HCV Post-Exposure Prophylaxis for Health Care Workers

January 16, 2020 updated by: Raymond Chung, Massachusetts General Hospital

Hepatitis C Virus Post-Exposure Prophylaxis for Health Care Workers

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Undetectable HCV RNA
Time Frame: 12 weeks post treatment
Negative HCV viral RNA at 12 weeks after the last dose of treatment.
12 weeks post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Gilead Sciences

Investigators

  • Principal Investigator: Raymond Chung, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2019

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Actual)

January 16, 2020

Study Registration Dates

First Submitted

October 13, 2017

First Submitted That Met QC Criteria

October 13, 2017

First Posted (Actual)

October 18, 2017

Study Record Updates

Last Update Posted (Actual)

January 21, 2020

Last Update Submitted That Met QC Criteria

January 16, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017P001661

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no plan currently to share IPD with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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