Hepatitis C Virus Post-Exposure Prophylaxis for Health Care Workers

NCT01766115 | Withdrawn Phase 4 DMC

• 1 other identifier: 2012P000954
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Viral Hepatitis C

Keywords

HCV; needlestick; occupational; transmission; health care worker; telaprevir

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  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.

  One year

Secondary Outcomes (2)

• Election rate of study drug

  One year

• Rate of HCV infection

  One year

Study Arms (1)

Telaprevir

EXPERIMENTAL

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

Interventions

Telaprevir DRUG

HCV Protease Inhibitor

Also known as: Incivek

Telaprevir

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Hepatitis C; Needlestick Injuries

Interventions

telaprevir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Wounds, Stab; Wounds, Penetrating; Wounds and Injuries

Study Officials

• Raymond T. Chung, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Hepatology

Study Record Dates

• First Submitted: January 7, 2013
• First Posted: January 11, 2013
• Study Start: April 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: August 13, 2014

Record last verified: 2014-08

Locations

US (1)