A study of an iron medication to see how well the body tolerates the drug, what the body does to the drug and how safe it is to use at the different strengths in children aged 10-17 years with less iron (with or without anaemia(low number of healthy blood cells))
- Conditions
- MedDRA version: 20.0 Level: PT Classification code 10022972 Term: Iron deficiency anaemia System Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]Iron deficiency (with or without anaemia)MedDRA version: 20.0 Level: LLT Classification code 10002062 Term: Anaemia iron deficiency System Organ Class: 100000012842
- Registration Number
- EUCTR2016-002192-10-GB
- Lead Sponsor
- Shield TX (UK) Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 37
1.Ability to understand the information given in the Independent Ethics Committee (IEC) approved information sheet and consent form. The parent or guardian of the study subject must sign and date the informed consent and authorisation to use protected health information (PHI) in accordance with national and local subject privacy regulations prior to any study mandated procedure. The study participant will be asked to provide their assent to participate in the study using IEC approved assent forms
2.Willing and able to comply with study requirements.
3.Age =10 to =17 years at the time of informed consent and throughout duration of the study.
4.A current diagnosis of iron deficiency (with or without anaemia); iron deficiency defined by ferritin <30 µg/L, or ferritin <50 µg/L with transferrin saturation (TSAT) <20%, as measured by the central laboratory at the Screening visit (subjects with or without anaemia may be enrolled providing Hb is =8.5 g/dL as measured at the Screening visit).
5.Where appropriate, female subjects of childbearing potential must agree to use a reliable method of contraception until study completion and for at least 4 weeks following their final study visit. Reliable contraception is defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly.
Are the trial subjects under 18? yes
Number of subjects for this age range: 36
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Has untreated or untreatable severe malabsorption syndrome e.g., untreated coeliac disease
2.Has received within 28 days prior to screening intramuscular or intravenous (IV) injection or administration of depot iron preparation.
3.Has received oral iron supplementation within 7 days prior to screening
4.Has received blood transfusion within 12 weeks prior to screening or is scheduled to have blood transfusion or donations during the study period.
5.Has concomitant disease that would significantly compromise iron absorption or absorbed iron utilisation such as swallowing disorders and/or extensive small bowel resection.
6.Has chronic renal disease (eGFR <30mL/min), as assessed at Screening based on serum creatinine and ethnicity
7.Known hypersensitivity or allergy to either the active substance or excipients of ferric maltol capsules.
8.Has a known contraindication for treatment with iron preparations , e.g., haemochromatosis, chronic haemolytic disease, sideroblastic anaemia, thalassemia, or lead intoxication induced anaemia.
9.Impaired liver function as indicated by alanine aminotransferase (ALT) or aspartate transaminase (AST)>2.0 times upper normal limit as measured at the Screening visit.
10.Active acute inflammatory disease including IBD flare or disease exacerbation, which in the opinion of the Investigator, is clinically significant.
11.Active chronic or acute infectious diseases requiring antibiotic treatment
12.Pregnant or breast feeding.
13.Concomitant medical conditions with extensive active bleeding, other than menstrual cycles; subjects who suffer from menorrhagia may be excluded at the Investigators discretion.
14.Scheduled or expected hospitalization and/or surgery during the course of the study
15.Participation in any other interventional clinical study within 28 days prior to screening.
16.Cardiovascular, liver, renal, hematologic, psychiatric, neurologic, gastrointestinal, immunologic, endocrine, metabolic, respiratory or central nervous system disease that, in the opinion of the Investigator, may adversely affect the safety of the subject and/or efficacy of the study drug or severely limit the lifespan of the subject.
17. Any other unspecified reason that, in the opinion of the Investigator or the Sponsor make the subject unsuitable for enrolment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method