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HCV Post-Exposure Prophylaxis for Health Care Workers

Primary Purpose

Hepatitis C

Status

Withdrawn

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Sofosbuvir/Velpatasvir Treatment for 14 days

About this trial

This is an interventional prevention trial for Hepatitis C focused on measuring HCV, Needlestick

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment with Sofosbuvir/Velpatasvir

Arm Description

14 days of treatment with Sofosbuvir/Velpatasvir tablet

Outcomes

Primary Outcome Measures

Undetectable HCV RNA

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03313414

First Posted

October 13, 2017

Last Updated

January 16, 2020

Sponsor

Massachusetts General Hospital

Collaborators

Gilead Sciences

1. Study Identification

Unique Protocol Identification Number

NCT03313414

Brief Title

HCV Post-Exposure Prophylaxis for Health Care Workers

Official Title

Hepatitis C Virus Post-Exposure Prophylaxis for Health Care Workers

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Withdrawn

Why Stopped

No participant enrollment, funding withdrawn.

Study Start Date

August 13, 2019 (Actual)

Primary Completion Date

January 2020 (Anticipated)

Study Completion Date

January 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C

Keywords

HCV, Needlestick

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment with Sofosbuvir/Velpatasvir

Arm Type

Experimental

Arm Description

14 days of treatment with Sofosbuvir/Velpatasvir tablet

Intervention Type

Drug

Intervention Name(s)

Sofosbuvir/Velpatasvir Treatment for 14 days

Other Intervention Name(s)

Epclusa

Intervention Description

14 day therapy with Sofosbuvir/Velpatasvir

Primary Outcome Measure Information:

Title

Undetectable HCV RNA

Description

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

Time Frame

12 weeks post treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Raymond Chung, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

no plan currently to share IPD with other researchers

Learn more about this trial

HCV Post-Exposure Prophylaxis for Health Care Workers

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