Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT03183375 |
Date of registration:
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05/06/2017 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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The Efficacy and Safety of HYDROXYUREA in Management of Beta Thalassemia Patients in Karachi Pakistan
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Scientific title:
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An Open Label Randomized Controlled Trial to Evaluate the Efficacy and Safety of HYDROXYUREA in Management of Beta Thalassemia Patients in Karachi Pakistan |
Date of first enrolment:
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August 21, 2017 |
Target sample size:
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100 |
Recruitment status: |
Recruiting |
URL:
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https://clinicaltrials.gov/show/NCT03183375 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Pakistan
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Contacts
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Name:
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Saqib H Ansari, MBBS, DCH, DPGN, Mphil, PhD |
Address:
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Telephone:
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+93002118018 |
Email:
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muddasirsaqib@yahoo.com |
Affiliation:
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Name:
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Saqib H Ansari, MBBS, DCH, DPGN, Mphil, PhD |
Address:
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Telephone:
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03002118018 |
Email:
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muddasirsaqib@yahoo.com |
Affiliation:
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Name:
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Saqib H Ansari, MBBS, DCH, DPGN, Mphil, PhD |
Address:
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Telephone:
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Email:
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Affiliation:
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Omair Sana Foundation |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with homozygous beta thalassemia major diagnosed on the basis of genetic
mutation
- Beta thalassemia intermedia (patients carrying homozygous, heterozygous or compound
heterozygous beta thalassemia genes) (HbS, HbE)
- Those patients who do not have baseline HbE suggestive of beta thalassemia, genetic
mutations will be performed to confirm the diagnosis.
- Age: 6 months and onwards
- Gender: Either
- Able to understand study procedures and to comply with them for the entire length of
the study.
- Provide written informed consent if aged 18 years and above and if minor that is below
18 years (Parental consent will be taken)
Exclusion Criteria:
- Chronic liver disease, renal failure, history of stroke
- Participants who have developed immune hemolytic anemia
- Spleenomegaly (liver and spleen >5 cm below coastal margin
- If allergic or sensitive to Hydroxyurea or its ingredients
- Patients on immunosuppressants including Azathiopine or any other drug causing bone
marrow suppression, Hepatitis C treatment that may cause red cell suppression and
NSAIDS
- Inability or unwillingness of individual or legal guardian/representative to give
written informed consent.
Age minimum:
6 Months
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Thalassemia, Beta
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Intervention(s)
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Drug: Hydroxyurea
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Primary Outcome(s)
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No. of participants who become responders or partial responders
[Time Frame: 6 months]
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Secondary Outcome(s)
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Number of participants with abnormal/deranged laboratory values
[Time Frame: 6 months]
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No. of participants with severe adverse events related to the intervention
[Time Frame: 6 months]
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The compliance of Hydroxyurea in study participants.
[Time Frame: 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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