HCV Post-Exposure Prophylaxis for Health Care Workers | NCT03313414

Studies
HCV Post-Exposure Prophylaxis for Health Care Workers

NCT03313414

Sponsor

Massachusetts General Hospital

Status

Withdrawn

Last Update Posted

Jan 21, 2020Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Hepatitis C

Interventions

Sofosbuvir/Velpatasvir Treatment for 14 days

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No participant enrollment, funding withdrawn.

Expanded Access Info

Start Date

Aug 13, 2019Actual

Primary Completion Date

Jan 2020Estimated

Completion Date

Jan 16, 2020Actual

First Submitted Date

Oct 13, 2017

First Submission Date that Met QC Criteria

Oct 13, 2017

First Posted Date

Oct 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2020

Last Update Posted Date

Jan 21, 2020Actual

Name	Class
Gilead Sciences	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment with Sofosbuvir/Velpatasvir	Experimental	14 days of treatment with Sofosbuvir/Velpatasvir tablet	Drug: Sofosbuvir/Velpatasvir Treatment for 14 days

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sofosbuvir/Velpatasvir Treatment for 14 days	Drug	14 day therapy with Sofosbuvir/Velpatasvir	Treatment with Sofosbuvir/Velpatasvir

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Undetectable HCV RNA	Negative HCV viral RNA at 12 weeks after the last dose of treatment.	12 weeks post treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Raymond Chung, MD	Massachusetts General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02114	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

no plan currently to share IPD with other researchers

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006526	Hepatitis C
D016602	Needlestick Injuries

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069474	Sofosbuvir
C000611331	sofosbuvir-velpatasvir drug combination

Ancestor Terms

ID	Term
D014542	Uridine Monophosphate
D014500	Uracil Nucleotides
D011742	Pyrimidine Nucleotides
D011743	Pyrimidines

Browse Leaves

Not provided

Browse Branches

Not provided