Aurora, CONCT07549503Now EnrollingIRB Ready

Liver Transplant Clinical Trial in Aurora, CO

Access cutting-edge liver transplant treatment through this clinical trial at a research site in Aurora. Study-provided care at no cost to qualified participants.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Quick Self-Assessment

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Expert Care in Aurora

Access liver transplant specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related liver transplant treatment provided free

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Check if you qualify for this liver transplant clinical trial in Aurora, CO

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Aurora

    Convenient for CO residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Aurora site if eligible
  4. 4Begin participation

About This Liver Transplant Study in Aurora

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 screening, months 6, 12 and 18 after initiating IS dose reduction. A protocol driven liver biopsy to adjudicate the endpoint will be performed at 18 months. The duration of the study from time of starting IS dose reduction to the primary endpoint assessment is 18 months. The primary objective is to assess the efficacy of 50 percent IS dose reduction in children with Liver transplants (LTxs)

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Who Can Participate

Inclusion 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; all must be within 1 year of screening; 2 must be within 6 months of 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

Exclusion Criteria

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Aurora?

Yes, this clinical trial (NCT07549503) has an active research site in Aurora, CO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Liver Transplant Treatment Options in Aurora, CO

If you're searching for liver transplant treatment options in Aurora, CO, this clinical trial (NCT07549503) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Aurora research site is actively enrolling participants for this clinical trial. You'll receive care from experienced liver transplant specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all liver transplant clinical trials near you to find additional studies recruiting in your area.

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