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NCT01048905 · ClinicalTrials.gov registry record · Phase 2
Glutamine Therapy for Hemolysis-Associated Pulmonary Hypertension
A Phase 2 study, sponsored by UCSF Benioff Children's Hospital Oakland.
- Completed
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT01048905: Completed Phase 2 study, sponsored by UCSF Benioff Children's Hospital Oakland.
NCT01048905 is a Phase 2 study that has completed, run by UCSF Benioff Children's Hospital Oakland. The registered enrollment target is 13 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01048905, a Phase 2 study, has completed, sponsored by UCSF Benioff Children's Hospital Oakland.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study Summary
The primary hypothesis of this study is that glutamine supplementation will improve the erythrocyte glutamine/glutamate ratio, a biomarker of oxidative stress, hemolysis and pulmonary hypertension (PH) in sickle cell disease (SCD) and thalassemia (Thal) patients with PH. PH is defined as a tricuspid regurgitant jet velocity (TRV) on Doppler echocardiography \> 2.5 m/s. We also predict that glutamine therapy will increase arginine bioavailability and subsequently alter sickle red cell endothelial interaction that can be identified using endo-PAT technology through nitric oxide (NO) generation, leading to changes in biological markers, and clinical outcome. Specifically our second hypothesis is that oral glutamine will decrease biomarkers of hemolysis and adhesion molecules, and improve the imbalanced arginine-to-ornithine ratio that occurs in hemolytic anemias, leading to improved arginine bioavailability and clinical endpoints of endothelial dysfunction and PH in patients with SCD and Thal.
Interventions
- DRUG L-Glutamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2009-03 |
| Est. Completion | 2014-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01048905
The ClinicalTrials.gov registry entry for NCT01048905 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UCSF Benioff Children's Hospital Oakland, which has 52 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which L-Glutamine is the first listed.
NCT01048905 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01048905 about?
NCT01048905 is a clinical study titled "Glutamine Therapy for Hemolysis-Associated Pulmonary Hypertension". The primary hypothesis of this study is that glutamine supplementation will improve the erythrocyte glutamine/glutamate ratio, a biomarker of oxidative stress, hemolysis and pulmonary hypertension (PH) in sickle cell disease (SCD) and thalassemia (Thal) patients with PH. PH is defined as a tricuspid...
What is the current status of trial NCT01048905?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2009-03. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01048905?
The interventions under investigation include: L-Glutamine (DRUG).
Who is sponsoring clinical trial NCT01048905?
This trial is sponsored by UCSF Benioff Children's Hospital Oakland, which has 52 total clinical trials registered on ClinicalTrials.gov.
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