Respiratory FailurePhase 4NCT03625687

Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Lung Transplant

A Phase 4 study testing Clinically prescribed direct acting antiviral (Mavyret or Epclusa) HCV treatment for 8 weeks in people with Respiratory Failure and Hepatitis C, run by Massachusetts General Hospital at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

This is a proof of concept, single center study for the donation of HCV-positive lungs to HCV negative recipient patients, with preemptive, interventional treatment with 8 weeks of commercially available DAA therapy to prevent HCV transmission upon transplantation. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Respiratory Failure, Hepatitis C
What is being tested?: Clinically prescribed direct acting antiviral (Mavyret or Epclusa) HCV treatment for 8 weeks
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteUnited States
Study dates: 5 Feb 2019to 4 Apr 2022
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Met MGH transplant center criteria, listed for lung transplant
Able to sign informed consent

Who cannot join

Pregnant or nursing (lactating) women
HIV positivity
Any contra-indication to lung transplantation per center protocol
For study patients in whom Epclusa® therapy is being considered, exclusion criteria includes patients on the following p-glycoprotein inducers or moderate to potent CYP inducers that cannot stop therapy: carbamazepine, phenytoin, phenobarbital, oxcarbazepine, rifabutin, rifampin, rifapentine, St. John's wort.
For study patients in whom MavyretTM therapy is being considered, exclusion criteria includes patients on the following medications who cannot stop therapy: carbamazepine, rifampin, St. John's wort, and ethinyl estradiol-containing oral contraceptives.

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

Read the detailed description

The goal of this study is to determine if preoperative dosing and sustained administration of pan-genotypic DAA therapy after lungs transplantation prevents the transmission of hepatitis C virus (HCV) infection from an HCVpositive donor lung to an HCV naïve recipient.

Conditions: Respiratory Failure, Hepatitis C
Being tested: Clinically prescribed direct acting antiviral (Mavyret or Epclusa) HCV treatment for 8 weeks
Keywords: Lung disease, Lung Transplant, HCV, Hepatitis C
Medical subject headings: Respiratory Insufficiency, Hepatitis C, Lung Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Clinically prescribed direct acting antiviral (Mavyret or Epclusa) HCV treatment for 8 weeksDrug
Also called DAA treatment, Mavyret, Epclusa
8 weeks of direct acting antiviral treatment based on clinical indication (either Mavyret or Epclusa)

Study groups in NCT03625687
Study group	Role	What they receive
Treatment with Direct Acting Antiviral for HCV	Experimental	8 weeks of treatment with HCV Direct Acting Antiviral tablet (Mavyret or Epclusa) Receives: Drug: Clinically prescribed direct acting antiviral (Mavyret or Epclusa) HCV treatment for 8 weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

Undetectable Blood HCV RNA Level
Negative HCV RNA by blood testing at 12 weeks after the last dose of treatment.
Measured: 12 weeks post last dose of treatment with DAA

Secondary outcomes (2)

Number of Participants With Treatment Emergent Adverse Events
Safety and tolerability of DAA therapy in the lung transplant recipient monitored by quantifying the number of treatment related adverese events per patient and evaluation clinically significant out of range lab results as compared to baseline/pretreatment values per patient
Measured: 8 weeks
Tolerability (Based on Number of Adverse Events and Clinically Significant Laboratory Values)
Tolerability of commercially available DAA therapy in the lung transplant patient will be monitored by quantifying the number of treatment related adverse events per patient and evaluating clinically significant laboratory results
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Feb 20194 Apr 2022

First posted10 Aug 2018
Study start5 Feb 2019
Primary completion4 Apr 2022
Study completion4 Apr 2022

Why it stopped: Lack of funding, transitioned to standard of care

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Respiratory FailureStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03625687
Sponsor's protocol ID: 2018P001697
Status last verified: Apr 2023
First submitted: 30 Jul 2018
Last updated: 25 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Anticipate to share coded data with collaborators

