|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00537186 |
|
Date of registration:
|
27/09/2007 |
|
Primary sponsor: |
|
|
Public title:
|
A Study of Iron Oligosaccharide in CHF Patients
|
|
Scientific 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 |
|
Date of first enrolment:
|
June 2007 |
|
Target sample size:
|
20 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00537186 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Denmark
|
Sweden
| | | | | | |
|
Contacts
|
|
Name:
|
Per Hildebrandt, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Roskilde University Hospital, Medicinsk afdeling |
| | |
|
Key inclusion & exclusion criteria
|
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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Heart Failure, Congestive
|
|
Intervention(s)
|
|
Drug: Iron oligosaccharide
|
|
Primary Outcome(s)
|
|
Adverse events (AE) (Number and type of AE)
[Time Frame: Eight weeks after enrollment]
|
|
Clinical laboratory tests (biochemistry, haematology)
[Time Frame: At every visit]
|
|
Physical examination
[Time Frame: At screening visit and at end of study]
|
|
Serious adverse events (SAEs)
[Time Frame: Eight weeks after enrollment]
|
|
Vital signs
[Time Frame: At every visit]
|
|
Secondary Outcome(s)
|
|
Change from baseline in haemoglobin, haematocrit, s-iron, transferrin saturation, and ferritin levels
[Time Frame: At every visit]
|
|
Secondary ID(s)
|
|
EudraCT No.: 2007-000764-25
|
|
P-CHF-01
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|