We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    Saved Studies
Previous Study | Return to List | Next Study

HCV 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.
 
ClinicalTrials.gov Identifier: NCT03313414
Recruitment Status : Withdrawn (No participant enrollment, funding withdrawn.)
First Posted : October 18, 2017
Last Update Posted : January 21, 2020
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Raymond Chung, Massachusetts General Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Hepatitis C 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : August 13, 2019
Estimated Primary Completion Date : January 2020
Actual Study Completion Date : January 16, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: Epclusa


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Undetectable HCV RNA [ Time Frame: 12 weeks post treatment ]
    Negative HCV viral RNA at 12 weeks after the last dose of treatment.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT03313414


Locations
Layout table for location information
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Gilead Sciences
Investigators
Layout table for investigator information
Principal Investigator: Raymond Chung, MD Massachusetts General Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Raymond Chung, Director of Hepatology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03313414    
Other Study ID Numbers: 2017P001661
First Posted: October 18, 2017    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no plan currently to share IPD with other researchers

Layout table for additional information
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, Massachusetts General Hospital:
HCV
Needlestick
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
RNA Virus Infections
 Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Sofosbuvir
Sofosbuvir-velpatasvir drug combination
Velpatasvir
Antiviral Agents
Anti-Infective Agents