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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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Erythrocyte Glutamine/Glutamate Ratio: a novel biomarker of oxidative stress

Interventions

  • DRUG L-Glutamine

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2009-03
Est. Completion 2014-03
Phase Phase 2

What the finished NCT01048905 record still lists

NCT01048905 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 1 intervention - of which L-Glutamine is the first listed.

NCT01048905 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01048905's enrollment target sits among peer trials

13 1947th of 2000 higher than 53 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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Source: ClinicalTrials.gov NCT01048905, the US trial registry maintained by the National Library of Medicine. NCT01048905 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.