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Evaluate the PK, Safety, Tolerability of Ferric Maltol at 3 Dosage Levels in Paediatric Subjects With Iron Deficiency

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ClinicalTrials.gov Identifier: NCT03181451
Recruitment Status : Completed
First Posted : June 8, 2017
Last Update Posted : May 31, 2018
Sponsor:
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
Shield Therapeutics

Brief Summary:
The study has been designed to establish the pharmacokinetics (PK) and iron uptake of Ferric Maltol in children and adolescents aged 10-17 years using two (2) lower dose strengths in comparison to the EU-approved 30mg BID dose in adults with IDA in IBD.

Condition or disease Intervention/treatment Phase
Iron Deficiency, Anaemia in Children Iron-Deficiency Drug: Ferric Maltol Phase 1

Detailed Description:

Phase I, open label, randomized, repeat dose, multicentre, pharmacokinetic study to assess the Safety and Tolerability of Ferric Maltol in 3 different dosages.

36 eligible patients will be randomized in a 1:1:1 ratio to one of the following 3 dosages for 9 days BID and a single dose on Day 10:

  • 30mg ferric maltol capsules
  • 16.6 mg ferric maltol capsules
  • 7.8 mg ferric maltol capsules

Subject participation in the study will consist of 3 stages:

Screening: up to 14 days Treatment period: 10 days treatment period with 2 visits on Day 1 and Day 10 for PK blood sampling. Patients will be randomly allocated to one of the three Ferric Maltol dose groups according to centralized treatment allocation scheme.

Post-treatment Safety Follow-up:3-10 days following completion of the treatment period or premature discontinuation of study medication


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized in a 1:1:1 ratio and stratified by co-variates for age and sex. This will ensure that a minimum of 25% of each gender and at least 3 children per age group are enrolled in each Ferric Maltol dose group.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Phase 1, Open-Label, Randomised, Repeat Dose, Parallel Group Study to Evaluate the PK, Safety, Tolerability of Ferric Maltol at 3 Dosage Levels in Paediatric Subjects Aged 10-17 Years of Age With Iron Deficiency
Actual Study Start Date : March 14, 2017
Actual Primary Completion Date : March 28, 2018
Actual Study Completion Date : March 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Active Comparator: 30 mg Ferric Maltol
12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30mg dose on the morning of Day 10. PK study Day 1 & Day 10.
Drug: Ferric Maltol
To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Other Names:
  • ST10
  • Feraccru

Active Comparator: 16.6 mg Ferric Maltol
12 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6mg dose on the morning of Day 10. PK study Day 1 & Day 10.
Drug: Ferric Maltol
To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Other Names:
  • ST10
  • Feraccru

Active Comparator: 7.8 mg Ferric Maltol
12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8mg dose on the morning of Day 10. PK study Day 1 & Day 10.
Drug: Ferric Maltol
To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Other Names:
  • ST10
  • Feraccru




Primary Outcome Measures :
  1. Maximum Plasma Concentration [Cmax] of maltol on Day 1 [ Time Frame: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of maltol Cmax from PK samples collected on Day 1

  2. Maximum Plasma Concentration [Cmax] of maltol glucuronide on Day 1 [ Time Frame: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of maltol glucuronide Cmax from PK samples collected on Day 1

  3. Maximum Plasma Concentration [Cmax] of maltol on Day 10 [ Time Frame: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of maltol Cmax from PK samples collected on Day 10

  4. Maximum Plasma Concentration [Cmax] of maltol glucuronide on Day 10 [ Time Frame: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of maltol glucuronide Cmax from PK samples collected on Day 10

  5. Area Under The Curve [AUC] of maltol on Day 1 [ Time Frame: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of maltol AUC from PK samples collected on Day 1

  6. Area Under The Curve [AUC] of maltol glucuronide on Day 1 [ Time Frame: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of maltol glucuronide AUC from PK samples collected on Day 1

