Phase 3 Completed N=289 Randomized Treatment

Safety and Efficacy of a Hematinic Agent in the Treatment of Postpartum Patients

Postpartum Anemia

Source: ClinicalTrials.gov NCT00354484 ↗

Enrolled (actual)

289

Serious AEs

2.8%

Results posted

Dec 2013

Primary outcomePrimary: 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 — 127; 98 participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	127; 98	—
PRIMARY Reported Adverse Events	—	—

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

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Data sourced from ClinicalTrials.gov (NCT00354484). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.