ClinicalTrials.gg
Status unknownNCT03402191Updated Aug 27, 2018

L-arginine Versus Sildenafil in Children With Beta Thalassemia Associated With Pulmonary Hypertension

A Phase 4 interventional study of L-arginine and Sildenafil in Thalassemia, sponsored by Sherief Abd-Elsalam. Status unknown at 1 site in Egypt. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2018-08-27.

Sponsored by Sherief Abd-Elsalam · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2018), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Jul 2016, registered Jan 2018).

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Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
6 Years to 18 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 17 studies in Thalassemia with a site in Egypt — 2 open to participants now, 2 under way, 1 of them phase 3. Thalassemia · Egypt.

Planned enrollment
10th of 11
60 · median 120
Started
2016
the only one that year
Phase 4
2 of 17
none open now
Registered
9th of 17
by date

Among the 17 studies in Thalassemia with a site in Egypt, this one is the 10th largest by planned enrollment of the 11 interventional ones that give a count, is the only one that started in 2016, is one of 2 in phase 4, and was the 9th registered.

Thalassemia

250 studies on the registry are indexed under Thalassemia; 43 are open to participants now.

Browse Thalassemia studies →

Open to participants now

2 of the 17 studies in Thalassemia with a site in Egypt are open now. Recruiting first, the newest first:

All 2 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 28 Thalassemia studies recruiting now, 7 (25%) set no upper age limit and 18 (64%) stop at 75 or younger; 22 take children under 18; none take healthy volunteers.

This study: 6 Years to 18 Years · all sexes · no healthy volunteers.

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02

Study summary

This study compares L-arginine Versus Sildenafil as treatment for pulmonary hypertension in Children with Beta Thalassemia

Read the detailed description

This study focuses on different lines of treatment for pulmonary hypertension in children with thalassemia as this study discusses the Effect of L-arginine Versus Sildenafil in Children with Beta Thalassemia Associated with Pulmonary Hypertension

03

Conditions studied

  • Thalassemia

Browse trials for

04

Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Children with thalassemia and pulmonary hypertension.

Exclusion criteria

Exclusion Criteria:

  • Rheumatic heart diseases.
  • Other comorbid disease
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    L-arginine

    l-arginine for pulmonary hypertension in patients with thalassemia.

    Drug: L-arginine

  • Active comparator
    Sildenafil

    Sildenafil for pulmonary hypertension in patients with thalassemia.

    Drug: Sildenafil

  • No intervention
    Control

    No pulmonary hypertension

Interventions

  • l-arginine for thalassemia with pulmonary hypertension

  • Sildenafil for thalassemia with pulmonary hypertension

    Also known as: Viagra

06

What researchers measure

Primary outcomes

  1. Number of patients with improvement of pulmonary hypertension

    patients with improvement of pulmonary hypertension

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Sherief Abd-Elsalam
    Tanta, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2016 (actual). Primary completion is estimated for Dec 2023, 89 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 9, 2018
First posted
Jan 18, 2018
StartActual
Jul 2016
Primary completionEst.
Dec 2023
CompletionEst.
Dec 2023
Last update
Aug 27, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03402191
Lead sponsor
Sherief Abd-Elsalam
Responsible party
Sherief Abd-Elsalam (PhDTropical Medicine, Tanta University) — Sponsor-investigator
First posted
Jan 18, 2018
Start date
Jul 2016
Primary completion
Dec 2023 (estimated)
Completion
Dec 2023 (estimated)
Last update
Aug 27, 2018

Study contacts

Sherief Abd-Elsalam, MD
Contact
sheriefabdelsalam@yahoo.com
00201095159522
Sahar El-Haggar, Prof
principal investigator · Tanta University - Faculty of Pharmacy
Mohamed El-Shanshoury, Prof
study director · Tanta University Pediatrics Department
Osama Abd-rab El-Rasol, Prof
study chair · Tanta University Pediatrics Department
Tarek Mostafa, Ass Prof
study chair · Tanta University-Faculty of pharmacy
Eman El-Khateeb, Msc
study chair · Tanta University-Faculty of pharmacy

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Arginine · Sildenafil

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