  7. Area Under The Curve [AUC] of maltol on Day 10 [ Time Frame: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of maltol AUC from PK samples collected on Day 10

  8. Area Under The Curve [AUC] of maltol glucuronide on Day 10 [ Time Frame: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of maltol AUC from PK samples collected on Day 10

  9. Average Plasma Concentration [Cave(0-6h)] of maltol on Day 1 [ Time Frame: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of maltol Cave(0-6h) from PK samples collected on Day 1

  10. Average Plasma Concentration [Cave(0-6h)] of maltol on Day 10 [ Time Frame: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of maltol Cave(0-6h) from PK samples collected on Day 10

  11. Average Plasma Concentration [Cave(0-6h)] of maltol glucuronide on Day 1 [ Time Frame: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of maltol glucuronide Cave(0-6h) from PK samples collected on Day 1

  12. Average Plasma Concentration [Cave(0-6h)] of maltol glucuronide on Day 10 [ Time Frame: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of maltol glucuronide Cave(0-6h) from PK samples collected on Day 10

  13. Time of Maximum Plasma Concentration [Tmax] of maltol on Day 1 [ Time Frame: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of maltol Tmax from PK samples collected on Day 1

  14. Time of Maximum Plasma Concentration [Tmax] of maltol on Day 10 [ Time Frame: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of maltol Tmax from PK samples collected on Day 10

  15. Time of Maximum Plasma Concentration [Tmax] of maltol glucuronide on Day 1 [ Time Frame: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of maltol glucuronide Tmax from PK samples collected on Day 1

  16. Time of Maximum Plasma Concentration [Tmax] of maltol glucuronide on Day 10 [ Time Frame: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of maltol glucuronide Tmax from PK samples collected on Day 10

  17. Half Life [t1/2] of maltol on Day 1 [ Time Frame: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of maltol t1/2 from PK samples collected on Day 1

  18. Half Life [t1/2] of maltol on Day 10 [ Time Frame: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of maltol t1/2 from PK samples collected on Day 10

  19. Half Life [t1/2] of maltol glucuronide on Day 1 [ Time Frame: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of maltol glucuronide t1/2 from PK samples collected on Day 1

  20. Half Life [t1/2] of maltol glucuronide on Day 10 [ Time Frame: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of maltol glucuronide t1/2 from PK samples collected on Day 10

  21. Ratio of Maximum Plasma Concentration [Cmax] of maltol on Day 10/Day 1 [ Time Frame: Day 1 and Day 10, pre-dose and up to 6 hours post-dose ]
    Descriptive statistics of ratio maltol Cmax Day 10/Day 10 from PK samples collected on Day 1 and Day 10

  22. Ratio of Maximum Plasma Concentration [Cmax] of maltol glucuronide on Day 10/Day 1 [ Time Frame: Day 1 and Day 10, pre-dose and up to 6 hours post-dose ]
    Descriptive statistics of ratio maltol glucuronide Cmax Day 10/Day 10 from PK samples collected on Day 1 and Day 10

  23. Ratio of Area Under The Curve [AUC] of maltol on Day 10/Day 1 [ Time Frame: Day 1 and Day 10, pre-dose and up to 6 hours post-dose ]
    Descriptive statistics of ratio maltol AUC Day 10/Day 10 from PK samples collected on Day 1 and Day 10

  24. Ratio of Area Under The Curve [AUC] of maltol glucuronide on Day 10/Day 1 [ Time Frame: Day 1 and Day 10, pre-dose and up to 6 hours post-dose ]
    Descriptive statistics of ratio maltol glucuronide AUC Day 10/Day 10 from PK samples collected on Day 1 and Day 10

  25. Ratio of Average Plasma Concentration [Cave(0-6h)] of maltol on Day 10/Day 1 [ Time Frame: Day 1 and Day 10, pre-dose and up to 6 hours post-dose ]
    Descriptive statistics of ratio maltol Cave(0-6h) Day 10/Day 10 from PK samples collected on Day 1 and Day 10

  26. Ratio of Average Plasma Concentration [Cave(0-6h)] of maltol glucuronide on Day 10/Day 1 [ Time Frame: Day 1 and Day 10, pre-dose and up to 6 hours post-dose ]
    Descriptive statistics of ratio maltol glucuronide Cave(0-6h) Day 10/Day 10 from PK samples collected on Day 1 and Day 10

  27. Apparent Systemic Clearance (CL/F) of maltol on Day 1 [ Time Frame: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of maltol CL/F from PK samples collected on Day 1

  28. Apparent Systemic Clearance (CL/F) of maltol on Day 10 [ Time Frame: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of maltol CL/F from PK samples collected on Day 10

  29. Apparent Systemic Clearance (CL/F) of maltol glucuronide on Day 1 [ Time Frame: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of maltol glucuronide CL/F from PK samples collected on Day 1

  30. Apparent Systemic Clearance (CL/F) of maltol glucuronide on Day 10 [ Time Frame: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of maltol glucuronide CL/F from PK samples collected on Day 10

  31. Apparent Volume of Distribution (V/F) of maltol on Day 1 [ Time Frame: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of maltol V/F from PK samples collected on Day 1

  32. Apparent Volume of Distribution (V/F) of maltol on Day 10 [ Time Frame: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of maltol V/F from PK samples collected on Day 10

  33. Apparent Volume of Distribution (V/F) of maltol glucuronide on Day 1 [ Time Frame: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of maltol glucuronide V/F from PK samples collected on Day 1

  34. Apparent Volume of Distribution (V/F) of maltol glucuronide on Day 10 [ Time Frame: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of maltol glucuronide V/F from PK samples collected on Day 10

  35. Average Serum Concentration [Cave(0-6h)] of iron on Day 1 [ Time Frame: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of iron Cave(0-6h) from PK samples collected on Day 1

  36. Average Serum Concentration [Cave(0-6h)] of iron on Day 10 [ Time Frame: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of iron Cave(0-6h) from PK samples collected on Day 10

  37. Average Serum Concentration [Cave(0-6h)] of transferrin saturation (TSAT) on Day 1 [ Time Frame: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of TSAT Cave(0-6h) from PK samples collected on Day 1

  38. Average Serum Concentration [Cave(0-6h)] of transferrin saturation (TSAT) on Day 10 [ Time Frame: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of TSAT Cave(0-6h) from PK samples collected on Day 10

  39. Change from Pre-Dose (Ctrough) to Maximum Post-Dose (Cmax) in serum iron on Day 1 [ Time Frame: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of change in serum iron [Ctrough to Cmax] from PK samples collected on Day 1

  40. Change from Pre-Dose (Ctrough) to Maximum Post-Dose (Cmax) in serum iron on Day 10 [ Time Frame: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of change in serum iron [Ctrough to Cmax] from PK samples collected on Day 10

  41. Change from Pre-Dose (Ctrough) to Maximum Post-Dose (Cmax) in transferrin saturation (TSAT) on Day 1 [ Time Frame: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of change in TSAT [Ctrough to Cmax] from PK samples collected on Day 1

  42. Change from Pre-Dose (Ctrough) to Maximum Post-Dose (Cmax) in transferrin saturation (TSAT) on Day 10 [ Time Frame: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of change in TSAT [Ctrough to Cmax] from PK samples collected on Day 10

  43. Pre-dose adjusted Incremental Area Under the Curve [AUC(0-6h)] of serum iron on Day 1 [ Time Frame: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of pre-dose adjusted incremental AUC(0-6h) of serum iron from PK samples collected on Day 1

  44. Pre-dose adjusted Incremental Area Under the Curve [AUC(0-6h)] of serum iron on Day 10 [ Time Frame: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of pre-dose adjusted incremental AUC(0-6h) of serum iron from PK samples collected on Day 10

  45. Pre-dose adjusted Incremental Area Under the Curve [AUC(0-6h)] of transferrin saturation (TSAT) on Day 1 [ Time Frame: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of pre-dose adjusted incremental AUC(0-6h) of TSAT from PK samples collected on Day 1

  46. Pre-dose adjusted Incremental Area Under the Curve [AUC(0-6h)] of transferrin saturation (TSAT) on Day 10 [ Time Frame: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of pre-dose adjusted incremental AUC(0-6h) of TSAT from PK samples collected on Day 10

  47. Percentage change in Pre-dose adjusted Incremental Area Under the Curve [AUC(0-6h)] of transferrin saturation (TSAT) from Day 1 to Day 10 [ Time Frame: Day 1 and Day 10, pre-dose and up to 6 hours post-dose ]
    Descriptive statistics for change in pre-dose adjusted incremental AUC(0-6h) of TSAT from Day 1 to Day 10.

  48. Percentage change in Pre-dose adjusted Incremental Area Under the Curve [AUC(0-6h)] of serum iron from Day 1 to Day 10 [ Time Frame: Day 1 and Day 10, pre-dose and up to 6 hours post-dose ]
    Descriptive statistics for change in pre-dose adjusted incremental AUC(0-6h) of serum iron from Day 1 to Day 10.

  49. Apparent Systemic Clearance (CL/F) of iron on Day 1 [ Time Frame: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of serum iron CL/F from PK samples collected on Day 1

  50. Apparent Systemic Clearance (CL/F) of iron on Day 10 [ Time Frame: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of serum iron CL/F from PK samples collected on Day 10

  51. Apparent Systemic Clearance (CL/F) of transferrin saturation (TSAT) on Day 1 [ Time Frame: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of serum TSAT CL/F from PK samples collected on Day 1

  52. Apparent Systemic Clearance (CL/F) of transferrin saturation (TSAT) on Day 10 [ Time Frame: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of serum TSAT CL/F from PK samples collected on Day 10

  53. Apparent Volume of Distribution (V/F) of iron on Day 1 [ Time Frame: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of iron V/F from PK samples collected on Day 1

  54. Apparent Volume of Distribution (V/F) of iron on Day 10 [ Time Frame: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of iron V/F from PK samples collected on Day 10

  55. Apparent Volume of Distribution (V/F) of transferrin saturation (TSAT) on Day 1 [ Time Frame: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of TSAT V/F from PK samples collected on Day 1

  56. Apparent Volume of Distribution (V/F) of transferrin saturation (TSAT) on Day 10 [ Time Frame: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose ]
    Descriptive statistics and population PK analysis of TSAT V/F from PK samples collected on Day 10


Secondary Outcome Measures :
  1. Serum Concentrations of Transferrin on Day 1 and Day 10 [ Time Frame: Day 1 and Day 10, pre-dose and up to 6 hours post-dose ]
    Descriptive statistics for serum Transferrin from PK samples collected on Day 1 and Day 10

  2. Serum Concentrations of Ferritin on Day 1 and Day 10 [ Time Frame: Day 1 and Day 10, pre-dose and up to 6 hours post-dose ]
    Descriptive statistics for serum Ferritin from PK samples collected on Day 1 and Day 10

  3. Serum Concentrations of Total Iron Binding Capacity (TIBC) on Day 1 and Day 10 [ Time Frame: Day 1 and Day 10, pre-dose and up to 6 hours post-dose ]
    Descriptive statistics for serum TIBC from PK samples collected on Day 1 and Day 10

  4. Serum Concentrations of Unsaturated Iron Binding Capacity (UIBC) on Day 1 and Day 10 [ Time Frame: Day 1 and Day 10, pre-dose and up to 6 hours post-dose ]
    Descriptive statistics for serum UIBC from PK samples collected on Day 1 and Day 10

  5. Serum Concentrations of Non-Transferrin Bound Iron (NTBI) on Day 1 and Day 10 [ Time Frame: Day 1 and Day 10, pre-dose and up to 6 hours post-dose ]
    Descriptive statistics for serum NTBI from PK samples collected on Day 1 and Day 10

