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Trial record 19 of 36 for:    pharmacosmos

A Randomized, Double-blind, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Against Placebo

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ClinicalTrials.gov Identifier: NCT02172001
Recruitment Status : Withdrawn (Study design not adequate)
First Posted : June 24, 2014
Last Update Posted : September 28, 2016
Sponsor:
Information provided by (Responsible Party):
Pharmacosmos A/S

Tracking Information
First Submitted Date  ICMJE June 21, 2014
First Posted Date  ICMJE June 24, 2014
Last Update Posted Date September 28, 2016
Study Start Date  ICMJE Not Provided
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2014)
Proportion of subjects with an Hb increase of ≥ 2 g/dL from baseline at any time from week 1 to week 5 [ Time Frame: Week 1 to 5 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02172001 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2014)
Time to Hb ≥ 2 g/dL [ Time Frame: Week 1 to 5 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized, Double-blind, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Against Placebo
Official Title  ICMJE A Phase III, Randomised, Double-blind, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Against Placebo in Subjects With Iron Deficiency Anaemia and Who Are Intol-erant or Unresponsive to Oral Iron Therapy
Brief Summary The primary objective of the study is to evaluate and compare the effect of iron isomaltoside 1000 to placebo in its ability to increase haemoglobin (Hb) in subjects with IDA when oral iron preparations are ineffective or cannot be used.
Detailed Description

IDA is highly prevalent in subjects and can have a substantial medical and quality of life (QoL) burden on the subjects and the treatment of these subjects includes replenishing lost iron. Oral iron administration is often used in the clinical practice at many clinics; however, oral iron may not be tolerated by all subjects. Hence, there is a need for an alternative iron treatment in subjects, who do not tolerate oral iron.

This study is planned to compare the efficacy and safety of iron isomaltoside 1000 with placebo in subjects with IDA and who are intolerant or unresponsive to oral iron therapy..

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Iron Deficiency Anemia
Intervention  ICMJE
  • Drug: Iron isomaltoside 1000
  • Drug: Natrium Chloride 0,9%
    100 ml or 5 ml
Study Arms  ICMJE
  • Experimental: Iron isomaltoside 1000
    Iron isomaltoside 1000. Dose: 1000 mg, 1500 mg or 2000 mg
    Intervention: Drug: Iron isomaltoside 1000
  • Placebo Comparator: Placebo (NaCl 0,9%)
    Sodium Chloride. Dose: 100 ml or 5 ml
    Intervention: Drug: Natrium Chloride 0,9%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 28, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: June 23, 2014)
200
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Men or women ≥ 18 years having IDA caused by different aetiologies* such as ab-normal uterine bleeding, gastrointestinal diseases (e.g. inflammatory bowel disease), cancer, preoperative anaemia (e.g. orthopaedic surgery), and other conditions leading to IDA and with a documented history of intolerance or unresponsiveness to oral iron therapy** for at least one month*** prior to study enrolment
  2. Hb < 11 g/dL
  3. TSAT < 20 %
  4. S-ferritin < 100 ng/mL
  5. Willingness to participate and signing the informed consent form (ICF)

Exclusion Criteria:

  1. Hb < 6 g/dL
  2. Anaemia predominantly caused by factors other than IDA (e.g. anaemia with untreat-ed vitamin B12 or folate deficiency, haemolytic anaemia)
  3. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and hae-mosiderosis)
  4. Decompensated liver cirrhosis or active hepatitis (ALAT > 3 times upper limit of normal)
  5. Active acute or chronic infections (assessed by clinical judgement supplied with white blood cells (WBC) and C-reactive protein (CRP))
  6. Body weight < 50 kg
  7. Pregnant or nursing women. In order to avoid pregnancy, women of childbearing po-tential have to use adequate contraception (e.g. intrauterine devices, hormonal contra-ceptives, or double barrier method) during the whole study period and 7 days after the last dosing
  8. History of multiple allergies
  9. Known hypersensitivity to parenteral iron or any excipients in the investigational drug products
  10. Erythropoietin treatment within 8 weeks prior to the screening visit
  11. Other intravenous (IV) iron treatment or blood transfusion within 4 weeks prior to the screening visit
  12. Participation in any other interventional clinical study within 3 months prior to the screening
  13. Any other medical condition that, in the opinion of Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study, e.g. uncontrolled hypertension, unstable ischemic heart disease, or uncontrolled diabetes mellitus
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02172001
Other Study ID Numbers  ICMJE P-Monofer-IDA-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pharmacosmos A/S
Study Sponsor  ICMJE Pharmacosmos A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Pharmacosmos A/S
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP