A Phase III, Open-Label Extension Trial of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia, evaluating the Safety and Efficacy of Ferumoxytol
- Conditions
- Iron deficiency anemia (IDA)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]MedDRA version: 14.0Level: LLTClassification code 10022976Term: Iron deficiency anemia secondary to inadequate dietary iron intakeSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 14.0Level: LLTClassification code 10022975Term: Iron deficiency anemia secondary to blood loss (chronic)System Organ Class: 10005329 - Blood and lymphatic system disorders
- Registration Number
- EUCTR2011-001866-17-PL
- Lead Sponsor
- AMAG Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 634
1.Subjects who met all inclusion/exclusion criteria for AMAG-FER-IDA-301, received any study drug, and completed the Week 5 visit within the past 14 days
2.Female subjects of childbearing potential who are sexually active must be on an effective method of birth control and agree to remain on birth control until completion of participation in the study
3.Subject is capable of understanding and complying with the protocol requirements and available for the duration of the study
4.Subject has been informed of the investigational nature of this study and has given voluntary written informed consent and, if applicable, Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional, local, and national personal health data protection guidelines
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 640
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 160
1.Experienced a serious adverse event (SAE) related to ferumoxytol in study AMAG-FER-IDA-301
2.Female subjects who are pregnant, intend to become pregnant, are breastfeeding, or have a positive serum/urine pregnancy test
3.Received IV or oral iron since completion of AMAG-FER-IDA-301
4.Major surgery or invasive intervention (with the exception of uncomplicated diagnostic colonoscopy, endoscopy, and tubal ligation)during participation in or since completion of AMAG FER IDA-301
5.Active clinically significant infection or acute serious medical illness (with the exception of cancer) requiring treatment or intervention
6.Received another investigational agent during participation in study AMAG-FER IDA 301 or prior to enrollment in this study
7.Any other clinically significant medical disease or condition (eg, uncontrolled hypertension) or subject responsibility that, in the Investigator’s opinion, may interfere with a subject’s (and/or guardian’s) ability to give informed consent, adhere to the protocol, interfere with assessment of the investigational product, or serve as a contraindication to the subject’s participation in the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the safety and efficacy of ferumoxytol for the episodic treatment of iron deficiency anemia (IDA) over a 6-month period ;Secondary Objective: Not Applicable;Primary end point(s): Mean change in hemoglobin from treatment period (TP) Baseline (defined as the hemoglobin level immediately prior to each ferumoxytol treatment course) to TP Week 5 following the first course of ferumoxytol ;Timepoint(s) of evaluation of this end point: Week 5
- Secondary Outcome Measures
Name Time Method