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Regional Lung Ventilation During Prone Position in in Intubated Children
Pediatric Acute Respiratory Failure
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Not yet recruiting
Mechanical Ventilator Adjustments and Patient Dyspnea
Respiratory Failure, Dyspnea During Mechanical Ventilation
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome

All Respiratory Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Lung Transplant
ClinicalTrials.gov ID: NCT03625687
Acronym / sponsor ID: 2018P001697
Conditions: Respiratory Failure, Hepatitis C
Keywords: Lung disease, Lung Transplant, HCV, Hepatitis C
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Lack of funding, transitioned to standard of care
Enrolment: 19 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Study start: 5 Feb 2019 (actual)
Primary completion: 4 Apr 2022 (actual)
Study completion: 4 Apr 2022 (actual)
First posted: 10 Aug 2018 (actual)
Results: Posted 25 Apr 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment with Direct Acting Antiviral for HCV	Experimental	Drug: Clinically prescribed direct acting antiviral (Mavyret or Epclusa) HCV treatment for 8 weeks8 weeks of treatment with HCV Direct Acting Antiviral tablet (Mavyret or Epclusa)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Met MGH transplant center criteria, listed for lung transplant
Able to sign informed consent

Key exclusion criteria (5 listed)

Pregnant or nursing (lactating) women
HIV positivity
Any contra-indication to lung transplantation per center protocol
For study patients in whom Epclusa® therapy is being considered, exclusion criteria includes patients on the following p-glycoprotein inducers or moderate to potent CYP inducers that cannot stop therapy: carbamazepine, phenytoin, phenobarbital, oxcarbazepine, rifabutin, rifampin, rifapentine, St. John's wort.
For study patients in whom MavyretTM therapy is being considered, exclusion criteria includes patients on the following medications who cannot stop therapy: carbamazepine, rifampin, St. John's wort, and ethinyl estradiol-containing oral contraceptives.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Clinically prescribed direct acting antiviral (Mavyret or Epclusa) HCV treatment for 8 weeksAlso: DAA treatment, Mavyret, Epclusa8 weeks of direct acting antiviral treatment based on clinical indication (either Mavyret or Epclusa)	Drug	Treatment with Direct Acting Antiviral for HCV

Primary outcome

Undetectable Blood HCV RNA Level
Time frame: 12 weeks post last dose of treatment with DAA
Negative HCV RNA by blood testing at 12 weeks after the last dose of treatment.

2 secondary outcomes

Number of Participants With Treatment Emergent Adverse Events
Time frame: 8 weeks
Tolerability (Based on Number of Adverse Events and Clinically Significant Laboratory Values)
Time frame: 8 weeks

Results and safety

Results posted to the registry on 25 Apr 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment With Direct Acting Antiviral for HCV	16	15

Primary outcome: Undetectable Blood HCV RNA Level

Time frame: 12 weeks post last dose of treatment with DAA. Count of participants. Unit: Participants

Measure	Treatment With Direct Acting Antiviral for HCV n = 15
Value	15

Population analysed: Number of subjects completing full course of treatment

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time of Direct Acting Antiviral Treatment initiation through last dose of therapy (8 week treatment period). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment With Direct Acting Antiviral for HCV	0 of 16 (0%)	0 of 16 (0%)	1 of 16

Limitations and caveats (from the sponsor): Study was terminated prior to completion and prior to meeting enrollment goal primarily due to lack of resources (staffing and funding) and transition of HCV-positive to HCV-negative lung transplants to standard of care. Full planned analysis was not completed due to enrollment number, however primary endpoint was assessed for all 16 subjects receiving treatment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Anticipate to share coded data with collaborators

Related trials for Respiratory Failure

Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Regional Lung Ventilation During Prone Position in in Intubated Children
Pediatric Acute Respiratory Failure
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Not yet recruiting
Mechanical Ventilator Adjustments and Patient Dyspnea
Respiratory Failure, Dyspnea During Mechanical Ventilation
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Raymond T Chung, MD principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Undetectable Blood HCV RNA Level (time frame: 12 weeks post last dose of treatment with DAA). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03625687.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.