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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 belowTimeline
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)
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.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: PWID (people who inject drugs)
- Group 2: Non-PWID
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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