Pharmacokinetics of Oral Hydroxyurea Solution

  • STATUS
    Recruiting
  • End date
    Jun 10, 2022
  • participants needed
    25
  • sponsor
    Nova Laboratories Limited
Updated on 10 March 2021
anemia
hydroxyurea

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 15 month treatment period for each participant. The study treatment duration will be for 6 months at the maximum tolerated dose [MTD], which is usually reached by 6 months after initiation of treatment. For patients in whom time to MTD is longer than 6 months or not achieved at all, the maximum duration of study treatment will be 15 months.

Details
Condition SICKLE CELL ANEMIA, Sickle Cell Disease, hbsc, Sickle-Cell; Hemoglobin Disease, Thalassemia, Sickle Cell-beta-thalassemia, Sickle-Cell; Hemoglobin Disease, Thalassemia, Sickle Cell-beta-thalassemia, Sickle-Cell; Hemoglobin Disease, Thalassemia, Sickle Cell-beta-thalassemia
Treatment Hydroxy Urea, Hydroxy Urea
Clinical Study IdentifierNCT03763656
SponsorNova Laboratories Limited
Last Modified on10 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 1 yrs and 17 yrs?
Gender: Male or Female
Do you have any of these conditions: Sickle Cell-beta-thalassemia or SICKLE CELL ANEMIA or Sickle-Cell; Hemoglobin Disease, Thalassemia or Sickle Cell Disease or hbsc?
Do you have any of these conditions: Sickle Cell Disease or SICKLE CELL ANEMIA or hbsc or Sickle-Cell; Hemoglobin Disease, Thalassemia or Sickle Cell-beta-thalassemia?
Do you have any of these conditions: Sickle Cell Disease or hbsc or SICKLE CELL ANEMIA or Sickle-Cell; Hemoglobin Disease, Thalassemia or Sickle Cell-beta-thalassemia?
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 HbS)
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 Criteria

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
Hydroxyurea use within 6 months before enrolment
Renal insufficiency (known creatinine more than twice the upper limit for age and >1.0mg/dL [88.4 micromol/L]))
Clinical evidence of hepatic compromise with ALT more than 3 times the upper limit of normal
Other significant organ system dysfunction based on the site investigator's discretion
Severe active infections: fungal, viral or bacterial (as confirmed by culture), examples include tuberculosis, malaria, active hepatitis, osteomyelitis or any other illness that would preclude the use of hydroxyurea in normal clinical practice
Active chronic leg ulcers
Known allergy to oral hydroxyurea 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 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
Inadequate contraception measures in sexually active females (in post-menarcheal females) and males of child bearing age
Currently breastfeeding
Participating in another clinical trial of an IMP
Known infection with Human Immunodeficiency Virus (HIV)
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