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Health Condition(s) or Problem
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Iron Deficiency Anaemia; Inflammatory Bowel Disease; Ulcerative Colitis
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Lay Summary
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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).
(from ClinicalTrials.gov)
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Who can enter the trial
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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 = 10.0 g/dl and <12.0 g/dl for women and =
10.0 g/dl and <13.0 g/dl for men; ferritin < 30 µg/l; TSAT < 16%; and MCV < 80 µm3
- 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 2 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
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Who cannot enter the trial
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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 = 10.0 g/dl and <12.0 g/dl for women and =
10.0 g/dl and <13.0 g/dl for men; ferritin < 30 µg/l; TSAT < 16%; and MCV < 80 µm3
- 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 2 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
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What will happen
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Drug; ST10-021; 30 mg capsules to be taken orally twice a day for 12 weeks; ST10-021; Ferric Trimaltol; Drug; Placebo Comparator; Matching sugar pill to be taken orally twice a day for 12 weeks; Sugar pill
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Primary aim
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Change in Hb concentration from baseline to Week 12
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Secondary Aim
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Number of subjects that achieve an increase in Hb concentration by =1 g/dl over the trial period; up to Week 12; No; Number of subjects that achieve an increase in Hb concentration by =2 g/dl over the trial period; up to Week 12; No; Number of subjects that achieve Hb concentration within normal range over the trial period; up to Week 12; No; Change in Hb concentration from baseline to Week 8; Week 8; Yes; Change in Hb concentration from baseline to Week 4 (early response); Week 4; Yes; Change in quality of life (QOL) based upon changes of the SF-36 QOL questionnaire from baseline to Week 12; Week 12; No; Treatment emergent Adverse Events, Serious Adverse Events, and clinically relevant laboratory abnormalities; up to Week 14; Yes; Change from baseline to Week 12 of SCCAI; Week 12; Yes; The Simple Clinical Colitis Activity Index (SCCAI) is a measure of ulcerative colitis (UC) disease activity; Change from baseline to Week 12 in vital signs: blood pressure, heart rate and body weight; Week 12; Yes; Adverse events leading to premature discontinuation of study drug; up to Week 14; Yes
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Recruiting
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Nation
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England
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Location
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Worthing
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