Status:
TERMINATED
Ferinject® in Patient With Thrombocytosis Secondary to Inflammatory Bowel Disease (IBD)
Lead Sponsor:
Vifor Pharma
Conditions:
Thrombocytosis
Iron-Deficiency Anemia
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
The aim of this study is to show the benefits for patients, with a high platelet count, iron deficiency and IBD, receiving intravenous iron therapy.
Detailed Description
For the first time a platelet abnormality in IBD was reported in 1968, with a description of an increased platelet count in patients having an exacerbation of clinical activity 1. Since then it has be...
Eligibility Criteria
Inclusion
- Male or female, inpatient or outpatient, aged at least 18 years and not more than 60 years.
- Have a platelet count \>450G/l
- Transferrin saturation (TfS) \<20% or ferritin \< 100µg/l
- Previously diagnosed inflammatory bowel disease (Crohn's disease or ulcerative colitis)
- Females of child-bearing potential must have a negative urine pregnancy test at screening and be practicing a highly effective method of birth control during the study and for up to 1 month after the last dose of the study medication. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. Non-childbearing potential includes being surgically sterilized at least 6 months prior to the study or postmenopausal, defined as amenorrhoea for at least 12 months.
- Demonstrate the ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to undergo the required assessments.
Exclusion
- CDAI \>220, CAI\>6
- Significant anemia (hemoglobin \<10.5 g/dl), or anaemia not caused by iron deficiency (e.g. anaemia due to cancer or infection)
- Blood transfusions or iron therapy during the previous 4 weeks, or erythropoietin treatment within the 8 weeks prior to enrollment.
- Concomitant therapy with prednisolone above 20mg/d, 6-mercaptopurine, infliximab or azathioprine must have been initiated at least 4 months prior to study and the dose must be stable for at least 8 weeks. Other drugs with known effects on megakaryopoiesis (e.g. interferon-alpha).
- Severe concomitant disease or need for surgery within 8 weeks
- Hemochromatosis or other iron-storage disorders (e.g. thalassemia, siderosis, lead poisoning anaemia, porphyria cutanea tarda)
- Treatment with an investigational drug within the 30 days prior to enrollment
- Active severe infection or malignancy other than carcinoma in situ of the cervix and non-melanoma skin cancer.
- Bone Marrow Disease (MDS, thalassemia, etc)
- Active or chronic liver or kidney disease. Serum albumin \<25 g/L or serum creatinine \>20 mg/L
- Significant cardiovascular disease, including myocardial infarction within 12 months prior to study inclusion, congestive heart failure NYHA (New York Heart Association) grade III or IV, or poorly controlled hypertension according to the judgment of the investigator. Known hypersensitivity to FERINJECT®
- Positive for HIV 1/HIV 2 antibodies (anti HIV) (HIV: human immunodeficiency virus).
- Positive for hepatitis B surface-antigen (HBsAg), hepatitis C virus antibody (anti HCV) and evidence for active hepatitis, i.e., abnormal liver function test (LFT) results.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00882414
Start Date
December 1 2006
End Date
January 1 2010
Last Update
April 8 2010
Active Locations (1)
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1
Univ. clinic for Internal Medicine
Vienna, Austria, 1090