Iron Deficiency

Maintenance Treatment of Iron Deficiency in IBD Patients

NCT00810004 | PHASE 3 | INTERVENTIONAL

The aim of this study is to evaluate the treatment of iron deficiency in IBD patients.

1 Sites

245 Participants

Recruiting

18 Years to 70 Years

If interested, contact clinicaltrials@cslbehring.com for more information

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SUBMIT

State Scientific Center of Coloproctology of RosMedTekhnolgy

Moscow,Russian Federation,123423

Inclusion Criteria

Main study inclusion criteria:
For previously treated subjects, either:
* Completed a CSL-sponsored rIX-FP (CSL654) study, including study CSL654_3001 \[NCT01496274\] or study CSL654_3002 \[NCT01662531\].
Or:
* Scheduled to have a major non-emergency surgery within approximately 8 weeks from the anticipated date of receiving the first rIX-FP injection.
* Not previously completed a CSL-sponsored rIX-FP lead-in study.
* Male, 12 to 70 years of age.
* Documented severe hemophilia B (FIX activity of ≤ 2%), or confirmed at screening by the central laboratory.
* Subjects who have received FIX products (plasma-derived and / or recombinant FIX) for \> 150 exposure days (EDs), confirmed by their treating physician.
* No confirmed history of FIX inhibitor formation at screening by the central laboratory
For previously untreated subjects:
* Male, up to 18 years of age.
* Documented severe hemophilia B (FIX activity of ≤ 2%), or confirmed at screening by the central laboratory.
* Never previously been treated with FIX clotting factor products (except previous exposure to blood components).
* No confirmed history of FIX inhibitor formation
Surgery substudy inclusion criterion:
* Must require non-emergency surgery
Subcutaneous substudy inclusion criteria:
* Male, at least 18 years of age.
* Subjects currently enrolled in Study CSL654_3003
* Subjects who have received rIX-FP for ≥ 100 EDs (single-dose cohorts) or for ≥ 50 EDs (repeated-dose cohort)

Exclusion Criteria

Chronic alcohol abuse (alcohol consumption \>20 g/day).
Presence of portal hypertension with oesophageal varices. History of erythropoietin, intravenous or oral iron therapy, or blood transfusion in 12 weeks prior to screening.
Known hypersensitivity to FERINJECT®.
History of acquired iron overload.
Myelodysplastic syndrome.
Pregnancy or lactation.
Known active infection, clinically significant overt bleeding, active malignancy. Known chronic renal failure.
Surgery with relevant blood loss (defined as Hb drop \<2 g/dL) in the 3 months prior to screening or planned surgery within the following 3 months.
Chronic liver disease or increase of liver enzymes (alanine aminotransferase (\[ALT\], aspartate aminotransferase \[AST\]) \>3 times the upper limit of normal range.
Known human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
Inability to fully comprehend and/or perform study procedures in the investigator's opinion.
Participation in any other interventional study (except correction study) within 1 month prior to screening.
Body weight \<35 kg.
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.

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