End Stage Heart DiseasePhase 4NCT03208244

DAA Treatment in Donor HCV-positive to Recipient HCV-negative Heart Transplant

A Phase 4 study testing Clinically prescribed direct acting antiviral in people with End Stage Heart Disease 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

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Trial summary

This is a proof of concept, single center study for the donation of HCV-positive hearts to HCV negative recipient patients, with preemptive, interventional treatment with 12 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: End Stage Heart Disease, Hepatitis C
What is being tested?: Clinically prescribed direct acting antiviral
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 9 Nov 2017to 28 Apr 2021
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

Recipient is Age ≥ 18 years
Serum ALT within normal limits with no history of liver disease
Lack of sensitization (i.e. PRA < 20%) that would be expected to result in a high likelihood of needing aggressive immunosuppression to treat rejection

Who cannot join

Sensitization (i.e. PRA >20%)
Any liver disease in recipient
Albumin < 3g/dl or platelet count < 75 x 103/mL
Need for dual organ transplant

Trial locations and contacts

1 site in 1 country.

United States1 site

Masschusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Heart Transplant

Read the detailed description

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

Conditions: End Stage Heart Disease, Hepatitis C
Being tested: Clinically prescribed direct acting antiviral
Keywords: Heart Disease, Heart Transplant, HCV, Hepatitis C
Medical subject headings: Hepatitis C, Heart Diseases

What participants receive

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

Clinically prescribed direct acting antiviralDrug
Also called DAA treatment
HCV treatment for 12 weeks

Study groups in NCT03208244
Study group	Role	What they receive
Treatment with Direct Acting Antiviral for HCV	Experimental	12 weeks of treatment with HCV Direct Acting Antiviral tablet Receives: Drug: Clinically prescribed direct acting antiviral

What is being measured

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

Number of Participants With Undetectable HCV RNA at 12 Weeks Post Treatment
Negative HCV viral RNA at 12 weeks after the last dose of treatment.
Measured: 12 weeks post treatment

Secondary outcomes (1)

Number of Participants With Adverse Events and Clinically Significant Out of Range Lab Values of DAA Therapy in Patients Undergoing Cardiac Transplantation
Safety and tolerablity of commercially available DAA therapy in the cardiac transplant patient will be monitored by quantifying the number of treatment related adverse events per patient and evaluating out of range laboratory results as compared to baseline/pretreatment values per patient.
Measured: 12 weeks

Timeline

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

9 Nov 201728 Apr 2021

First posted5 Jul 2017
Study start9 Nov 2017
Primary completion20 Apr 2021
Study completion28 Apr 2021

Why it stopped: Protocol transitioned to standard of care, no funding available to support research work

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for End Stage Heart DiseaseStudies 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
Model description: Received heart transplant from HCV+ donor
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03208244
Sponsor's protocol ID: 2017P001427
Status last verified: Jun 2022
First submitted: 3 Jul 2017
Last updated: 22 Jun 2022
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

Publications

Bethea ED, Gaj K, Gustafson JL, Axtell A, Lebeis T, Schoenike M, Turvey K, Coglianese E, Thomas S, Newton-Cheh C, Ibrahim N, Carlson W, Ho JE, Shah R, Nayor M, Gift T, Shao S, Dugal A, Markmann J, Elias N, Yeh H, Andersson K, Pratt D, Bhan I, Safa K, Fishman J, Kotton C, Myoung P, Villavicencio MA, D'Alessandro D, Chung RT, Lewis GD. Pre-emptive pangenotypic direct acting antiviral therapy in donor HCV-positive to recipient HCV-negative heart transplantation: an open-label study. Lancet Gastroenterol Hepatol. 2019 Oct;4(10):771-780. doi: 10.1016/S2468-1253(19)30240-7. Epub 2019 Jul 26.
PubMed 31353243

