Hepatitis C, ChronicPhase 4NCT03207399

Lung Transplantation in Chronic HCV Infection With Post Transplant EPCLUSA Treatment

A Phase 4 study testing Epclusa in people with Hepatitis C, Chronic and Lung Transplant, run by Duke University 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

The purpose of this study is to evaluate whether treatment with Epclusa (sofosbuvir/velpatasvir) after lung transplantation in individuals with chronic hepatitis C infection is feasible, safe and effective at curing HCV. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis C, Chronic, Lung Transplant
What is being tested?: Epclusa
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1 participants
Where: 1 siteUnited States
Study dates: 15 Sep 2017to 25 Mar 2019
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

HCV RNA >= 10^3 IU/ml at screening
Chronic HCV infection, defined as positive HCV antibody and/or HCV RNA more than 6 months prior to screening
HCV Genotype 1, 2, 3, 4, 5 or 6
Otherwise eligible for lung transplant at study site

Who cannot join

Age <18
Treatment with any of the following agents:
Amiodarone. Subjects previously treated with amiodarone must have stopped the amiodarone at least 60 days prior to day 1 SOF/VEL
Carbamazepine, phenytoin, phenobarbital, oxcarbazepine
Rifabutin, rifampin or rifapentine
HIV regimens containing tenofovir or tipranavir/ritonavir

Show all 21Show fewer

St John's wort
PPIs, including: Omeprazole, pantoprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole
Modafinil
Have any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with subject treatment, assessment or compliance
Hepatitis B surface antigen positive
History of hepatic encephalopathy or variceal hemorrhage
Abnormal hematological and biochemical parameters, including:
Hemoglobin <8g/dL
Platelets <= 50,000/mm^3
ALT (alanine aminotransferase), AST (aspartase aminotransferase) or alkaline phosphatase >=10 times ULN
Total bilirubin >3mg/dL
Severe renal impairment, ie creatinine clearance (CrCl) <30mL/min
Pregnant women or women planning to become pregnant
Women or are breastfeeding
Active or recent history (<=1 year) of drug or alcohol abuse

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke University Medical Center
Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: Lung Transplantation in Chronic HCV Infection With Post Transplant EPCLUSA Treatment: A Pilot Feasibility and Efficacy Study

Conditions: Hepatitis C, Chronic, Lung Transplant
Being tested: Epclusa
Medical subject headings: Hepatitis C, Chronic

What participants receive

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

EpclusaDrug
Patients will be treated with this drug for 12 weeks post lung transplant.

Study groups in NCT03207399
Study group	Role	What they receive
Epclusa	Other	Epclusa (sofosbuvir 400mg/velpatasvir 100mg) 1 tablet oral or via tube daily for 12 weeks, taken with or without food. Receives: Drug: Epclusa

What is being measured

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

Number of Participants With Sustained Virologic Response 12 Weeks (SVR 12) in Those Treated With EPCLUSA.
Sustained Virologic Response 12 weeks (SVR 12) in those treated with EPCLUSA.
Measured: 12 weeks
Number of Patients That Reported an Adverse Event Resulting in Discontinuation of EPCLUSA
Adverse events resulting in discontinuation of EPCLUSA
Measured: 1 year
Number of Patients Eligible for EPCLUSA Treatment
Eligibility for EPCLUSA treatment within 12 months of lung transplant
Measured: within 12 months of lung transplant

Secondary outcomes (6)

Change in Serum HCV RNA Levels
Serum HCV RNA levels at 12-, 24-, and 48-weeks after initiation of EPCLUSA
Measured: 12, 24, and 48 weeks after initiation of EPCLUSA
Number of Participants With Adverse Events Requiring Temporary Interruption of EPCLUSA Therapy
Adverse events requiring temporary interruption in EPCLUSA therapy
Measured: 1 year
Patient Survival
90-day post transplant patient survival
Measured: 90 days post-transplant
Patient Survival
1 year post transplant patient survival
Measured: 1 year post-tranplant
Patient Survival
90-day post transplant patient survival in recipients of HCV NAT positive donor organ
Measured: 90 days post-transplant
Patient Survival
1 year post transplant patient survival in recipients of HCV NAT positive donor organ
Measured: 1 year post-transplant

Timeline

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

15 Sep 201725 Mar 2019

First posted2 Jul 2017
Study start15 Sep 2017
Primary completion25 Mar 2019
Study completion25 Mar 2019

Why it stopped: Enrollment terminated due to not having any other eligible participants.

