HCV Post-Exposure Prophylaxis for Health Care Workers

Hepatitis C Clinical Trial

Official title:

Hepatitis C Virus Post-Exposure Prophylaxis for Health Care Workers

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03313414
• Other study ID #: 2017P001661
• Status: Withdrawn
• Phase: Phase 4
• Start date: August 13, 2019
• Est. completion date: January 16, 2020

Study information

• Verified date: January 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 16, 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C

Intervention

Drug:
• Sofosbuvir/Velpatasvir Treatment for 14 days
14 day therapy with Sofosbuvir/Velpatasvir

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Undetectable HCV RNA	Negative HCV viral RNA at 12 weeks after the last dose of treatment.	12 weeks post treatment