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Treatment of HCV-Infected Recent Injection Drug Users in U.S. Liver Clinics

NCT05895448 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2023-06-08

No results posted yet for this study

Summary

Direct antiviral therapy (standard of care) administered to chronic hepatitis C-infected patients, in two hepatology clinics, who had used intravenous drugs in the past 6 months of signing informed consent (IC). This cohort was compared to concurrently treated chronic hepatitis C patients who were not intravenous drug users, who signed IC in these same clinics. Follow-up expected two years after cure and relapse rates recorded.

Primary end point was SVR rate and secondary end points included reinfection rates in follow-up period.

Conditions

  • Chronic Hepatitis C
  • People Who Inject Drugs

Interventions

DRUG

velpatasvir and sofosbuvir once daily for 12 weeks (brand or branded generic) .

Directly active antiviral therapy (velpatasvir 100 mg+sofobuvir 400 mg) once daily

Sponsors & Collaborators

  • Center For Hepatitis C, Atlanta, GA

    lead OTHER

Principal Investigators

  • brian pearlman, MD · Wellstar Internal Medicine Associates

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2023-11-01
Completion
2024-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT05895448 on ClinicalTrials.gov