HCV Post-Exposure Prophylaxis for Health Care Workers

Phase 4

Withdrawn

• Conditions: Hepatitis C
• Interventions: Drug: Sofosbuvir/Velpatasvir Treatment for 14 days

• Registration Number: NCT03313414
• Lead Sponsor: Massachusetts General Hospital

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.

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 Timeline

• Study First Submitted: 2017-10-13
• Study First Submitted QC: 2017-10-13
• Study First Posted: 2017-10-18
• Study Start: 2019-08-13
• Status Verified: 2020-01
• Primary Completion: 2020-01
• Study Completion: 2020-01-16
• Last Update Submitted: 2020-01-16
• Last Update Posted: 2020-01-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment with Sofosbuvir/Velpatasvir	Sofosbuvir/Velpatasvir Treatment for 14 days	14 days of treatment with Sofosbuvir/Velpatasvir tablet

Primary Outcome Measures

Name	Time	Method
Undetectable HCV RNA	12 weeks post treatment	Negative HCV viral RNA at 12 weeks after the last dose of treatment.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States