  6. Haemoglobin Concentration at Screening and on Day 10 [ Time Frame: Screening and Day 10 (1-4 hours post-dose) ]
    Descriptive statistics for haemoglobin concentration from blood samples collected at Screening and on Day 10

  7. Absolute Reticulocyte Count at Screening and on Day 10 [ Time Frame: Screening and Day 10 (1-4 hours post-dose) ]
    Descriptive statistics for absolute reticulocyte count from blood samples collected at Screening and on Day 10

  8. Treatment-emergent Adverse Events (AEs) [ Time Frame: From first dose of Ferric Maltol on Day 1 through study completion, on average 4 weeks ]
    Descriptive summary of incidence and causal relationship of treatment-emergent adverse events according to MedDRA preferred term (PT) and system organ class (SOC)

  9. Treatment-emergent Serious Adverse Events (SAEs) [ Time Frame: From first dose of Ferric Maltol on Day 1 through study completion, on average 4 weeks ]
    Descriptive summary of incidence and causal relationship of treatment-emergent serious adverse events according to MedDRA preferred term (PT) and system organ class (SOC)

  10. Treatment-emergent Adverse Events (AEs) leading to premature discontinuation of study drug/PK assessments [ Time Frame: From first dose of Ferric Maltol on Day 1 through study completion, on average 4 weeks ]
    Descriptive summary of incidence and causal relationship of treatment-emergent adverse events leading to discontinuation of study drug/PK assessments according to MedDRA preferred term (PT) and system organ class (SOC)

  11. Routine Clinical Laboratory Safety Blood Results at Screening and Day 10 [ Time Frame: Screening and Day 10 (1-4 hours post-dose) ]
    Descriptive statistics for routine clinical laboratory safety blood parameters from samples collected at Screening and on Day 10

  12. Changes in Vital Signs from Screening to Post-Study Follow-up [ Time Frame: Screening, Day 1, Day 10 and Post-Study Follow-up visit, on average 4 weeks ]
    Descriptive statistics for changes in blood pressure, heart rate and body temperature from Screening to Post-study follow-up

  13. Changes in 12-lead ECG Parameters from Screening to Day 10 [ Time Frame: Screening and Day 10 (1-4 hours post-dose) ]
    Descriptive statistics for changes in routine ECG parameters and clinical interpretation from Screening to Day 10

  14. Concomitant medications [ Time Frame: Screening, Day 1, Day 10 and Post-Study Follow-up visit, on average 4 weeks ]
    Descriptive summary of prior and concomitant medications usage/incidence according to ATC code and WHO drug preferred term



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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 the IEC approved Assent form.
  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, such as implants, injectables, some intrauterine contraceptive devices (IUDs), complete sexual abstinence, a vasectomized partner and oral contraceptive medications.

Exclusion Criteria:

  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.
  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 included at the Investigator's discretion.
  14. Scheduled or expected hospitalisation 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 objectives 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03181451


Locations
United Kingdom
Leicester Royal Infirmary
Leicester, United Kingdom, LE1 5WW
Alder Hey Children's NHS Foundation Trust
Liverpool, United Kingdom, L14 5AB
University College London Hospitals NHS Foundation Trust
London, United Kingdom, NW1 2PG
King's College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
Great Ormond Street Hospital
London, United Kingdom, WC1N 3JH
Royal Manchester Children`s Hospital
Manchester, United Kingdom, M13 9WL
Nottingham University Hospital
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
Shield Therapeutics
Medpace, Inc.
Investigators
Study Director: Mark Sampson, MBChB Shield Therapeutics

Responsible Party: Shield Therapeutics
ClinicalTrials.gov Identifier: NCT03181451     History of Changes
Other Study ID Numbers: ST10-01-103
First Posted: June 8, 2017    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Ferric Compounds
Hematinics