Liver TransplantPhase 1/2LITTMUS-UCSFNCT03654040
Liver Transplantation With Tregs at UCSF
A Phase 1/2 study testing arTreg, leukapheresis and cyclophosphamide in people with Liver Transplant, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
This is a single-center, prospective, open-label, non-randomized clinical trial exploring cellular therapy to facilitate immunosuppression withdrawal in liver transplant recipients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Transplant
- What is being tested?
- arTreg, leukapheresis and cyclophosphamide
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2021to 6 Mar 2023
- Phase
- Phase 1/2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligibility:
- Recipient:
- Individuals must meet all of the following criteria to be eligible for this study:
- Able to understand and provide informed consent
- End-stage liver disease and listed for a living or deceased-donor primary solitary liver transplant
- Agreement to use contraception
Show all 22Show fewer
- For candidates with a history of hepatitis C virus (HCV), completed treatment for HCV, maintaining a sustained viral response of ≥24 weeks duration by the day of transplant
- Positive Epstein-Barr virus (EBV) antibody test, and
- Immunizations are up-to-date based on the Advisory Committee on Immunization Practices (ACIP) recommendations for individuals with Liver Disease and Adult Vaccination, unless the investigator determines that administering a recommended immunization is not in the patient's best interest.
- Living Donor:
- Living donors must meet all of the following criteria to be eligible for this study:
- Able to understand and provide informed consent
- Meets site-specific clinical donor eligibility requirements
- Meets donor eligibility manufacturing requirements within 7 days before or after the blood collection for manufacturing, and
- Willingness to donate appropriate biologic samples.
- Deceased Donor:
- Deceased donors must meet the following criteria for their recipients to remain eligible:
- Meets site-specific clinical donor eligibility requirements and
- Meets donor eligibility manufacturing requirements.
- Note:
- There are several stages to this study.
- Eligibility is evaluated at many time points during the study to assess whether a participant is safe to proceed to the next study stage.
Who cannot join
- Recipient:
- Individuals who meet any of the following criteria will not be eligible for this study:
- History of previous organ, tissue or cell transplant
- For cytomegalovirus (CMV) antibody negative recipients, a (CMV) antibody positive donor
- Known contraindication to cyclophosphamide or mesna
- Serologic evidence of human immunodeficiency virus (HIV)-1/2 infection
Show all 25Show fewer
- The need for chronic anti-coagulation or anti-platelet agents other than aspirin that cannot be safely discontinued for a minimum of 1 week to safely perform a liver biopsy
- End stage liver disease secondary to autoimmune etiology (autoimmune hepatitis, primary biliary cirrhosis, or primary sclerosing cholangitis) or other contraindications to drug withdrawal
- Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up visit schedule
- Any condition that, in the opinion of the investigator, may interfere with study compliance
- History of cardiac disease (ischemic heart disease requiring revascularization, history of or current treatment for dysrhythmia, or evidence of congestive heart failure), unless cleared by a cardiologist
- Any past or current medical problems, treatments or findings that are not listed above, which, in the opinion of the investigator, may:
- pose additional risks from participation in the study,
- interfere with the candidate's ability to comply with study requirements, or
- impact the quality or interpretation of the data obtained from the study.
- This includes past, present or future enrollment in studies that affect eligibility at the time of everolimus (EVR) conversion
- History of malignancy or any concomitant malignancy, except:
- hepatocellular carcinoma,
- completely treated in-situ cervical carcinoma, or
- completely treated basal cell carcinoma.
- Chronic use of systemic glucocorticoids or other immunosuppressives, or biologic immunomodulators.
- Living Donor:
- There are no exclusion criteria for living donors.
- Deceased Donor:
- -There are no exclusion criteria for deceased donors.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: A Phase I/II Drug Withdrawal Study of Alloantigen-Specific Tregs in Liver Transplantation
This is a single-center, prospective, open-label, non-randomized clinical trial exploring cellular therapy to facilitate immunosuppression withdrawal in liver transplant recipients.
Read the detailed description
The researchers in this study plan to enroll 9 participants. Eligible participants will receive a single dose of Treg product (arTreg). The target dose is at least 90 to 500 x 10^6 total cells.
