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HCV Post-Exposure Prophylaxis for Health Care Workers

Hepatitis C Virus Post-Exposure Prophylaxis for Health Care Workers

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03313414
Enrollment
0
Registered
2017-10-18
Start date
2019-08-13
Completion date
2020-01-16
Last updated
2020-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Keywords

HCV, Needlestick

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

Interventions

DRUGSofosbuvir/Velpatasvir Treatment for 14 days

14 day therapy with Sofosbuvir/Velpatasvir

Sponsors

Gilead Sciences
CollaboratorINDUSTRY
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Undetectable HCV RNA12 weeks post treatmentNegative HCV viral RNA at 12 weeks after the last dose of treatment.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026