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HCV Post-Exposure Prophylaxis for Health Care Workers

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03313414
Collaborator
Gilead Sciences (Industry)
0
Enrollment
1
Location
1
Arm
5.1
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: Sofosbuvir/Velpatasvir Treatment for 14 days
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Hepatitis C Virus Post-Exposure Prophylaxis for Health Care Workers
Actual Study Start Date :
Aug 13, 2019
Anticipated Primary Completion Date :
Jan 1, 2020
Actual Study Completion Date :
Jan 16, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Undetectable HCV RNA [12 weeks post treatment]

      Negative HCV viral RNA at 12 weeks after the last dose of treatment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Boston Massachusetts United States 02114

    Sponsors and Collaborators

    • Massachusetts General Hospital
    • Gilead Sciences

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Raymond Chung, Director of Hepatology, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT03313414
    Other Study ID Numbers:
    • 2017P001661
    First Posted:
    Oct 18, 2017
    Last Update Posted:
    Jan 21, 2020
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Raymond Chung, Director of Hepatology, Massachusetts General Hospital
    HCV
    Needlestick
    Additional relevant MeSH terms:
    Hepatitis C
    Hepatitis
    Sofosbuvir
    Sofosbuvir-velpatasvir drug combination
    Velpatasvir

    Study Results

    No Results Posted as of Jan 21, 2020