End Stage Liver DiseasePhase 4NCT03208127

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

A Phase 4 study testing Treatment with Direct Acting Antiviral tablet in people with End Stage Liver 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 single center study for the donation of Hepatitis C Virus (HCV)-positive livers to HCV negative recipient patients, with preemptive, interventional treatment 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 Liver Disease, Hepatitis C
What is being tested?: Treatment with Direct Acting Antiviral tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 1 siteUnited States
Study dates: 21 Nov 2017to 4 Jun 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
Met Massachusetts General Hospital (MGH) transplant center criteria, listed for liver transplant
HCV naïve
Able to sign informed consent

Who cannot join

Pregnant or nursing (lactating) women
Human immunodeficiency virus (HIV) positivity
Need for dual organ transplant
Any contra-indication to liver transplantation per center protocol

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 Liver Transplant

Read the detailed description

Patients will be selected based on diminished likelihood of receiving a liver from the waitlist within a period during which they would be likely to succumb to severe comorbidities. This will be determined in part through use of a patient's Model of End Stage Liver Disease (MELD) score, listing status, and clinical judgment. To ensure maximal benefit for the recipient, only high quality donor livers will be accepted.

Conditions: End Stage Liver Disease, Hepatitis C
Being tested: Treatment with Direct Acting Antiviral tablet
Keywords: HCV, Epclusa, ESLD
Medical subject headings: End Stage Liver Disease, Hepatitis C

What participants receive

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

Treatment with Direct Acting Antiviral tabletDrug
Also called DAA
HCV Treatment for 12 Weeks

Study groups in NCT03208127
Study group	Role	What they receive
Treatment with Direct Acting Antiviral (DAA) Fixed Dose Combination	Experimental	12 weeks of HCV treatment with medically appropriate direct acting antiviral Receives: Drug: Treatment with Direct Acting Antiviral tablet

What is being measured

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

Number of Participants With Undetectable Hepatitis C Virus (HCV) Viral RNA
Number of dosed subjects with 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 Treatment Emergent Adverse Events and Out of Range Lab Values
Safety and tolerability of direct acting antiviral therapy in the liver transplant patient will be monitored by quantifying the number of treatment related adverse events per patient and evaluating clinically significant 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.

21 Nov 20174 Jun 2021

First posted5 Jul 2017
Study start21 Nov 2017
Primary completion4 Jun 2021
Study completion4 Jun 2021

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

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 End Stage Liver 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
Masking: None (open label)
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03208127
Sponsor's protocol ID: 2017P000653
Status last verified: Jul 2022
First submitted: 3 Jul 2017
Last updated: 28 Jul 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Coded data is anticipated to be shared with potential 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

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All End Stage Liver Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 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 Liver Transplant
ClinicalTrials.gov ID: NCT03208127
Acronym / sponsor ID: 2017P000653
Conditions: End Stage Liver Disease, Hepatitis C
Keywords: HCV, Epclusa, ESLD
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Protocol transitioned to standard of care, no funding available to continue support of research work or data analysis
Enrolment: 33 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Study start: 21 Nov 2017 (actual)
Primary completion: 4 Jun 2021 (actual)
Study completion: 4 Jun 2021 (actual)
First posted: 5 Jul 2017 (actual)
Results: Posted 28 Jul 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

Arm	Type	Receives
Treatment with Direct Acting Antiviral (DAA) Fixed Dose Combination	Experimental	Drug: Treatment with Direct Acting Antiviral tablet12 weeks of HCV treatment with medically appropriate direct acting antiviral

Who may qualify

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

Key inclusion criteria (4 listed)

Recipient is Age ≥ 18 years
Met Massachusetts General Hospital (MGH) transplant center criteria, listed for liver transplant
HCV naïve
Able to sign informed consent

Key exclusion criteria (4 listed)

Pregnant or nursing (lactating) women
Human immunodeficiency virus (HIV) positivity
Need for dual organ transplant
Any contra-indication to liver transplantation per center protocol

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
Treatment with Direct Acting Antiviral tabletAlso: DAAHCV Treatment for 12 Weeks	Drug	Treatment with Direct Acting Antiviral (DAA) Fixed Dose Combination

Primary outcome

Number of Participants With Undetectable Hepatitis C Virus (HCV) Viral RNA
Time frame: 12 weeks post treatment
Number of dosed subjects with negative HCV viral RNA at 12 weeks after the last dose of treatment.

1 secondary outcome

Number of Participants With Treatment Emergent Adverse Events and Out of Range Lab Values
Time frame: 12 weeks

Results and safety

Results posted to the registry on 28 Jul 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 Fixed Dose Combination	24	23

Primary outcome: Number of Participants With Undetectable Hepatitis C Virus (HCV) Viral RNA

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

Measure	Treatment With Direct Acting Antiviral Fixed Dose Combination n = 23
Value	23

Population analysed: 1 subject died and was not included in analysis

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collect from time of Direct Acting Antiviral Treatment initiation through last dose of therapy, 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 Fixed Dose Combination	0 of 24 (0%)	0 of 24 (0%)	2 of 24

Limitations and caveats (from the sponsor): Protocol transitioned out of research to standard of care and was closed prior to completion and planned enrollment goal was not met. Review of data from enrolled patient was used for reporting purposes and data is primarily descriptive and not based on statistical analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Coded data is anticipated to be shared with potential collaborators.

Related trials for End Stage Liver Disease

Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruiting
LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Liver Disease Chronic, End Stage Liver DIsease
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress 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 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 Treatment with Direct Acting Antiviral tablet in people with End Stage Liver 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 4 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 28 Jul 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 28 Jul 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 Hepatitis C Virus (HCV) Viral RNA (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 NCT03208127.

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 28 Jul 2022.