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Epclusa for Hepatitis C

Phase 1

Waitlist Available

Led By Pablo Sanchez, MD

Research Sponsored by Pablo Sanchez

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 at 2 years

Awards & highlights

Study Summary

This trial will use HCV positive lungs for transplant on HCV negative recipients. If infection occurs in the recipient, they will be given treatment.

Eligible Conditions

Lung Transplant
Hepatitis C

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 2 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

HCV Viremia

Liver Function Testing

Seroconversion

+1 more

Secondary outcome measures

Rejection

Waitlist

Side effects data

From 2019 Phase 2 & 3 trial • 10 Patients • NCT02825212

40%

Increased fatigue

30%

nausea and abdominal pain

20%

Urinary frequency and/or dysuria

10%

Herpes Zoster

100%

80%

60%

40%

20%

Study treatment Arm

Pts With Hep C Virus Infection-Related Cryoglobulinemia

Trial Design

1Treatment groups

Experimental Treatment

Group I: Lung TransplantExperimental Treatment1 Intervention

Patients will be transplanted with HCV positive lung. Recipients whom test positive for HCV viremia for 2 consecutive tests at any point will complete 12 weeks of Epclusa (Sofosbuvir/velpatasvir).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Velpatasvir

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Pablo SanchezLead Sponsor

1 Previous Clinical Trials

40 Total Patients Enrolled

Pablo Sanchez, MDPrincipal InvestigatorAssistant Professor of Surgery/University of Pittsburgh

8 Previous Clinical Trials

83,669 Total Patients Enrolled

Frequently Asked Questions

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

What is the patient cap for this clinical trial?

"Unfortunately, the enrollment period for this trial has closed. It was initially posted on July 30th 2019 and last updated on September 8th 2022. However, if you are still looking to participate in a medical study there are 292 trials related to hepatitis c that are actively searching for participants as well as 27 studies recruiting patients with Epclusa."

Answered by AI

Are there any particular individuals who are ideal for this research?

"This clinical trial necessitates that applicants have hepatitis c, fall within the age range of 18 and 70 years old, and is presently recruiting for around 20 spots."

Answered by AI

Is it possible for volunteers to participate in this research initiative?

"Currently, this particular research trial is inactive. It was initially posted on July 30th 2019 and the last update to it occurred September 8th 2022. Alternatively, there are currently 292 trials actively searching for hepatitis c patients and 27 studies seeking enrolment from Epclusa candidates."

Answered by AI

Does this clinical experiment extend its enrollment to individuals aged thirty-five and above?

"The minimum age of consent is required for potential participants, and the upper cutoff for recruitment lies at 70 years."

Answered by AI

Has the U.S. Food and Drug Administration certified Epclusa for public use?

"Our assessment of the safety profile for Epclusa is low, with a score of 1. This reflects its current position as an experimental drug in Phase I trials, meaning that there are limited data regarding efficacy and safety outcomes."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Expanding the Pool in Lung Transplantation

Pablo Sanchez 2019. "Expanding the Pool in Lung Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03377478.