CClinicalTrials.gg
WithdrawnNCT03313414Updated Jan 21, 2020

HCV Post-Exposure Prophylaxis for Health Care Workers

A Phase 4 interventional study of Sofosbuvir/Velpatasvir Treatment for 14 days in Hepatitis C, sponsored by Massachusetts General Hospital. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-21.

Sponsored by Massachusetts General Hospital · Phase 4, Interventional, and Prevention

Why this study was withdrawn
No participant enrollment, funding withdrawn.
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Hepatitis C

Keywords

  • HCV
  • Needlestick
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • HCV Ab positive
  • HCV Ab negative and HCV RNA greater than 1000 IU/ml
  • Active malignancy
  • Positive urine pregnancy test
04

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Treatment with Sofosbuvir/Velpatasvir

    14 days of treatment with Sofosbuvir/Velpatasvir tablet

    Drug: Sofosbuvir/Velpatasvir Treatment for 14 days

Interventions

  • DrugSofosbuvir/Velpatasvir Treatment for 14 days

    14 day therapy with Sofosbuvir/Velpatasvir

    Also known as: Epclusa

05

What researchers measure

Primary outcomes

  1. Undetectable HCV RNA

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

    Time frame: 12 weeks post treatment

06

Study locations

1 site
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
07

References and documents

Individual participant data

Plan to share: No — no plan currently to share IPD with other researchers

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03313414
Lead sponsor
Massachusetts General Hospital
Collaborators
Gilead Sciences
Responsible party
Raymond Chung (Director of Hepatology, Massachusetts General Hospital) — Principal investigator
First posted
Oct 18, 2017
Start date
Aug 13, 2019
Primary completion
Jan 2020 (estimated)
Completion
Jan 16, 2020
Last update
Jan 21, 2020

Study contacts

Raymond Chung, MD
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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