Sickle Cell DiseasePhase 3NCT05470998
L-Arginine in Children Having Sickle Cell Disease With Increased Tricuspid Regurgitant Jet Velocity
A Phase 3 study testing L-Arginine in people with Sickle Cell Disease, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to investigate the possible efficacy and safety of L-Arginine in children having Sickle Cell Disease with increased Tricuspid Regurgitant Jet Velocity Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- L-Arginine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jul 2022to 1 Oct 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children having Sickle Cell Disease with increased Tricuspid Regurgitant Jet Velocity
- age 5-18 years
Who cannot join
- Another chronic hemolytic anemia.
- Patients with documented causes of pulmonary hypertension other than SCD.
- Allergy to L-arginine.
- Patients with Asthma.
- Hepatic dysfunction: serum Alanine Aminotransferase (ALT) > 3X upper value.
- Renal dysfunction: Creatinine level greater than or equal to 1.2 mg/dl.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study to Evaluate the Possible Efficacy and Safety of L-Arginine in Children Having Sickle Cell Disease With Increased Tricuspid Regurgitant Jet Velocity
This study aims to investigate the possible efficacy and safety of L-Arginine in children having Sickle Cell Disease with increased Tricuspid Regurgitant Jet Velocity
- Conditions
- Sickle Cell Disease
- Being tested
- L-Arginine
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-ArginineDrug
L-Arginine 1000 mg free form, rapid release capsules
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | this group will include 25 patients who will receive their standard therapy for 3 months |
| L-Arginine group | Active comparator | this group will include 25 patients who will receive L-Arginine 0.1-0.2 g/kg/day and their standard therapy for 3 months Receives: Drug: L-Arginine |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in tricuspid regurgitant jet velocity (TRJV) detected by Color Doppler Echocardiography
patients will undergo Color Doppler Echocardiography to assess tricuspid regurgitant jet velocity (TRJV) at baseline and after 3 months
Measured: 3 months
Secondary outcomes (4)
change in serum level of N-terminal pro b-type natriuretic peptide (NT-pro-BNP)
Blood samples will be collected at baseline and after 3 months
Measured: 3 months
change in serum level of L-Arginine
Blood samples will be collected at baseline and after 3 months
Measured: 3 months
change in serum level of Asymmetric Dimethyl Arginine (ADMA)
Blood samples will be collected at baseline and after 3 months
Measured: 3 months
change in serum level of Nitric Oxide
Blood samples will be collected at baseline and after 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start25 Jul 2022
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Abdelhamid Gomaa, Tanta University
- Investigators
- dalia A gomaa, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05470998
- Sponsor's protocol ID
- L-Arginine 2021
- Status last verified
- Oct 2024
- First submitted
- 17 Jul 2022
- Last updated
- 22 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gomaa DA, El-Haggar SM, El-Shanshory MR, El-Razaky O, El-Afify DR. Clinical Study to Evaluate the Possible Efficacy and Safety of L-Arginine in Children with Sickle Cell Disease and Increased Tricuspid Regurgitant Jet Velocity: a Randomized Controlled Trial. Paediatr Drugs. 2025 Sep;27(5):605-618. doi: 10.1007/s40272-025-00701-w. Epub 2025 Jun 17.
PubMed 40526198
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Possible Efficacy and Safety of L-Arginine in Children Having Sickle Cell Disease With Increased Tricuspid Regurgitant Jet Velocity
- ClinicalTrials.gov ID
- NCT05470998
- Acronym / sponsor ID
- L-Arginine 2021
- Conditions
- Sickle Cell Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 22 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the possible efficacy and safety of L-Arginine in children having Sickle Cell Disease with increased Tricuspid Regurgitant Jet Velocity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –this group will include 25 patients who will receive their standard therapy for 3 months |
| L-Arginine group | Active comparator | Drug: L-Argininethis group will include 25 patients who will receive L-Arginine 0.1-0.2 g/kg/day and their standard therapy for 3 months |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- children having Sickle Cell Disease with increased Tricuspid Regurgitant Jet Velocity
- age 5-18 years
Key exclusion criteria (6 listed)
- Another chronic hemolytic anemia.
- Patients with documented causes of pulmonary hypertension other than SCD.
- Allergy to L-arginine.
- Patients with Asthma.
- Hepatic dysfunction: serum Alanine Aminotransferase (ALT) > 3X upper value.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-ArginineL-Arginine 1000 mg free form, rapid release capsules | Drug | L-Arginine group |
Primary outcome
change in tricuspid regurgitant jet velocity (TRJV) detected by Color Doppler Echocardiography
Time frame: 3 months
patients will undergo Color Doppler Echocardiography to assess tricuspid regurgitant jet velocity (TRJV) at baseline and after 3 months
4 secondary outcomes
change in serum level of N-terminal pro b-type natriuretic peptide (NT-pro-BNP)
Time frame: 3 months
change in serum level of L-Arginine
Time frame: 3 months
change in serum level of Asymmetric Dimethyl Arginine (ADMA)
Time frame: 3 months
change in serum level of Nitric Oxide
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Derived from this study: PubMed 40526198Gomaa DA, El-Haggar SM, El-Shanshory MR, El-Razaky O, El-Afify DR. Clinical Study to Evaluate the Possible Efficacy and Safety of L-Arginine in Children with Sickle Cell Disease and Increased Tricuspid Regurgitant Jet Velocity: a Randomized Controlled Trial. Paediatr Drugs. 2025 Sep;27(5):605-618. doi: 10.1007/s40272-025-00701-w. Epub 2025 Jun 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
dalia A gomaa principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing L-Arginine in people with Sickle Cell Disease, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in tricuspid regurgitant jet velocity (TRJV) detected by Color Doppler Echocardiography (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05470998, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.