Status:
COMPLETED
Pharmacokinetics of Oral Hydroxyurea Solution
Lead Sponsor:
Nova Laboratories Limited
Conditions:
Sickle Cell Disease
Sickle-Cell; Hemoglobin Disease, Thalassemia
Eligibility:
All Genders
6-17 years
Phase:
PHASE1
PHASE2
Brief Summary
An open label, safety and pharmacokinetic study of oral hydroxyurea solution administered to children from 6 months to 17.99 years (i.e. to the day before 18th birthday), with a 12 to 15 month treatme...
Eligibility Criteria
Inclusion
- Male or female aged from 6 months to 17.99 years of age (i.e. to the day before 18th birthday).
- Diagnosis of sickle cell anemia (HbSS and HbSβº).
- Parent(s)/legal guardian able and willing to provide written informed consent for the child to take part in the study.
- Where applicable, the child should assent to undergo blood sampling for pharmacokinetic and biochemistry purposes and to allow physiological measurements to be made.
Exclusion
- Any clinically significant medical condition or abnormality, which, in the opinion of the Investigator, might have compromised the safety of the patient or which might have interfered with the study.
- Hydroxyurea use within 6 months before enrolment.
- Renal insufficiency (known creatinine more than twice the upper limit of normal (ULN) for age and \>1.0 mg/dL \[88.4 μmol/L\]).
- Clinical evidence of hepatic compromise with alanine aminotransferase (ALT) \>3 times the ULN (a temporary swing in ALT did not result in exclusion).
- Other significant organ system dysfunction based on the site Investigators discretion.
- Severe active infections: fungal, viral or bacterial (as confirmed by culture), examples included tuberculosis, malaria, active hepatitis, osteomyelitis or any other illness that would have precluded the use of HU in normal clinical practice.
- Active chronic leg ulcers.
- Known allergy to oral HU solution or any of the excipients.
- Positive pregnancy test for females of child-bearing potential (in post-menarcheal females) before initiation of treatment, unless participant was sexually abstinent. Note: True abstinence was considered as being in line with the preferred and usual lifestyle of the participant. Periodic abstinence (such as calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- Inadequate contraception measures in sexually active females (post-menarcheal females) and males of child-bearing age (see Section 9.5.1.10.4).
- Breastfeeding at study initiation.
- Participation in another clinical trial of an IMP.
- Known infection with HIV.
Key Trial Info
Start Date :
January 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 29 2021
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT03763656
Start Date
January 3 2019
End Date
December 29 2021
Last Update
October 28 2024
Active Locations (6)
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1
Dr Angela E Rankine- Mullings
Kingston, Jamaica
2
Birmingham Women's and Children's NHS Foundation Trust
Birmingham, United Kingdom
3
Alder Hey Children's NHS Foundation Trust
Liverpool, United Kingdom
4
Evelina London Children's Hospital
London, United Kingdom