
Last Update Posted: August 13, 2014
Last Verified: August 2014
Keywords provided by Raymond T. Chung, MD, Massachusetts General Hospital:
health care worker
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections