NCT03402191

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2016

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 18, 2018

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

August 27, 2018

Status Verified

August 1, 2018

Enrollment Period

7.4 years

First QC Date

January 9, 2018

Last Update Submit

August 23, 2018

Conditions

Thalassemia

Outcome Measures

Primary Outcomes (1)

  • Number of patients with improvement of pulmonary hypertension

    patients with improvement of pulmonary hypertension

    6 months

Study Arms (3)

L-arginine

ACTIVE COMPARATOR

l-arginine for pulmonary hypertension in patients with thalassemia.

Drug: L-arginine

Sildenafil

ACTIVE COMPARATOR

Sildenafil for pulmonary hypertension in patients with thalassemia.

Drug: Sildenafil

Control

NO INTERVENTION

No pulmonary hypertension

Interventions

L-arginineDRUG

l-arginine for thalassemia with pulmonary hypertension

L-arginine
SildenafilDRUG

Sildenafil for thalassemia with pulmonary hypertension

Also known as: Viagra
Sildenafil

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children with thalassemia and pulmonary hypertension.

You may not qualify if:

  • Rheumatic heart diseases.
  • Other comorbid disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sherief Abd-Elsalam

Tanta, Egypt

RECRUITING

MeSH Terms

Conditions

Thalassemia

Interventions

ArginineSildenafil Citrate

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Amino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, EssentialSulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Sahar El-Haggar, Prof

    Tanta University - Faculty of Pharmacy

    PRINCIPAL INVESTIGATOR

  • Mohamed El-Shanshoury, Prof

    Tanta University Pediatrics Department

    STUDY DIRECTOR

  • Osama Abd-rab El-Rasol, Prof

    Tanta University Pediatrics Department

    STUDY CHAIR

  • Tarek Mostafa, Ass Prof

    Tanta University-Faculty of pharmacy

    STUDY CHAIR

  • Eman El-Khateeb, Msc

    Tanta University-Faculty of pharmacy

    STUDY CHAIR

Central Study Contacts

Sherief Abd-Elsalam, MD

CONTACT

00201095159522sheriefabdelsalam@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhDTropical Medicine

Study Record Dates

First Submitted

January 9, 2018

First Posted

January 18, 2018

Study Start

July 1, 2016

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

August 27, 2018

Record last verified: 2018-08

Locations

EG(1)