Early Signals of the Transition From Immune Quiescence to Activation in the Liver Allograft Microenvironment and in the Circulation
Recruiting
Phase 2
Interventional Study
Liver Transplant
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 3 – 13
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 100 (estimated)
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID) · NIH
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About This Trial
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. Liver tests will be checked every 0.5 months through month 4, once a month through month 12, and every other month through month 18. Liver transplant (LTx) center visits will take place at scr…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Participant and parent or guardian must be able to understand and provide informed assent and consent, respectively
2. Recipient of a living or deceased donor Liver transplant (LTx) at \<7 years of age
3. \> 3 years but \<7 years after LTx at the time of study enrollment
4. S…
Contacts