Participants who successfully withdraw from all immunosuppression (IS) will undergo a research biopsy at 52 weeks following IS discontinuation to determine whether they meet the primary efficacy outcome of operational tolerance. Participants determined to be operationally tolerant will be followed until 104 weeks following IS discontinuation. Participants who fail drug withdrawal after 52 weeks but before 104 weeks will be followed until week 104 or 12 weeks after resuming immunosuppression, whichever is longer.
Participants who do not successfully withdraw from all IS will complete 104 weeks of High Intensity Safety Follow-up after failing immunosuppression withdrawal.
- IMPORTANT NOTICE: * The National Institute of Allergy and Infectious Diseases and the Immune Tolerance Network do not recommend the discontinuation of immunosuppressive therapy for recipients of cell, organ, or tissue transplants outside of physician-directed, controlled clinical studies. Discontinuation of prescribed immunosuppressive therapy can result in serious health consequences and should only be performed in certain rare circumstances, upon the recommendation and with the guidance of your health care provider.
- Conditions
- Liver Transplant
- Being tested
- arTreg, leukapheresis, cyclophosphamide, mesna, everolimus
- Keywords
- alloantigen-reactive Tregs (arTreg), immunosuppression, operational tolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arTregBiological
Also called donor alloantigen-reactive regulatory T cells, CD4+CD25+CD127[lo] Treg cells
Eligible participants will receive a single dose of Treg product (arTreg). The target dose is at least 90 x 10^6 total cells.
Method of receipt: peripheral intravenous (IV) infusion, administered over 20 to 30 minutes.
leukapheresisProcedure or surgery
Also called apheresis
Leukapheresis will be the method employed to recover peripheral blood mononuclear cells (PBMCs) from the allograft recipient. The recipient will undergo the procedure prior to initiating the cyclophosphamide conditioning regimen.
Procedure on Day -3 (-1 day) prior to Treg product (arTreg) IV infusion.
cyclophosphamideDrug
Also called Cytoxan®, CTX
40 mg/kg administered intravenously (IV) following leukapheresis and between 1 to 3 days prior to Treg product (arTreg) infusion, per institutional standard of care.
mesnaDrug
Also called Mesnex®
Mesna is administered:
- Intravenously to inhibit hemorrhagic cystitis induced by cyclophosphamide, and
- In conjunction with the cyclophosphamide, per institutional practice with CTX.
everolimusDrug
Also called EVR, Afinitor®, Zortress®
EVR is approved for prophylaxis of allograft rejection in adults receiving a liver transplant. Per protocol: Post transplantation, subject will initially receive standard IS with tacrolimus (TAC),plus a mycophenolate product and/or steroids.Subsequently, evaluation for eligibility to be converted to EVR-based IS regimen will occur and, when applicable, proceed. Once the optimal EVR trough level is achieved,TAC dose will be reduced. When target EVR and TAC levels are maintained over two consecutive measurements, ALT liver function test (LFT) is ≤50 U/L, GGT LFT is ≤ the upper limit of normal or ≤ 1.5 times the baseline GGT, subject will be considered successfully converted to EVR-based IS regimen. EVR doses will be administered/monitored/adjusted over time.
| Study group | Role | What they receive |
|---|---|---|
| arTreg | Experimental | arTreg: alloantigen-reactive T regulatory cells
The investigational product is donor alloantigen-reactive regulatory T cells (arTreg). Supportive regimen for receipt of arTregs includes everolimus, leukapheresis, cyclophosphamide, and mesna.
Note: Participants who receive at least the minimum Treg product (arTreg) dose of 30 to <90 x10^6 total cells will be included in intent-to-treat analysis. Receives: Biological: arTreg; Procedure: leukapheresis; Drug: cyclophosphamide; Drug: mesna; Drug: everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Severity of Adverse Events (AEs) Attributed to the Investigational Product, arTreg
- AEs will be attributed to alloantigen-reactive Tregs (arTreg) when the AE is reported with possible or related attribution to arTreg.
- Grading: According to the NCI Common Terminology Criteria for Adverse Events Manual [NCI-CTCAE version 5.0, published November 27, 2017].
Measured: From arTreg infusion through completion of study participation
Number and Severity of Adverse Events (AEs) Attributed to Supportive Regimen: Leukapheresis, Cyclophosphamide or Mesna
- AEs will be attributed to the supportive regimen for this study when the AE is reported with possible or related attribution to leukapheresis, cyclophosphamide, or mesna.
