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NCT00006136 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of Arginine Butyrate With or Without Epoetin Alfa in Patients With Thalassemia Intermedia
A Phase 2 study, sponsored by Boston University.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT00006136: Completed Phase 2 study, sponsored by Boston University.
NCT00006136 is a Phase 2 study that has completed, run by Boston University. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00006136, a Phase 2 study, has completed, sponsored by Boston University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study Summary
OBJECTIVES: I. Determine whether arginine butyrate with or without epoetin alfa can stimulate gamma-globin chain production to a degree that decreases anemia and results in hematologic improvement in patients with thalassemia intermedia. II. Determine whether a proportional increase in gamma-globin synthesis and mRNA and an improvement in nonalfa and alfaglobin chain imbalance by at least 10% over baseline correlate with improved hematologic response in these patients when treated with this regimen. III. Determine whether a decrease in hemolysis, as assayed by a decrease in LDH, compared to baseline levels correlates with improved hematologic response in these patients when treated with this regimen. IV. Determine whether any particular genotypes are more responsive than others to this therapy in these patients. V. Determine whether baseline epoetin alfa levels, gender, and/or baseline reticulocyte counts (or percent circulating nucleated erythroblasts) correlate with improved hematologic response in these patients when treated with this regimen.
Interventions
- DRUG arginine butyrate
- DRUG epoetin alfa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 1999-03 |
| Phase | Phase 2 |
What the finished NCT00006136 record still lists
NCT00006136 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which arginine butyrate is the first listed.
NCT00006136 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00006136 about?
NCT00006136 is a clinical study titled "Phase II Study of Arginine Butyrate With or Without Epoetin Alfa in Patients With Thalassemia Intermedia". OBJECTIVES: I. Determine whether arginine butyrate with or without epoetin alfa can stimulate gamma-globin chain production to a degree that decreases anemia and results in hematologic improvement in patients with thalassemia intermedia. II. Determine whether a proportional increase in gamma-globin...
What is the current status of trial NCT00006136?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 1999-03.
What interventions are being tested in trial NCT00006136?
The interventions under investigation include: arginine butyrate (DRUG), epoetin alfa (DRUG).
Who is sponsoring clinical trial NCT00006136?
This trial is sponsored by Boston University, which has 185 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00006136's enrollment target sits among peer trials
15 1919th of 2000 higher than 60 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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