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 Hepatitis C, ChronicStudies of the same condition, open and under way.
More trials run by Duke UniversityThe 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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03207399
Sponsor's protocol ID: Pro00074361
Status last verified: Aug 2019
First submitted: 30 Jun 2017
Last updated: 11 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

All Hepatitis C, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Lung Transplantation in Chronic HCV Infection With Post Transplant EPCLUSA Treatment: A Pilot Feasibility and Efficacy Study
ClinicalTrials.gov ID: NCT03207399
Acronym / sponsor ID: Pro00074361
Conditions: Hepatitis C, Chronic, Lung Transplant
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Enrollment terminated due to not having any other eligible participants.
Enrolment: 1 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Study start: 15 Sep 2017 (actual)
Primary completion: 25 Mar 2019 (actual)
Study completion: 25 Mar 2019 (actual)
First posted: 2 Jul 2017 (actual)
Results: Posted 11 Sep 2019

Clinical summary

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

Study design

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

Arm	Type	Receives
Epclusa	Other	Drug: EpclusaEpclusa (sofosbuvir 400mg/velpatasvir 100mg) 1 tablet oral or via tube daily for 12 weeks, taken with or without food.

Who may qualify

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

Key inclusion criteria (4 listed)

HCV RNA >= 10^3 IU/ml at screening
Chronic HCV infection, defined as positive HCV antibody and/or HCV RNA more than 6 months prior to screening
HCV Genotype 1, 2, 3, 4, 5 or 6
Otherwise eligible for lung transplant at study site

Key exclusion criteria (21 listed)

Age <18
Treatment with any of the following agents:
Have any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with subject treatment, assessment or compliance
Hepatitis B surface antigen positive
History of hepatic encephalopathy or variceal hemorrhage

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
EpclusaPatients will be treated with this drug for 12 weeks post lung transplant.	Drug	Epclusa

Primary outcome

Number of Participants With Sustained Virologic Response 12 Weeks (SVR 12) in Those Treated With EPCLUSA.
Time frame: 12 weeks
Sustained Virologic Response 12 weeks (SVR 12) in those treated with EPCLUSA.
Number of Patients That Reported an Adverse Event Resulting in Discontinuation of EPCLUSA
Time frame: 1 year
Adverse events resulting in discontinuation of EPCLUSA
Number of Patients Eligible for EPCLUSA Treatment
Time frame: within 12 months of lung transplant
Eligibility for EPCLUSA treatment within 12 months of lung transplant

6 secondary outcomes

Change in Serum HCV RNA Levels
Time frame: 12, 24, and 48 weeks after initiation of EPCLUSA
Number of Participants With Adverse Events Requiring Temporary Interruption of EPCLUSA Therapy
Time frame: 1 year
Patient Survival
Time frame: 90 days post-transplant
Patient Survival
Time frame: 1 year post-tranplant
Patient Survival
Time frame: 90 days post-transplant
Patient Survival
Time frame: 1 year post-transplant

Results and safety

Results posted to the registry on 11 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Epclusa	1	1

Primary outcome: Number of Participants With Sustained Virologic Response 12 Weeks (SVR 12) in Those Treated With EPCLUSA.

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

Measure	Epclusa n = 1
Value	1

Primary outcome: Number of Patients That Reported an Adverse Event Resulting in Discontinuation of EPCLUSA

Time frame: 1 year. Count of participants. Unit: Participants

Measure	Epclusa n = 1
Value	0

Primary outcome: Number of Patients Eligible for EPCLUSA Treatment

Time frame: within 12 months of lung transplant. Count of participants. Unit: Participants

Measure	Epclusa n = 1
Value	1

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 11 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Epclusa	0 of 1 (0%)	0 of 1 (0%)	0 of 1

Limitations and caveats (from the sponsor): Enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Hepatitis C, Chronic

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

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.

Omar Mohamedaly, MD principal investigator

Duke Heath

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 Epclusa in people with Hepatitis C, Chronic and Lung Transplant, run by Duke University 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 21 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 11 Sep 2019. 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 11 Sep 2019). 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 Sustained Virologic Response 12 Weeks (SVR 12) in Those Treated With EPCLUSA. (time frame: 12 weeks). The study lists 3 primary outcomes in all. 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 NCT03207399.

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 11 Sep 2019.