Hepatitis CPhase 1NCT03377478
Expanding the Pool in Lung Transplantation
A Phase 1 study testing Epclusa in people with Hepatitis C and Lung Transplant, run by Pablo Sanchez at 1 site in United States.
Trial summary
To perform a study (20 patients) utilizing Hepatitis C positive (HCV Ab+/NAT -) donor lungs for hepatitis C negative recipients with post-operative surveillance and treatment only if a recipient infection occurs. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis C, Lung Transplant
- What is being tested?
- Epclusa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2019to 1 Apr 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who sign the informed consent for this study
- Patients whom agree to receive a PHS high risk organ
- Patients listed for heart transplantation
- Age 18-65
Who cannot join
- Patients who do not sign informed consent for this study
- HIV Seropositivity
- HBV Seropositivity (HBcAb and/or HBsAg positive)
- Abnormal liver enzymes - 3 times the normal liver function values (Bilirubin, INR, AST, ALT)
- Acute or chronic renal insufficiency (creatinine clearance <50 ml/min) or history of dialysis
- Patients on ECMO
Show all 11Show fewer
- Respiratory insufficiency requiring mechanical respiratory support (ventilator, BiPAP)
- Liver insufficiency
- Prior history of hepatitis C
- Allergy to Sofosbuvir/velpatasvir
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Expanding the Pool in Lung Transplantation: The Use of Hepatitis C Positive Donor Lungs in Hepatitis C Negative Recipients
To perform a study (20 patients) utilizing Hepatitis C positive (HCV Ab+/NAT -) donor lungs for hepatitis C negative recipients with post-operative surveillance and treatment only if a recipient infection occurs.
Read the detailed description
The investigators are proposing a study of efficacy, in which positive donors will be used for HCV negative patients. Following lung transplantation patients will undergo HCV antibody, virus PCR, and liver function testing. Recipients whom test positive for HCV viremia for 2 consecutive tests at any point will complete 12 weeks of Sofosbuvir/velpatasvir therapy.
This initial study would enroll 20 patients and utilize donors that are young, otherwise healthy whom are Hepatitis C antibody positive but Nucleic Acid Amplification Testing (NAT) negative (HCV Ab+/NAT-). The recipients would be limited to those patients who have previously consented to receive a high risk lung transplant, consented to participant in this study, and who are physiologically optimized for transplantation (e.g., low risk for lung transplantation).
- Conditions
- Hepatitis C, Lung Transplant
- Being tested
- Epclusa
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpclusaDrug
Also called Procedure, Sofosbuvir/velpatasvir
Patients testing positive for HCV viremia will receive 12 weeks of Epclusa.
| Study group | Role | What they receive |
|---|---|---|
| Lung Transplant | Experimental | Patients will be transplanted with HCV positive lung. Recipients whom test positive for HCV viremia for 2 consecutive tests at any point will complete 12 weeks of Epclusa (Sofosbuvir/velpatasvir). Receives: Drug: Epclusa |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCV Viremia
Incidence of HCV Viremia
Measured: at 2 years
Seroconversion
Rate of HCV seroconversion
Measured: at 2 years
Liver Function Testing
Assessment of Hepatic function
Measured: at 2 years
Survival
Survival rates
Measured: at 2 years
Secondary outcomes (2)
Rejection
The incidence of rejection
Measured: at 2 years
Waitlist
Time on waitlist will be assessed
Measured: at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start30 Jul 2019
- Primary completion21 Sep 2021
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pablo Sanchez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pablo Sanchez, University of Pittsburgh
- Investigators
- Pablo Sanchez, MD, Principal investigator, Assistant Professor of Surgery/University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377478
- Sponsor's protocol ID
- STUDY19030435
- Status last verified
- Dec 2022
- First submitted
- 14 Dec 2017
- Last updated
- 16 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding the Pool in Lung Transplantation: The Use of Hepatitis C Positive Donor Lungs in Hepatitis C Negative Recipients
- ClinicalTrials.gov ID
- NCT03377478
- Acronym / sponsor ID
- STUDY19030435
- Conditions
- Hepatitis C, Lung Transplant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Pablo SanchezUniversity, hospital or other
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 21 Sep 2021 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 19 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To perform a study (20 patients) utilizing Hepatitis C positive (HCV Ab+/NAT -) donor lungs for hepatitis C negative recipients with post-operative surveillance and treatment only if a recipient infection occurs.
Detailed description
The investigators are proposing a study of efficacy, in which positive donors will be used for HCV negative patients. Following lung transplantation patients will undergo HCV antibody, virus PCR, and liver function testing. Recipients whom test positive for HCV viremia for 2 consecutive tests at any point will complete 12 weeks of Sofosbuvir/velpatasvir therapy.
This initial study would enroll 20 patients and utilize donors that are young, otherwise healthy whom are Hepatitis C antibody positive but Nucleic Acid Amplification Testing (NAT) negative (HCV Ab+/NAT-). The recipients would be limited to those patients who have previously consented to receive a high risk lung transplant, consented to participant in this study, and who are physiologically optimized for transplantation (e.g., low risk for lung transplantation).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung Transplant | Experimental | Drug: EpclusaPatients will be transplanted with HCV positive lung. Recipients whom test positive for HCV viremia for 2 consecutive tests at any point will complete 12 weeks of Epclusa (Sofosbuvir/velpatasvir). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who sign the informed consent for this study
- Patients whom agree to receive a PHS high risk organ
- Patients listed for heart transplantation
- Age 18-65
Key exclusion criteria (11 listed)
- Patients who do not sign informed consent for this study
- HIV Seropositivity
- HBV Seropositivity (HBcAb and/or HBsAg positive)
- Abnormal liver enzymes - 3 times the normal liver function values (Bilirubin, INR, AST, ALT)
- Acute or chronic renal insufficiency (creatinine clearance <50 ml/min) or history of dialysis
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 |
|---|---|---|
| EpclusaAlso: Procedure, Sofosbuvir/velpatasvirPatients testing positive for HCV viremia will receive 12 weeks of Epclusa. | Drug | Lung Transplant |
Primary outcome
HCV Viremia
Time frame: at 2 years
Incidence of HCV Viremia
Seroconversion
Time frame: at 2 years
Rate of HCV seroconversion
Liver Function Testing
Time frame: at 2 years
Assessment of Hepatic function
Survival
Time frame: at 2 years
Survival rates
2 secondary outcomes
Rejection
Time frame: at 2 years
Waitlist
Time frame: at 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
- SofosbuvirLink provided by the sponsor.
- Drug InformationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Pablo Sanchez, MD principal investigator
Assistant Professor of Surgery/University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Epclusa in people with Hepatitis C and Lung Transplant, run by Pablo Sanchez 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 11 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: finished, as of the sponsor's last update on 16 Dec 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
HCV Viremia (time frame: at 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2022.