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COMPLETED Phase 2

Immunosuppression Withdrawal for Stable Pediatric Liver Transplant Recipients

NCT01638559 · View on ClinicalTrials.gov ↗

Study Summary

The primary objective of this study is to assess the efficacy of immunosuppression withdrawal (ISW) in pediatric liver transplant (tx) recipients.

Interventions

  • DRUG Immunosuppression withdrawal

Study Locations (12)

Pennsylvania

  • Children's Hospital of Philadelphia — Philadelphia
  • Children's Hospital of Pittsburgh — Pittsburgh

California

  • University of California — San Francisco

Colorado

  • Children's Hospital of Colorado — Aurora

Georgia

  • Emory University and Children's Hospital of Atlanta — Atlanta

Illinois

  • Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago

Michigan

  • University of Michigan C. S. Mott Children's Hospital — Ann Arbor

Missouri

  • St. Louis Children's Hospital - Washington University — St Louis

New York

  • New York Presbyterian Morgan Stanley Children's Hospital - Columbia University Medical Center — New York

Trial Details

FieldValue
Enrollment Target 161 participants
Start Date 2012-08-14
Est. Completion 2018-06-11
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01638559

The ClinicalTrials.gov registry entry for NCT01638559 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 161 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Liver Transplantation appearing as the primary indexed condition, and to 1 intervention — of which Immunosuppression withdrawal is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01638559 reports 12 study locations spanning 11 distinct geographic areas — top geographies include Pennsylvania, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01638559 about?

NCT01638559 is a clinical study titled "Immunosuppression Withdrawal for Stable Pediatric Liver Transplant Recipients". The primary objective of this study is to assess the efficacy of immunosuppression withdrawal (ISW) in pediatric liver transplant (tx) recipients.

What is the current status of trial NCT01638559?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 161 participants. The study started on 2012-08-14. Estimated completion is 2018-06-11.

What conditions does trial NCT01638559 study?

This clinical trial studies the following conditions: Liver Transplantation, Immunosuppression, Liver Transplant Recipients. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01638559?

The interventions under investigation include: Immunosuppression withdrawal (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01638559?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01638559 being conducted?

This trial has 12 study locations across California, Colorado, Georgia, Illinois, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial