Heart Failure, Congestive Clinical Trial
Official title:
A Non-Comparative Open-Label Study of Iron Oligosaccharide in CHF Patients With Iron Deficiency (Either Absolute or Functional) Anaemia and a Need for Parenteral Iron
The purpose of this study is to determine the safety profile of iron oligosaccharide in patients with congestive heart failure with a need for parenteral iron.
Status | Completed |
Enrollment | 20 |
Est. completion date | July 2008 |
Est. primary completion date | July 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Congestive heart failure - = 18 years of age at screening - Haemoglobin < 110 g/L (or 6.8 mmol/L) - Serum ferritin < 800 µgram/L - Life expectancy beyond 12 months - Willingness to participate after written informed consent Exclusion Criteria: - Non iron deficiency anaemia - Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis, haemosiderosis) - Drug hypersensitivity (i.e. previous hypersensitivity to iron dextran or iron mono- or disaccharide complexes) - Patients with a history of multiple allergies - Decompensated liver cirrhosis and hepatitis (alanine aminotransferase > 3 times normal) Acute or chronic infections Rheumatoid arthritis with symptoms or signs of active inflammation. Pregnancy and nursing. To avoid pregnancy, women have to be postmenopausal, surgically sterile, sexually inactive or practice reliable contraception Active bleeding Planned elective surgery during the study where significant blood loss is expected Participation in any other clinical trial within 3 months prior to screening |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Roskilde University Hospital, Medicinsk afdeling | Roskilde |
Lead Sponsor | Collaborator |
---|---|
Pharmacosmos A/S |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse events (AE) (Number and type of AE) | Eight weeks after enrollment | Yes | |
Primary | Serious adverse events (SAEs) | Eight weeks after enrollment | Yes | |
Primary | Physical examination | At screening visit and at end of study | Yes | |
Primary | Vital signs | At every visit | Yes | |
Primary | Clinical laboratory tests (biochemistry, haematology) | At every visit | Yes | |
Secondary | Change from baseline in haemoglobin, haematocrit, s-iron, transferrin saturation, and ferritin levels | At every visit | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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