Clinical trial NCT00354484: Safety and Efficacy of a Hematinic Agent in the Treatment of Postpartum Patients
Official title: Safety and Efficacy of a Hematinic Agent in the Treatment of Postpartum Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postpartum Anemia
Keywords: anemia
postpartum
Lead sponsor: American Regent, Inc.
Sponsor class: INDUSTRY
First posted: 2006-07-20
Enrollment: 291
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy, safety, and tolerability of VIT45 compared to the current standard of care in postpartum patients.

Detailed description: This is an open label Phase III randomized active control study of postpartum patients with anemia. Patients will be randomized to either active control or the investigational agent and followed for up to 6 weeks.

Eligibility criteria: Inclusion Criteria:

* Female Subjects able to give consent
* Post partum patients
* Baseline Hgb \< /= 10 g/dL
* Agree to practice birth control

Exclusion Criteria:

* Participation in previous clinical trial of this investigational agent
* Known hypersensitivity reaction to active control
* Significant vaginal bleeding
* History of anemia other than iron deficiency anemia
* Anticipated need for surgery during the study
* Active severe infection or malignancy
* Known positive Hepatitis B antigen of Hepatitis C viral antibody
* Known HIV antibodies
* Received an investigational drug within 30 days of screening
* Alcohol abuse within past 6 months
* Hemochromatosis or other iron storage disorders
* Significant cardiovascular disease
* Any laboratory abnormality, medical condition or severe psychiatric disorder which in the opinion of the investigator woud put the subject's disease management at risk or may result in the subject being able to comply with the study requirements

Primary outcomes:
measure: Number of Patients Classified as a 'Clinical Success'. Clinical Success Was Defined as the Number of Subjects With an Increase in Hemoglobin of >12 g/dL
timeFrame: anytime between baseline and end of study or time to intervention
measure: Reported Adverse Events
timeFrame: anytime between baseline and end of study or time to intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Norristown
country: United States
facility: Luitpold Pharmaceuticals
state: Pennsylvania
Study officials:
References:
citation: Van Wyck DB, Martens MG, Seid MH, Baker JB, Mangione A. Intravenous ferric carboxymaltose compared with oral iron in the treatment of postpartum anemia: a randomized controlled trial. Obstet Gynecol. 2007 Aug;110(2 Pt 1):267-78. doi: 10.1097/01.AOG.0000275286.03283.18.
citation: Seid MH, Rogers R, Dinh Q. Treating Postpartum Anemia with Intravenous Ferric Carboxymaltose: A Randomized Controlled Study. Southern Medical Association Scientific Assembly 2008.
citation: Seid MH, Derman RJ, Baker JB, Banach W, Goldberg C, Rogers R. Ferric carboxymaltose injection in the treatment of postpartum iron deficiency anemia: a randomized controlled clinical trial. Am J Obstet Gynecol. 2008 Oct;199(4):435.e1-7. doi: 10.1016/j.ajog.2008.07.046.
citation: Seid MH, Rogers R, Dinh Q. The Safety and Tolerability of Ferric Carboxymaltose in Treating Postpartum Women with Iron Dediciency Anemia. American College of Obstetrics & Gynecology District Meeting 2007.
citation: Seid MH, Mangione A, Valaoras TG, Anthony LB, Barish CF. Safety Profile of Ferric Carboxymaltose, a New High Dose Intravenous Iron in Patients with Iron Deficiency Anemia. Society for the Advancement of Blood Managment 6th Annual Meeting 2007.
citation: Goodnough LT. Treating Postpartum Anemia with Intravenous Ferric Carboxymaltose: a Randomized Controlled Study. Nordic Conference of Obstetrics & Gynecology 2008.