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New treatment option for Liver Transplant
Official title Early Signals of the Transition From Immune Quiescence to Activation in the Liver Allograft Microenvironment and in the Circulation
ClinicalTrials.gov ID: NCT07549503
What this study is testing
- What it's testing
- This is a prospective multi-center, longitudinal study to determine efficacy of 50 percent Immunosuppression (IS) reduction. One hundred fully eligible participants will reduce IS by 50 percent in two steps.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 13
You may be able to join if
- Participant and parent or guardian must be able to understand and provide informed assent and consent, respectively
- Recipient of a living or deceased donor Liver transplant (LTx) at \<7 years of age
- \> 3 years but \<7 years after LTx at the time of study enrollment
- Stable liver tests defined as baseline serum alanine aminotransferase (ALT) level \< 30 IU/l and gamma-glutamyl transferase (GGT) level \< 50 IU/l...
- No Acute rejection (AR) or chronic rejection within 12 months of enrollment
You likely can't join if
- Liver transplant (LTx) for autoimmune disease, including autoimmune hepatitis or primary sclerosing cholangitis
- LTx for hepatitis B or hepatitis C
- Recipient of any other organ transplant or liver re-transplant, except for patients who have a repeat LTx within 30 days of first LTx who are...
- \>=50 percent dose increase in tacrolimus within 12 months of enrollment
- Discontinued a second Immunosuppression (IS) agent within 12 months of enrollment
- Systemic illness requiring chronic or recurrent use of IS for which there is a risk of reactivation if tacrolimus is reduced
See the full eligibility criteria
- Participant and parent or guardian must be able to understand and provide informed assent and consent, respectively
- Recipient of a living or deceased donor Liver transplant (LTx) at \<7 years of age
- \> 3 years but \<7 years after LTx at the time of study enrollment
- Stable liver tests defined as baseline serum alanine aminotransferase (ALT) level \< 30 IU/l and gamma-glutamyl transferase (GGT) level \< 50 IU/l (based on the average of the 3 most recent values prior to screening...
- No Acute rejection (AR) or chronic rejection within 12 months of enrollment
- Tacrolimus monotherapy for \> 6 months with baseline 12-hour trough levels \<8 ng/mL (based on the average of 3 values prior to screening; all must be within 1 year of screening; 2 must be within 6 months of screening)
- Participants of childbearing potential must have a negative pregnancy test upon study entry
- Liver transplant (LTx) for autoimmune disease, including autoimmune hepatitis or primary sclerosing cholangitis
- LTx for hepatitis B or hepatitis C
- Recipient of any other organ transplant or liver re-transplant, except for patients who have a repeat LTx within 30 days of first LTx who are eligible for enrollment
- \>=50 percent dose increase in tacrolimus within 12 months of enrollment
- Discontinued a second Immunosuppression (IS) agent within 12 months of enrollment
- Systemic illness requiring chronic or recurrent use of IS for which there is a risk of reactivation if tacrolimus is reduced
- Use of medication to treat systemic conditions which in the judgement of the investigator could influence results of the study
- Active or chronic infection requiring treatment
- Inability or unwillingness to comply with the study protocol
- Use of investigational drug within 4 weeks (or 5 half-lives of investigational drug, whichever is longer) of enrollment
- Has any condition that, in the opinion of the investigator, will interfere with safe participation in the trial
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Aurora, Colorado, United States
- Washington D.C., District of Columbia, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- New York, New York, United States
- Cincinnati, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 13 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; Aurora, Colorado, United States; Washington D.C., District of Columbia, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States; New York, New York, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.