- Grading: According to the NCI Common Terminology Criteria for Adverse Events Manual [NCI-CTCAE version 5.0, published November 27, 2017].
Measured: From ≤3 days prior to arTreg infusion through completion of study participation (Up to 3 months)
Number of Operationally Tolerant Participants
Operational tolerance is defined as:
- Discontinuation of all immunosuppression (IS) for 52 weeks,
- Alanine aminotransferase (ALT) and gamma-glutamyl transpeptidase (GGT) ≤ 50 U/L for ≥ 2 measurements separated by ≥1 week in the 6 weeks prior to the liver biopsy at 52 weeks after the last IS dose, and
- Liver biopsy at 52 weeks (±4 weeks) after the last IS dose that meets the biopsy criteria for operational tolerance, as assessed by central pathology.
Measured: 52 (± 4 weeks) after the last dose of immunosuppression
Secondary outcomes (7)
Number of Participants Who Develop a Malignancy
The number of participants that are diagnosed with malignancy, any type.
Measured: Time of enrollment through completion of study participation (Up to 1.8 years)
Incidence of ≥Grade 3 Infections Following arTreg Infusion
Grading: According to the NCI Common Terminology Criteria for Adverse Events Manual [NCI-CTCAE version 5.0, published November 27, 2017].
Measured: From arTreg infusion through completion of study participation
Number of Biopsy-Proven Acute Rejection (AR) and/or Clinical Rejection Events at Any Time After Alloantigen-Reactive Tregs (arTreg) Infusion
Definitions:
- AR: Diagnosed in accordance with Banff global assessment criteria
- Clinical Rejection: Participants who are treated empirically based on investigator clinical suspicion in cases where a biopsy is indeterminate or in rare cases, where a biopsy cannot be performed.
Measured: From arTreg infusion through completion of study participation
Severity of Biopsy-Proven Acute Rejection (AR) and/or Clinical Rejection Events at Any Time After Alloantigen-Reactive Tregs (arTreg) Infusion
Intensity of AR and/or clinical rejection events will be graded.
Definitions:
- AR: Diagnosed in accordance with Banff global assessment criteria
- Clinical Rejection: Participants who are treated empirically based on investigator clinical suspicion in cases where a biopsy is indeterminate or in rare cases, where a biopsy cannot be performed.
Measured: From arTreg infusion through completion of study participation
Number of Chronic Rejection Events at Any Time After Alloantigen-Reactive Tregs (arTreg) Infusion
Diagnosed in accordance with Banff global assessment criteria.
Measured: From arTreg infusion through completion of study participation
Proportion of Participants Who Successfully Discontinue Tacrolimus
Proportion of participants who, per protocol:
- fulfill eligibility for tacrolimus withdrawal,
- subsequently achieve their last dose of tacrolimus,
- remain tacrolimus-free for ≥12 weeks,
- their liver function tests, ALT and GGT, are ≤50 U/L,
- and their liver biopsy performed between 12 to 26 weeks status post the last dose of tacrolimus fulfills biopsy findings* for minimization of immunosuppression.
- Biopsy findings: Liver histology will be assessed by central pathology. Biopsy findings for minimization of immunosuppression, per protocol. Reference: Demetris AJ, Bellamy C, Hubscher SG, et al. 2016 Comprehensive Update of the Banff Working Group on Liver Allograft Pathology: Introduction of Antibody-Mediated Rejection. Am J Transplant 2016.
Measured: Post-transplant through Completion of Study Participation
Duration of Operational Tolerance
Durability of operational tolerance defined as the time from achieving the primary endpoint to immunosuppression (IS) reinitiation or to the end of trial participation.
Measured: Post-transplant through Completion of Study Participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start22 Apr 2021
- Primary completion6 Mar 2023
- Study completion6 Mar 2023
Why it stopped: The study was terminated by the Sponsor prior to any participants receiving the investigational product.
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 Liver TransplantStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Immune Tolerance Network (ITN), PPD Development, LP, Rho Federal Systems Division, Inc.