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

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All End Stage Heart Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2022. 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 Heart Transplant
ClinicalTrials.gov ID: NCT03208244
Acronym / sponsor ID: 2017P001427
Conditions: End Stage Heart Disease, Hepatitis C
Keywords: Heart Disease, Heart Transplant, HCV, Hepatitis C
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Protocol transitioned to standard of care, no funding available to support research work
Enrolment: 40 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Study start: 9 Nov 2017 (actual)
Primary completion: 20 Apr 2021 (actual)
Study completion: 28 Apr 2021 (actual)
First posted: 5 Jul 2017 (actual)
Results: Posted 2 Jun 2022

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
Model description: Received heart transplant from HCV+ donor

Arm	Type	Receives
Treatment with Direct Acting Antiviral for HCV	Experimental	Drug: Clinically prescribed direct acting antiviral12 weeks of treatment with HCV Direct Acting Antiviral tablet

Who may qualify

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

Key inclusion criteria (3 listed)

Recipient is Age ≥ 18 years
Serum ALT within normal limits with no history of liver disease
Lack of sensitization (i.e. PRA < 20%) that would be expected to result in a high likelihood of needing aggressive immunosuppression to treat rejection

Key exclusion criteria (4 listed)

Sensitization (i.e. PRA >20%)
Any liver disease in recipient
Albumin < 3g/dl or platelet count < 75 x 103/mL
Need for dual organ transplant

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 antiviralAlso: DAA treatmentHCV treatment for 12 weeks	Drug	Treatment with Direct Acting Antiviral for HCV

Primary outcome

Number of Participants With Undetectable HCV RNA at 12 Weeks Post Treatment
Time frame: 12 weeks post treatment
Negative HCV viral RNA at 12 weeks after the last dose of treatment.

1 secondary outcome

Number of Participants With Adverse Events and Clinically Significant Out of Range Lab Values of DAA Therapy in Patients Undergoing Cardiac Transplantation
Time frame: 12 weeks

Results and safety

Results posted to the registry on 2 Jun 2022, 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	33	32

Primary outcome: Number of Participants With Undetectable HCV RNA at 12 Weeks Post Treatment

Time frame: 12 weeks post treatment. Count of participants. Unit: Participants

Measure	Treatment With Direct Acting Antiviral for HCV n = 30
Value	30

Population analysed: number of subjects active on study at 12 weeks post DAA treatment

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected during the dosing period from date of first dose through date of last dose, an average of 12 weeks.. 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 33 (0%)	0 of 33 (0%)	1 of 33

Limitations and caveats (from the sponsor): Protocol was terminated prior to completion, primarily due to lack of resources (research staffing and funding) and clinical team moving HCV+ donor to HCV- recipient transplants to standard of care.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31353243Bethea ED, Gaj K, Gustafson JL, Axtell A, Lebeis T, Schoenike M, Turvey K, Coglianese E, Thomas S, Newton-Cheh C, Ibrahim N, Carlson W, Ho JE, Shah R, Nayor M, Gift T, Shao S, Dugal A, Markmann J, Elias N, Yeh H, Andersson K, Pratt D, Bhan I, Safa K, Fishman J, Kotton C, Myoung P, Villavicencio MA, D'Alessandro D, Chung RT, Lewis GD. Pre-emptive pangenotypic direct acting antiviral therapy in donor HCV-positive to recipient HCV-negative heart transplantation: an open-label study. Lancet Gastroenterol Hepatol. 2019 Oct;4(10):771-780. doi: 10.1016/S2468-1253(19)30240-7. Epub 2019 Jul 26.
Individual participant dataSharing planned: Yes. Anticipate to share coded data with collaborators

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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 L 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?

A Phase 4 study testing Clinically prescribed direct acting antiviral in people with End Stage Heart Disease and Hepatitis C, run by Massachusetts General Hospital at 1 site in United States.

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 3 inclusion and 4 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 22 Jun 2022. 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 2 Jun 2022). 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?

Number of Participants With Undetectable HCV RNA at 12 Weeks Post Treatment (time frame: 12 weeks post treatment). 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 NCT03208244, which also lists 1 linked publication.

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 22 Jun 2022.