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Zepatier for Lung Disease (SHELTER Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by University of Pennsylvania
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 baseline to 52 weeks
Awards & highlights

SHELTER Trial Summary

This trial is testing whether it's safe to transplant lungs from donors with Hep C into patients without it, who will then be treated with direct-acting antiviral drugs.

Eligible Conditions
  • Lung Disease

SHELTER Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Major Adverse Events Attributable to HCV Therapy in Post-lung Transplant Patients Post-lung Transplant Patients
Subject Sustained Virologic Response (SVR-12) at 12-weeks Post-treatment

Side effects data

From 2018 Phase 4 trial • 10 Patients • NCT02781649
33%
Pulomonary infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Donor Genotype 2 or 3
Donor Genotype 1a no Resistance or 1b
Donor Genotype 1a With Resistance

SHELTER Trial Design

1Treatment groups
Experimental Treatment
Group I: Direct-acting antiviral treatment for HCVExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zepatier
2016
Completed Phase 4
~110
Epclusa
2016
Completed Phase 3
~30

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
1,998 Previous Clinical Trials
42,879,371 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,881 Previous Clinical Trials
5,053,679 Total Patients Enrolled
Peter Reese, MD, MSCEStudy DirectorPerelman School of Medicine at the University of Pennsylvania
5 Previous Clinical Trials
2,101 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 are the conditions that Zepatier is approved to treat by the FDA?

"Zepatier is an effective medication for treating hepatitis c genotypes 1a, 5, and 2."

Answered by AI

How many individuals have signed up to be a part of this clinical trial?

"This clinical trial is not recruiting patients at this moment in time. The listing was first posted on December 12th, 2018 and was edited most recently on June 27th, 2022. If you are seeking other studies, 599 trials for patients with lung diseases and 34 Zepatier trials are actively recruiting."

Answered by AI

Are elderly individuals welcome to enroll in this clinical test?

"According to the age requirements specified in this study, patients must be between 18-67 years old."

Answered by AI

Does this clinical trial have any open slots for new participants?

"Unfortunately, this particular trial is not accepting patients at the moment. It was originally posted on December 12th, 2018 but has not been updated since June 27th, 2022. There are, however, 633 other clinical trials that are currently seeking participants."

Answered by AI

How can I sign up to take part in this research project?

"This research is seeking 10 individuals that have a pulmonary disorder and are between 18-67 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Transplanting Hepatitis C Lungs Into Negative Lung Recipients
2018. "Transplanting Hepatitis C Lungs Into Negative Lung Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03724149.
~2 spots leftby Apr 2025
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