Purpose

This is an unblinded, observational trial of sofosbuvir-velpatasvir in adult health care workers who are exposed to hepatitis C virus from needlestick injury with hollow-bore needles.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Healthcare worker with exposure through needlestick injury with hollow-bore needles to source patients who are HCV positive - Healthcare worker must be HCV Ab-

Exclusion Criteria

  • HCV Ab positive - HCV Ab negative and HCV RNA greater than 1000 IU/ml - Active malignancy - Positive urine pregnancy test

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment with Sofosbuvir/Velpatasvir
14 days of treatment with Sofosbuvir/Velpatasvir tablet
  • Drug: Sofosbuvir/Velpatasvir Treatment for 14 days
    14 day therapy with Sofosbuvir/Velpatasvir
    Other names:
    • Epclusa

More Details

Status
Withdrawn
Sponsor
Massachusetts General Hospital

Study Contact

Detailed Description

The goal of this study is to assess the safety and tolerability of the use of sofosbuvir-velpatasvir in the setting of post-exposure prophylaxis among Health Care Workers exposed to HCV from needlestick injury with hollow-bore needles

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.