Is NCT06280950 recruiting in Philadelphia, PA?

Yes, NCT06280950 is currently recruiting participants at its Philadelphia, PA location. This liver transplant clinical trial is actively enrolling qualified participants.

How do I join the liver transplant clinical trial in Philadelphia?

To join this clinical trial in Philadelphia, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Philadelphia clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Liver Transplant Clinical Trial in Philadelphia, PA

About This Liver Transplant Study in Philadelphia

This is a study to determine the safety, efficacy, and tolerability of taking away the anti-rejection medicine, tacrolimus, in liver transplant recipients in conjunction with everolimus monotherapy to preserve renal function. Two hundred - seventy (270) subjects will be randomized 2:1 into one of two groups between 2-3 months post-transplant. Seventy participants will be placed into an observational group and will remain on their current post-transplant medications. The duration of the study fro

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

Who Can Participate

Inclusion Criteria

Subject and/or legal guardian must be able to understand and provide informed consent

Adult (age greater than or equal to 18 years of age at time of informed consent) recipient of first liver transplant alone (de novo)

Estimated glomerular filtration rate \>=30 ml/min/1.73m\^2 at enrollment using the CKD-EPI 2021 equation

Treatment with tacrolimus therapy, with or without mycophenolic acid derivatives and/or corticosteroids

Female subjects of childbearing potential with negative pregnancy test upon study entry

All subjects of reproductive potential agreeing to use contraception for the duration of the study

Previous vaccination or documented immunity to varicella, measles, hepatitis B, pneumococcus, influenza, zoster (if \>=19 years old), and 2019-nCoV (COVID-19) as outlined in the DAIT Vaccination Guideline

Exclusion Criteria

Inability or unwillingness of a participant to give written informed consent or comply with study protocol

Active unresolved systemic viral, bacterial, fungal, or parasitic infection requiring oral or intravenous anti-infective therapy

History of autoimmune liver disease including autoimmune hepatitis, primary sclerosing cholangitis, and/or primary biliary cirrhosis, or other contraindications to drug withdrawal

History of non-hepatic autoimmune disease requiring current or future systemic immunosuppressive therapy other than per study protocol

History post-transplant of Hepatic Artery Thrombosis or Portal Vein Thrombosis.

History of recurrent cirrhosis after liver transplantation.

Chronic use of systemic glucocorticoids, biological immunomodulatory therapy, or other immunosuppressive agents other than per study protocol

History of hepatitis B or C virus infection with detectable viral PCR at enrollment

History of prior organ transplantation (liver or other type)

History of \>= 2 biopsy-proven acute cellular rejection episodes of any severity, \>=1 moderate to severe rejection episode (histologically defined or requiring lymphodepletion therapy), or \>= 1 antibody- mediated rejection episode

Active treatment with any mTOR-inhibitor agent (everolimus, sirolimus)

Contraindication to treatment with everolimus (open wound or wound infection; urine protein: creatinine ratio \> 0.5; significant pancytopenia (any of the following: WBC \<1.5 K/uL or ANC \<1000 cells/uL or actively being treated with GCSF; Hb \<8.0; platelet count \<50K); serum triglycerides \> 1000 mg/dL; other per PI)

Abnormal liver function tests on study entry: Total Bilirubin (TB)\>1.5 mg/dL and Direct Bilirubin (DB) \>1.0 mg/dL, Alkaline Phosphatase (AP) \>200 U/L, and Alanine Aminotransaminase (ALT)\>60 U/L

Pregnant on enrollment or plan to become pregnant during the study period

Participation in another clinical trial that would interfere with this study's procedures and intervention:

Use of investigational biologic or drug (within 8 weeks of study enrollment)

Additional blood collection that would exceed research blood draw limits

Any other procedure or intervention, in the investigator's opinion would interfere with this study

Received live attenuated vaccine(s) within 2 months of enrollment

Current, diagnosed, mental illness or current, diagnosed, or self-reported drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study

Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

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 Philadelphia?

Yes, this clinical trial (NCT06280950) has an active research site in Philadelphia, PA 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 Philadelphia, PA

If you're searching for liver transplant treatment options in Philadelphia, PA, this clinical trial (NCT06280950) 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 Philadelphia research site is actively enrolling participants for this phase 2 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.

Liver Transplant Clinical Trial in Philadelphia, PA

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