Back to resultsL-arginine Versus Sildenafil in Children With Beta Thalassemia Associated With Pulmonary Hypertension
Primary Purpose
Thalassemia
Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
L-arginine
Sildenafil
Sponsored by
About this trial
This is an interventional treatment trial for Thalassemia
Eligibility Criteria
Inclusion Criteria:
- Children with thalassemia and pulmonary hypertension.
Exclusion Criteria:
- Rheumatic heart diseases.
- Other comorbid disease
Sites / Locations
- Sherief Abd-ElsalamRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
L-arginine
Sildenafil
Control
Arm Description
l-arginine for pulmonary hypertension in patients with thalassemia.
Sildenafil for pulmonary hypertension in patients with thalassemia.
No pulmonary hypertension
Outcomes
Primary Outcome Measures
Number of patients with improvement of pulmonary hypertension
patients with improvement of pulmonary hypertension
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03402191
Brief Title
L-arginine Versus Sildenafil in Children With Beta Thalassemia Associated With Pulmonary Hypertension
Official Title
Comparative Clinical Study Evaluating the Effect of L-arginine Versus Sildenafil in Children With Beta Thalassemia Associated With Pulmonary Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Recruiting
Study Start Date
July 2016 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sherief Abd-Elsalam
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study compares L-arginine Versus Sildenafil as treatment for pulmonary hypertension in Children with Beta Thalassemia
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thalassemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
L-arginine
Arm Type
Active Comparator
Arm Description
l-arginine for pulmonary hypertension in patients with thalassemia.
Arm Title
Sildenafil
Arm Type
Active Comparator
Arm Description
Sildenafil for pulmonary hypertension in patients with thalassemia.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No pulmonary hypertension
Intervention Type
Drug
Intervention Name(s)
L-arginine
Intervention Description
l-arginine for thalassemia with pulmonary hypertension
Intervention Type
Drug
Intervention Name(s)
Sildenafil
Other Intervention Name(s)
Viagra
Intervention Description
Sildenafil for thalassemia with pulmonary hypertension
Primary Outcome Measure Information:
Title
Number of patients with improvement of pulmonary hypertension
Description
patients with improvement of pulmonary hypertension
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children with thalassemia and pulmonary hypertension.
Exclusion Criteria:
Rheumatic heart diseases.
Other comorbid disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief Abd-Elsalam, MD
Phone
00201095159522
Email
sheriefabdelsalam@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sahar El-Haggar, Prof
Organizational Affiliation
Tanta University - Faculty of Pharmacy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamed El-Shanshoury, Prof
Organizational Affiliation
Tanta University Pediatrics Department
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Osama Abd-rab El-Rasol, Prof
Organizational Affiliation
Tanta University Pediatrics Department
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tarek Mostafa, Ass Prof
Organizational Affiliation
Tanta University-Faculty of pharmacy
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Eman El-Khateeb, Msc
Organizational Affiliation
Tanta University-Faculty of pharmacy
Official's Role
Study Chair
Facility Information:
Facility Name
Sherief Abd-Elsalam
City
Tanta
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherief Abd-elsalam, lecturer
Phone
00201000040794
Email
Sherif_tropical@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
L-arginine Versus Sildenafil in Children With Beta Thalassemia Associated With Pulmonary Hypertension
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