- Responsible party
- Sponsor
- Investigators
- Sandy Feng, MD, PhD, Study chair, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03654040
- Sponsor's protocol ID
- DAIT ITN074ST
- Other IDs
- UM1AI109565, NIAID CRMS ID#: 38481
- Acronym
- LITTMUS-UCSF
- Status last verified
- Apr 2024
- First submitted
- 28 Aug 2018
- Last updated
- 23 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The plan is to share data upon completion of the study in ImmPort, a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Drug Withdrawal Study of Alloantigen-Specific Tregs in Liver Transplantation
- ClinicalTrials.gov ID
- NCT03654040
- Acronym / sponsor ID
- LITTMUS-UCSF / DAIT ITN074ST
- Conditions
- Liver Transplant
- Keywords
- alloantigen-reactive Tregs (arTreg), immunosuppression, operational tolerance
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated by the Sponsor prior to any participants receiving the investigational product.
- Enrolment
- 42 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Immune Tolerance Network (ITN), PPD Development, LP, Rho Federal Systems Division, Inc.
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 6 Mar 2023 (actual)
- Study completion
- 6 Mar 2023 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Posted 23 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, prospective, open-label, non-randomized clinical trial exploring cellular therapy to facilitate immunosuppression withdrawal in liver transplant recipients.
Detailed description
The researchers in this study plan to enroll 9 participants. Eligible participants will receive a single dose of Treg product (arTreg). The target dose is at least 90 to 500 x 10^6 total cells.
Participants who successfully withdraw from all immunosuppression (IS) will undergo a research biopsy at 52 weeks following IS discontinuation to determine whether they meet the primary efficacy outcome of operational tolerance. Participants determined to be operationally tolerant will be followed until 104 weeks following IS discontinuation. Participants who fail drug withdrawal after 52 weeks but before 104 weeks will be followed until week 104 or 12 weeks after resuming immunosuppression, whichever is longer.
Participants who do not successfully withdraw from all IS will complete 104 weeks of High Intensity Safety Follow-up after failing immunosuppression withdrawal.
- IMPORTANT NOTICE: * The National Institute of Allergy and Infectious Diseases and the Immune Tolerance Network do not recommend the discontinuation of immunosuppressive therapy for recipients of cell, organ, or tissue transplants outside of physician-directed, controlled clinical studies. Discontinuation of prescribed immunosuppressive therapy can result in serious health consequences and should only be performed in certain rare circumstances, upon the recommendation and with the guidance of your health care provider.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| arTreg | Experimental | Biological: arTreg, Procedure: leukapheresis, Drug: cyclophosphamide, Drug: mesna, Drug: everolimusarTreg: alloantigen-reactive T regulatory cells The investigational product is donor alloantigen-reactive regulatory T cells (arTreg). Supportive regimen for receipt of arTregs includes everolimus, leukapheresis, cyclophosphamide, and mesna. Note: Participants who receive at least the minimum Treg product (arTreg) dose of 30 to <90 x10^6 total cells will be included in intent-to-treat analysis. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Individuals must meet all of the following criteria to be eligible for this study:
- Living donors must meet all of the following criteria to be eligible for this study:
- Meets site-specific clinical donor eligibility requirements and
- Meets donor eligibility manufacturing requirements.
- There are several stages to this study.
Key exclusion criteria (25 listed)
- Individuals who meet any of the following criteria will not be eligible for this study:
- There are no exclusion criteria for living donors.
- -There are no exclusion criteria for deceased donors.
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 |
|---|---|---|
| arTregAlso: donor alloantigen-reactive regulatory T cells, CD4+CD25+CD127[lo] Treg cellsEligible participants will receive a single dose of Treg product (arTreg). The target dose is at least 90 x 10^6 total cells. Method of receipt: peripheral intravenous (IV) infusion, administered over 20 to 30 minutes. | Biological | arTreg |
| leukapheresisAlso: apheresisLeukapheresis will be the method employed to recover peripheral blood mononuclear cells (PBMCs) from the allograft recipient. The recipient will undergo the procedure prior to initiating the cyclophosphamide conditioning regimen. Procedure on Day -3 (-1 day) prior to Treg product (arTreg) IV infusion. | Procedure or surgery | arTreg |
| cyclophosphamideAlso: Cytoxan®, CTX40 mg/kg administered intravenously (IV) following leukapheresis and between 1 to 3 days prior to Treg product (arTreg) infusion, per institutional standard of care. | Drug | arTreg |
| mesnaAlso: Mesnex®Mesna is administered: * Intravenously to inhibit hemorrhagic cystitis induced by cyclophosphamide, and * In conjunction with the cyclophosphamide, per institutional practice with CTX. | Drug | arTreg |
| everolimusAlso: EVR, Afinitor®, Zortress®EVR is approved for prophylaxis of allograft rejection in adults receiving a liver transplant. Per protocol: Post transplantation, subject will initially receive standard IS with tacrolimus (TAC),plus a mycophenolate product and/or steroids.Subsequently, evaluation for eligibility to be converted to EVR-based IS regimen will occur and, when applicable, proceed. Once the optimal EVR trough level is achieved,TAC dose will be reduced. When target EVR and TAC levels are maintained over two consecutive measurements, ALT liver function test (LFT) is ≤50 U/L, GGT LFT is ≤ the upper limit of normal or ≤ 1.5 times the baseline GGT, subject will be considered successfully converted to EVR-based IS regimen. EVR doses will be administered/monitored/adjusted over time. | Drug | arTreg |
Primary outcome
Number and Severity of Adverse Events (AEs) Attributed to the Investigational Product, arTreg
Time frame: From arTreg infusion through completion of study participation
* AEs will be attributed to alloantigen-reactive Tregs (arTreg) when the AE is reported with possible or related attribution to arTreg. * Grading: According to the NCI Common Terminology Criteria for Adverse Events Manual [NCI-CTCAE version 5.0, published November 27, 2017].
