Pharmacokinetics of oral hydroxyurea solutio

Phase 1

• Conditions: Sickle Cell Anaemia; MedDRA version: 20.0 Level: PT Classification code 10040641 Term: Sickle cell anaemia System Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2017-004568-37-GB
• Lead Sponsor: ova Laboratories Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-12
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

1. Male or female aged from 6 months to 17.99 years of age (i.e. to
the day before 18th birthday).
2. Diagnosis of sickle cell anemia (HbSS and HbS0).
3. 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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 25
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Any clinically significant medical condition or abnormality, which, in the opinion of the investigator, might compromise the safety of the patient or which might interfere with the study.
2. Hydroxycarbamide use within 6 months before enrolment.
3. Renal insufficiency (either microalbuminuria, from spot urine or albumin/creatinine ratio [ACR value of > 0.03] and/or Proteinuria, from albumin specific dipstick) (for Proteinuria UTI will be excluded by culture/MSU).
4. Clinical evidence of hepatic compromise with ALT more than 3 times the upper limit of normal (a temporary swing in ALT will not result in exclusion).
5. Other significant organ system dysfunction based on the site investigator’s discretion.
6. Active infections: bacterial (as confirmed by culture), viral or fungal (tuberculosis, malaria, active hepatitis, osteomyelitis);
7. Active chronic leg ulcers.
8. Known allergy to oral hydroxycarbamide solution or any of the excipients.
9. Positive pregnancy test for females of child-bearing potential before initiation of treatment, unless participant is sexually abstinent.
Note: true abstinence is considered as being in line with the preferred and usual lifestyle of the subject. Periodic abstinence (such as calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of
contraception.
10. Inadequate contraception measures in sexually active females and males of child-bearing age (see section 5.12).
11. Currently breastfeeding.
12. Participating in another clinical trial of an IMP.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified