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NCT01231841 · ClinicalTrials.gov registry record · Phase 2

Anti-thymocyte Globulin and Cyclosporine as First-Line Therapy in Treating Patients With Severe Aplastic Anemia

A Phase 2 study of Aplastic Anemia, sponsored by The Cleveland Clinic.

Completed
Registry status
Phase 2
Development phase
20
Enrollment target
1
Study location

NCT01231841: Completed Phase 2 study of Aplastic Anemia, sponsored by The Cleveland Clinic.

NCT01231841 is a Phase 2 study of Aplastic Anemia that has completed, run by The Cleveland Clinic. The registered enrollment target is 20 participants, below the 42-participant average among 23 other Aplastic Anemia trials with a reported enrollment target (52% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01231841, a Phase 2 study of Aplastic Anemia, has completed, sponsored by The Cleveland Clinic.

COMPLETED
Registry status
Phase 2
Development phase
20 participants
Enrollment target
1
Study location

Study Summary

RATIONALE: Immunosuppressive therapies, such as anti-thymocyte globulin and cyclosporine, may improve bone marrow function and increase blood cell counts. PURPOSE: This phase II trial is studying how well giving anti-thymocyte globulin together with cyclosporine as first-line therapy works in treating patients with severe aplastic anemia.

Primary Outcome

Patients will be classified as responders if they have transfusion independence and meet two of the following three criteria: ANC greater than 500/mm3; platelet count greater than 20,000/mm3; and reticulocyte count greater than 40,000/mm3. Transfusion independence is defined as no need for transfusions for one month prior to response assessment.

Conditions Studied

Interventions

  • DRUG cyclosporine
  • BIOLOGICAL anti-thymocyte globulin

Study Locations (1)

Ohio

  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center - Cleveland

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2005-03
Est. Completion 2010-12
Phase Phase 2
The Cleveland Clinic

688 total trials

What the finished NCT01231841 record still lists

NCT01231841 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 42-participant average among 23 other Aplastic Anemia trials with a reported enrollment target (52% lower).

The record links to 1 condition, with Aplastic Anemia appearing as the primary indexed condition, and to 2 interventions - of which cyclosporine is the first listed.

NCT01231841 reports a single indexed study location in Ohio.

Frequently Asked Questions

What is clinical trial NCT01231841 about?

NCT01231841 is a clinical study titled "Anti-thymocyte Globulin and Cyclosporine as First-Line Therapy in Treating Patients With Severe Aplastic Anemia". RATIONALE: Immunosuppressive therapies, such as anti-thymocyte globulin and cyclosporine, may improve bone marrow function and increase blood cell counts. PURPOSE: This phase II trial is studying how well giving anti-thymocyte globulin together with cyclosporine as first-line therapy works in treati...

What is the current status of trial NCT01231841?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2005-03. Estimated completion is 2010-12.

What conditions does trial NCT01231841 study?

This clinical trial studies the following conditions: Aplastic Anemia.

What interventions are being tested in trial NCT01231841?

The interventions under investigation include: cyclosporine (DRUG), anti-thymocyte globulin (BIOLOGICAL).

Who is sponsoring clinical trial NCT01231841?

This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01231841 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Aplastic Anemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01231841's enrollment target sits among peer trials

20 15th of 23 higher than 8 of 23 other Aplastic Anemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Aplastic Anemia 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 NCT01231841, the US trial registry maintained by the National Library of Medicine. NCT01231841 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.