Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study that has completed, run by Boston University. The registered enrollment target is 15 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00006136
The ClinicalTrials.gov registry entry for NCT00006136 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston University, which has 185 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which arginine butyrate is the first listed.
NCT00006136 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.