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NCT00105235 · ClinicalTrials.gov registry record · Phase 2

Immune System Suppression With Alemtuzumab and Tacrolimus in Liver Transplantation Patients

A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 2
Development phase
27
Enrollment target

NCT00105235: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00105235 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 27 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00105235, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 2
Development phase
27 participants
Enrollment target

Study Summary

Alemtuzumab is a man-made antibody used to treat certain blood disorders. Tacrolimus is a drug used to decrease immune system activity in people who have received organ transplants so that the new organ will not be rejected. This study will determine whether treatment with alemtuzumab and tacrolimus is effective in preventing organ rejection and maintaining the recipient's health after liver transplantation in patients with end-stage liver disease, and whether gradual tapering of tacrolimus treatment is safe for these patients.

Primary Outcome

Proportion of participants who had liver graft loss or who died within 1 year of undergoing transplantation. Note: Participants who discontinued treatment or terminated the study prior to 1 year post transplantation are considered treatment failures and are included in this measure.

Interventions

  • DRUG Alemtuzumab
  • DRUG Tacrolimus
  • DRUG Cyclosporine
  • PROCEDURE Liver transplant
  • DRUG Mycophenolate mofetil

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2005-06
Est. Completion 2011-03
Phase Phase 2

What the finished NCT00105235 record still lists

NCT00105235 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).

The record links to 0 conditions, and to 5 interventions - of which Alemtuzumab is the first listed.

NCT00105235 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00105235 about?

NCT00105235 is a clinical study titled "Immune System Suppression With Alemtuzumab and Tacrolimus in Liver Transplantation Patients". Alemtuzumab is a man-made antibody used to treat certain blood disorders. Tacrolimus is a drug used to decrease immune system activity in people who have received organ transplants so that the new organ will not be rejected. This study will determine whether treatment with alemtuzumab and tacrolimus...

What is the current status of trial NCT00105235?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2005-06. Estimated completion is 2011-03.

What interventions are being tested in trial NCT00105235?

The interventions under investigation include: Alemtuzumab (DRUG), Tacrolimus (DRUG), Cyclosporine (DRUG), Liver transplant (PROCEDURE), Mycophenolate mofetil (DRUG).

Who is sponsoring clinical trial NCT00105235?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00105235's enrollment target sits among peer trials

27 1697th of 2000 higher than 293 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00105235, the US trial registry maintained by the National Library of Medicine. NCT00105235 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.