Red Blood Cell Precursor Formulation to Determine Increased Production

• Status: Withdrawn
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to measure the change in hemoglobin levels after the administration of an amino acid based, RBC precursor formulation.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Targeted Medical Pharma

Criteria

Inclusion Criteria:

1. M/F patients 18 to 75 years old, non-pregnant/lactating

2. Male patients with < Hemoglobin of 12.5

3. Female Patients with < Hemoglobin of 11

4. Diagnosis of mild to moderate anemia by study physician

Exclusion Criteria:

1. Pregnant or unwilling to use adequate birth control for the duration of the study.

2. Unwilling or unable to sign informed consent.

3. Myocardial infarction within the last 6 months.

4. Patients currently taking an erythropoietin medication and unable to discontinue for the duration of the study.

5. GI bleed in the last 6 months.

6. Inflammatory bowel disease.

7. Chronic liver disease.