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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00537186
Other study ID # P-CHF-01
Secondary ID EudraCT No.: 200
Status Completed
Phase Phase 3
First received September 27, 2007
Last updated October 7, 2008
Start date June 2007
Est. completion date July 2008

Study information

Verified date October 2008
Source Pharmacosmos A/S
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: Ethics CommitteeSweden: Medical Products AgencySweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial Summary

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.


Description:

Iron dextrans have been marketed for more than 50 years and the compiled preclinical and clinical experience with iron dextrans in general is well established. Pharmacosmos A/S already markets the iron dextran CosmoFer® worldwide, except in the US where the product is named INFeD®. A new iron oligosaccharide has been manufactured by Pharmacosmos A/S and it is a further development of CosmoFer® where ferric hydroxide has been combined with low molecular weight oligosaccharides in a relatively strong complex. This iron carbohydrate complex builds on the well established efficacy and safety profile of existing iron dextran but with a significantly reduced anaphylactic potential.

In order to ensure that iron oligosaccharide will not lead to unexpected adverse events the existing clinical information on iron dextrans in general needs to be supplied with clinical safety data from a limited number of relevant patients exposed to iron oligosaccharide in open label non-comparator studies.

The primary objective of the present study is to obtain safety reassurance with the use of iron oligosaccharide given either as repeated IV boluses or as total dose infusion for the correction of anaemia in patients with congestive heart failure in order to ensure that iron oligosaccharide will not lead to unexpected adverse events in these patients.


Recruitment information / eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Iron oligosaccharide


Locations

Country Name City State
Denmark Roskilde University Hospital, Medicinsk afdeling Roskilde

Sponsors (1)

Lead Sponsor Collaborator
Pharmacosmos A/S

Country where clinical trial is conducted

Denmark, 

Outcome

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
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