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Trial record 21 of 36 for:    pharmacosmos

Time to Relapse of Iron Deficiency Anemia After Standard Treatment With a New Intravenous Iron (Monofer®)

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ClinicalTrials.gov Identifier: NCT01900197
Recruitment Status : Completed
First Posted : July 16, 2013
Last Update Posted : March 2, 2016
Sponsor:
Collaborator:
BioStata
Information provided by (Responsible Party):
Pharmacosmos A/S

Brief Summary:
The purpose of this study is to monitor and quality assure the efficacy and safety of Monofer® in a broad patient population when Monofer® is used according to the Monofer® label (SPC) in current practice and where standard routines are being followed.

Condition or disease Intervention/treatment
Iron Deficiency Anemia Drug: 10% Iron Isomaltoside 1000

Detailed Description:

The total duration of the study is approximately 21 months, which includes a 6 months enrolment period. The number of patient visits depends on the number of Monofer® treatment courses needed during the study period. Each patient can receive one or more treatment courses during 12 months after informed consent. The last blood test will be taken after the last Monofer® treatment course which might occur 13-15 months after Informed consent. Patients will only attend hospital visits planned as part of their standard treatment and they will receive treatment as a part of standard care and according to the doctor's discretion. Study termination will occur once the 12 months observational period has been completed for all patients and the last blood test has been collected from the last Monofer® treated patient in the study. Each treatment course can consist of one or more Monofer® administrations. For each administration of Monofer® either intravenous infusion or injection can be used. Pre- and post-treatment blood tests according to standard treatment are a part of the Monofer® treatment course.

DATA COLLECTION:

  • Clinical data management will be performed in accordance with applicable standards and data cleaning procedures.
  • The collected data will systematically be entered into an eCRF (MyEDC, Biostata). The source of information is the relevant laboratory results obtained from the patient record.
  • The data will be evaluated by the Pharmacosmos A/S Medical Affairs team.

Laboratory assessments, i.e. anemia work-up/treatment evaluation, shall be a part of local standard practice. The protocol does not accept any additional samples outside current local standard practice to be taken.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 391 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: A Non-intervention Trial of the Time to Relapse of Iron Deficiency Anemia After Standard Treatment With a New Intravenous Iron (Monofer®)
Study Start Date : August 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Group/Cohort Intervention/treatment
Iron deficiency anemia
Patients with iron deficiency anemia treated on the doctor's discretion with 10% Iron Isomaltoside 1000 (Monofer®) as standard treatment according to current practice
Drug: 10% Iron Isomaltoside 1000
Administered according to local routines and product labeling in doses at the doctors discretion
Other Name: Monofer®




Primary Outcome Measures :
  1. Time to relapse of iron deficiency anemia [ Time Frame: From screening until 12 months ]

Secondary Outcome Measures :
  1. Number of ADRs [ Time Frame: From screening until 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with iron deficiency anemia treated on the doctor's dicretion with Monofer® as standard treatment according to current practice
Criteria

Inclusion Criteria:

Patients with iron deficiency anemia treated on the doctor's discretion with Monofer® as standard treatment according to current practice

Exclusion Criteria:

None


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01900197


Locations
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Denmark
Aalborg, Denmark
Sponsors and Collaborators
Pharmacosmos A/S
BioStata

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pharmacosmos A/S
ClinicalTrials.gov Identifier: NCT01900197     History of Changes
Other Study ID Numbers: Monofer®-NIS-14
First Posted: July 16, 2013    Key Record Dates
Last Update Posted: March 2, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders
Iron
Iron isomaltoside 1000
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics