Overview

Safety and Efficacy Study of Oral Ferric Iron To Treat Iron Deficiency Anaemia in Quiescent Ulcerative Colitis (AEGIS-1)

Status:
Completed
Trial end date:
2014-10-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine whether ST10-021, an oral ferric iron preparation, is safe and effective in the treatment of iron deficiency anaemia (IDA) in subjects with non-active ulcerative colitis (UC).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Iron Therapeutics
Shield Therapeutics
Treatments:
Ferric maltol
Iron
Criteria
Inclusion Criteria:

- Competency to understand and sign the IEC/IRB approved informed consent form prior to
any study mandated procedure, and willing/able to comply with study requirements

- Age ≥ 18 years

- Current diagnosis of quiescent UC as defined by SCCAI score of < 4

- Current diagnosis of IDA as defined by Hb ≥ 9.5 g/dl and <12.0 g/dl for women and ≥
9.5 g/dl and <13.0 g/dl for men; ferritin < 30 µg/l

- Prior OFP failure as defined per protocol

- If receiving protocol-allowed immunosuppressant must be on stable dose

- Females of childbearing potential must agree to use a reliable method of contraception

Exclusion Criteria:

- Anaemia due to any cause other than iron deficiency

- Intramuscular or intravenous injection or administration of depot iron preparation,
blood infusions, or erythropoietin within 3 months

- Oral iron supplementation use within 1 month

- Use of immunosuppressant with known effect of anaemia induction within 1 month

- Vitamin B12 or Folic Acid injection/infusion within 4 weeks

- Untreated Vitamin B-12 or Folic Acid deficiency

- Known hypersensitivity or allergy to ST10-021 or components of the study medication,
or contraindication for treatment with iron preparations

- Other chronic or acute inflammatory or infectious diseases

- Creatinine > 2.0 mg/dl

- AST or ALT levels ≥ 5 times the upper limit of normal

- Cardiovascular, liver, renal, hematologic, gastrointestinal, immunologic, endocrine,
metabolic, or central nervous system disease that may adversely affect the safety of
the subject and/or efficacy of the study drug or severely limit the lifespan of the
subject

- History of malignancy within the past 5 years (except in situ removal of basal cell
carcinoma)

- Significant neurologic or psychiatric symptoms resulting in disorientation, memory
impairment, or inability to report accurately that might interfere with treatment
compliance, study conduct or interpretation of the results

- Participation in another interventional clinical study within 30 days or during the
study

- Inmates of a psychiatric ward, prison, or other state institution

- Investigator or any other team member involved directly or indirectly in the conduct
of the clinical study

- Scheduled or expected hospitalization and/or surgery during the course of the study

- Females who are pregnant or lactating