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Antiviral

Velpatasvir + Sofosbuvir for Hepatitis C

Phase 4

Waitlist Available

Led By brian pearlman, MD

Research Sponsored by Center For Hepatitis C, Atlanta, GA

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Chronic HCV infection and PWID arm: use of intravenous drug use at least once in preceding six months. In Non-PWID arm: no use of intravenous drug use at least once in preceding six months.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up in follow-up period (expected 2-3 years)

Awards & highlights

Study Summary

This trial examines how effective direct antiviral therapy is in treating hepatitis C in IV drug users compared to non-IV drug users.

Who is the study for?

This trial is for chronic hepatitis C patients who have used intravenous drugs in the past 6 months and those who haven't. Participants must be attending liver clinics where the study takes place.Check my eligibility

What is being tested?

The study tests velpatasvir and sofosbuvir, standard antiviral treatments, over a period of 12 weeks. It compares recently injecting drug users with non-users on treatment outcomes like cure rates and reinfection.See study design

What are the potential side effects?

Velpatasvir and sofosbuvir may cause headaches, fatigue, nausea, insomnia, low blood count (anemia), weakness (asthenia), and sometimes rash or irritability.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ in follow-up period (expected 2-3 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~in follow-up period (expected 2-3 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and in follow-up period (expected 2-3 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Sustained Virologic Response

Secondary outcome measures

Intravenous drug use

Opioid Substitution Therapy (OST)

Reinfection rate hepatitis C

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PWID (people who inject drugs)Experimental Treatment1 Intervention

velpatasvir (100 mg) and sofosbuvir (400 mg) once daily for 12 weeks (brand or branded generic) in subjects who had used intravenous drugs at least once in preceding six months.

Group II: Non-PWIDActive Control1 Intervention

velpatasvir (100 mg) and sofosbuvir (400 mg) once daily for 12 weeks (brand or branded generic) in subjects who had NOT used intravenous drugs at least once in preceding six months, but were treated concurrently in the same hepatology referral clinics.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Center For Hepatitis C, Atlanta, GALead Sponsor

1 Previous Clinical Trials

93 Total Patients Enrolled

brian pearlman, MDPrincipal InvestigatorWellstar Internal Medicine Associates

Media Library

Velpatasvir and Sofosbuvir (Antiviral) Clinical Trial Eligibility Overview. Trial Name: NCT05895448 — Phase 4

People Who Inject Drugs Research Study Groups: PWID (people who inject drugs), Non-PWID

People Who Inject Drugs Clinical Trial 2023: Velpatasvir and Sofosbuvir Highlights & Side Effects. Trial Name: NCT05895448 — Phase 4

Velpatasvir and Sofosbuvir (Antiviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05895448 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the study protocol permit participants who are under 20 years old?

"The requirements for participation in this medical trial stipulate that the minimum age is 18 and any potential patients must not exceed the age of 75."

Answered by AI

May I take part in this medical research?

"Patients that meet the criteria of this clinical trial can qualify for admission if they have chronic hepatitis c and are between 18 to 75 years old. Approximately 125 individuals will be accepted in total."

Answered by AI

How deleterious is intravenous drug use for the health of individuals?

"With PWID (people who inject drugs) clinical trials in Phase 4, the safety of this intervention is established and it receives a score of 3."

Answered by AI

Is it possible to sign up for this medical experiment currently?

"Information found on clinicaltrials.gov indicates that this medicinal trial, first posted in March 2018 and last updated May 2023, is no longer accepting patients. Nevertheless, there are presently 99 other studies enrolling participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2018. "Treatment of HCV-Infected Recent Injection Drug Users in U.S. Liver Clinics". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05895448.