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Antiviral

Sofosbuvir/Velpatasvir for Chronic Hepatitis C

Phase 4
Waitlist Available
Led By Elizabeth E Krans, MD, MSc
Research Sponsored by Elizabeth Krans, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 months post-treatment, up to 18 months
Awards & highlights

Study Summary

This trial will help determine whether a combined, peripartum HCV and opioid maintenance treatment program is feasible and acceptable to women with OUD and whether this approach is associated with improved HCV treatment uptake and health outcomes.

Eligible Conditions
  • Chronic Hepatitis C
  • Opioid Use Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 months post-treatment, up to 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 months post-treatment, up to 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Initiating in Hepatitis C Virus (HCV) Treatment
Secondary outcome measures
HCV Reinfection
Health-related Quality of Life
Intravenous Drug Use Recidivism
+3 more

Side effects data

From 2022 Phase 4 trial • 32 Patients • NCT03057847
38%
Headaches
22%
Fatigue
9%
Nausea
6%
Insomnia
6%
Weakness
3%
Blood in Stool
3%
Teeth sensitivity
3%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
SOF/VEL

Trial Design

1Treatment groups
Experimental Treatment
Group I: SOF/VELExperimental Treatment1 Intervention
Sofosbuvir/Velpatasvir, One tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily for 12 weeks in the postpartum period
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sofosbuvir
FDA approved

Find a Location

Who is running the clinical trial?

Elizabeth Krans, MDLead Sponsor
1 Previous Clinical Trials
100 Total Patients Enrolled
Elizabeth E Krans, MD, MScPrincipal InvestigatorUniversity of Pittsburgh
2 Previous Clinical Trials
255 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Sofosbuvir/Velpatasvir in Postpartum Women With Opioid Use Disorder and Chronic Hepatitis C Infection
Elizabeth Krans, MD 2018. "Sofosbuvir/Velpatasvir in Postpartum Women With Opioid Use Disorder and Chronic Hepatitis C Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03057847.
~4 spots leftby Apr 2025
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