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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

Tracking Information
First Submitted Date July 11, 2013
First Posted Date July 16, 2013
Last Update Posted Date March 2, 2016
Study Start Date August 2013
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 11, 2013)
Time to relapse of iron deficiency anemia [ Time Frame: From screening until 12 months ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01900197 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 18, 2015)
Number of ADRs [ Time Frame: From screening until 12 months ]
Original Secondary Outcome Measures
 (submitted: July 11, 2013)
Number of AE's [ Time Frame: From screening until 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Time to Relapse of Iron Deficiency Anemia After Standard Treatment With a New Intravenous Iron (Monofer®)
Official Title A Non-intervention Trial of the Time to Relapse of Iron Deficiency Anemia After Standard Treatment With a New Intravenous Iron (Monofer®)
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.
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
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
Condition Iron Deficiency Anemia
Intervention Drug: 10% Iron Isomaltoside 1000
Administered according to local routines and product labeling in doses at the doctors discretion
Other Name: Monofer®
Study Groups/Cohorts 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
Intervention: Drug: 10% Iron Isomaltoside 1000
Publications * Frigstad SO, Haaber A, Bajor A, Fallingborg J, Hammarlund P, Bonderup OK, Blom H, Rannem T, Hellström PM. The NIMO Scandinavian Study: A Prospective Observational Study of Iron Isomaltoside Treatment in Patients with Iron Deficiency. Gastroenterol Res Pract. 2017;2017:4585164. doi: 10.1155/2017/4585164. Epub 2017 Oct 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 18, 2015)
391
Original Estimated Enrollment
 (submitted: July 11, 2013)
300
Actual Study Completion Date November 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT01900197
Other Study ID Numbers Monofer®-NIS-14
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pharmacosmos A/S
Study Sponsor Pharmacosmos A/S
Collaborators BioStata
Investigators Not Provided
PRS Account Pharmacosmos A/S
Verification Date February 2016