Number and Severity of Adverse Events (AEs) Attributed to Supportive Regimen: Leukapheresis, Cyclophosphamide or Mesna
Time frame: From ≤3 days prior to arTreg infusion through completion of study participation (Up to 3 months)
* AEs will be attributed to the supportive regimen for this study when the AE is reported with possible or related attribution to leukapheresis, cyclophosphamide, or mesna. * Grading: According to the NCI Common Terminology Criteria for Adverse Events Manual [NCI-CTCAE version 5.0, published November 27, 2017].
Number of Operationally Tolerant Participants
Time frame: 52 (± 4 weeks) after the last dose of immunosuppression
Operational tolerance is defined as: * Discontinuation of all immunosuppression (IS) for 52 weeks, * Alanine aminotransferase (ALT) and gamma-glutamyl transpeptidase (GGT) ≤ 50 U/L for ≥ 2 measurements separated by ≥1 week in the 6 weeks prior to the liver biopsy at 52 weeks after the last IS dose, and * Liver biopsy at 52 weeks (±4 weeks) after the last IS dose that meets the biopsy criteria for operational tolerance, as assessed by central pathology.
7 secondary outcomes
Number of Participants Who Develop a Malignancy
Time frame: Time of enrollment through completion of study participation (Up to 1.8 years)
Incidence of ≥Grade 3 Infections Following arTreg Infusion
Time frame: From arTreg infusion through completion of study participation
Number of Biopsy-Proven Acute Rejection (AR) and/or Clinical Rejection Events at Any Time After Alloantigen-Reactive Tregs (arTreg) Infusion
Time frame: From arTreg infusion through completion of study participation
Severity of Biopsy-Proven Acute Rejection (AR) and/or Clinical Rejection Events at Any Time After Alloantigen-Reactive Tregs (arTreg) Infusion
Time frame: From arTreg infusion through completion of study participation
Number of Chronic Rejection Events at Any Time After Alloantigen-Reactive Tregs (arTreg) Infusion
Time frame: From arTreg infusion through completion of study participation
Proportion of Participants Who Successfully Discontinue Tacrolimus
Time frame: Post-transplant through Completion of Study Participation
Duration of Operational Tolerance
Time frame: Post-transplant through Completion of Study Participation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
- Division of Allergy, Immunology, and Transplantation (DAIT)Link provided by the sponsor.
- Immune Tolerance Network web siteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The plan is to share data upon completion of the study in ImmPort, a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
Related trials for Liver Transplant
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
RecruitingPhase 2
Expanding Liver Transplant Immunosuppression Minimization Via Everolimus
Liver Transplant
RecruitingObservational study
Long-term Follow-up (LTFU) Study of Participants in Any iECURE Protocol Using an Investigational Product (IP)
Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease
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.
Sandy Feng, MD, PhD study chair
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing arTreg, leukapheresis and cyclophosphamide in people with Liver Transplant, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 22 inclusion and 25 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 23 Apr 2024. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 23 Apr 2024). 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 and Severity of Adverse Events (AEs) Attributed to the Investigational Product, arTreg (time frame: From arTreg infusion through completion of study participation). 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?
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 23 Apr 2024.