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NCT01290302 · ClinicalTrials.gov registry record · Phase 1
Blinded Cross-Over Bioequivalence (BE) Trial of Luitpold Azacitidine vs Vidaza
A Phase 1 study of Chronic Lymphocytic Leukemia and Myelodysplastic Syndrome, sponsored by American Regent.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT01290302: Completed Phase 1 study of Chronic Lymphocytic Leukemia and Myelodysplastic Syndrome, sponsored by American Regent.
NCT01290302 is a Phase 1 study of Chronic Lymphocytic Leukemia and Myelodysplastic Syndrome that has completed, run by American Regent. The registered enrollment target is 38 participants, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01290302, a Phase 1 study of Chronic Lymphocytic Leukemia and Myelodysplastic Syndrome, has completed, sponsored by American Regent.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to assess the bioequivalence of subcutaneous Vidaza® and subcutaneous Luitpold Azacitidine pharmacokinetics and to assess the comparative safety of subcutaneous Vidaza® versus subcutaneous Luitpold Azacitidine.
Primary Outcome
The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; AUC 0-t is defined as AUC from time 0 to the last data point
Conditions Studied
Interventions
- DRUG Luitpold Azacitidine
- DRUG Vidaza®
Study Locations (1)
Pennsylvania
- Luitpold Pharmaceuticals, Inc. - Norristown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2010-11-22 |
| Est. Completion | 2012-12-21 |
| Phase | Phase 1 |
What the finished NCT01290302 record still lists
NCT01290302 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (79% lower).
The record links to 4 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Luitpold Azacitidine is the first listed.
NCT01290302 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01290302 about?
NCT01290302 is a clinical study titled "Blinded Cross-Over Bioequivalence (BE) Trial of Luitpold Azacitidine vs Vidaza". The purpose of this study is to assess the bioequivalence of subcutaneous Vidaza® and subcutaneous Luitpold Azacitidine pharmacokinetics and to assess the comparative safety of subcutaneous Vidaza® versus subcutaneous Luitpold Azacitidine.
What is the current status of trial NCT01290302?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2010-11-22. Estimated completion is 2012-12-21.
What conditions does trial NCT01290302 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Myelodysplastic Syndrome, Myelofibrosis, Chronic Myeloid Leukemia.
What interventions are being tested in trial NCT01290302?
The interventions under investigation include: Luitpold Azacitidine (DRUG), Vidaza® (DRUG).
Who is sponsoring clinical trial NCT01290302?
This trial is sponsored by American Regent, which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01290302 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT01290302's enrollment target sits among peer trials
38 122nd of 187 higher than 66 of 187 other Chronic Lymphocytic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Lymphocytic Leukemia 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.
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