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A Pilot Study of Treating HCV at a Psychiatrist-staffed Outpatient Addiction Clinic

NCT03235154 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2021-05-13

Study results available
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Summary

The main purpose of this pilot study is to investigate the safety, effectiveness and tolerability of the study medication in the treatment of people with chronic hepatitis C virus infection who regularly attend a psychiatrist-staffed clinic for opiate addiction treatment.

Conditions

  • Hepatitis C, Chronic
  • Hepatitis C
  • Opiate Dependence

Interventions

DRUG

sofosbuvir/velpatasvir

12 week treatment with once daily sofosbuvir/velpatasvir fixed dose combination therapy. Tablets are formulated with 400mg sofosbuvir and 100mg velpatasvir in pink, diamond-shaped, film coated tablets.

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • Community Research Initiative of New England

    lead OTHER

Principal Investigators

  • Amy E Colson, MD MPH · Community Research Initiative of New England

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-11
Primary Completion
2019-09-26
Completion
2019-09-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03235154 on ClinicalTrials.gov