Overview
Safety and Efficacy Study of Oral Ferric Iron To Treat Iron Deficiency Anaemia in Quiescent Ulcerative Colitis (AEGIS-1)
Status:
Completed
Completed
Trial end date:
2014-10-01
2014-10-01
Target enrollment:
0
0
Participant gender:
All
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 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Iron Therapeutics
Shield TherapeuticsTreatments:
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