HCV Post-Exposure Prophylaxis for Health Care Workers

NCT03313414 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 2017P001661
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C

Keywords

HCV; Needlestick

Outcome Measures

Primary Outcomes (1)

• Undetectable HCV RNA

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

  12 weeks post treatment

Study Arms (1)

Treatment with Sofosbuvir/Velpatasvir

EXPERIMENTAL

14 days of treatment with Sofosbuvir/Velpatasvir tablet

Drug: Sofosbuvir/Velpatasvir Treatment for 14 days

Interventions

Sofosbuvir/Velpatasvir Treatment for 14 days DRUG

14 day therapy with Sofosbuvir/Velpatasvir

Also known as: Epclusa

Treatment with Sofosbuvir/Velpatasvir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthcare worker with exposure through needlestick injury with hollow-bore needles to source patients who are HCV positive
• Healthcare worker must be HCV Ab-

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Gilead Sciences: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Hepatitis C; Needlestick Injuries

Interventions

Sofosbuvir; sofosbuvir-velpatasvir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Wounds, Stab; Wounds, Penetrating; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Raymond Chung, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Hepatology

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: October 18, 2017
• Study Start: August 13, 2019
• Primary Completion: January 1, 2020
• Study Completion: January 16, 2020
• Last Updated: January 21, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)