Red Blood Cell Precursor Formulation to Determine Increased Production

Anemia Clinical Trial

— RBCPF  

Official title:

An Open-Label, Pilot Study of a Red Blood Cell Precursor Formulation to Determine Increased Production in Subjects With Mild to Moderate Anemia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01701531
• Other study ID #: RBC100312
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: October 3, 2012
• Last updated: May 4, 2016
• Start date: October 2012
• Est. completion date: May 2014

Study information

• Verified date: May 2016
• Source: Targeted Medical Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Medical foods are a distinct FDA regulatory category different from single molecule chemical pharmaceuticals, and from dietary supplements. The FDA has regulated amino acid preparations as drugs since the 1940s as they can elicit pharmacologic effects similar to conventional single molecule pharmaceuticals. The best known amino acid preparations are used to treat conditions such as maple syrup disease and phenylketonuria (PKU). An official definition and categorization of medical foods was made in 1988 as part of the Orphan Drug Act. Medical foods are regulated similarly to drugs except they do not require pre-approval because all ingredients are found on the FDA's generally recognized as safe (GRAS) (Sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act) list and claims are confined to the nutritional management of a specific disease. Medical food claims must be supported by recognized scientific data as determined by medical evaluation. A GRAS substance is distinguished from a food additive on the basis of the common knowledge about the safety of the substance for its intended use. The standard for an ingredient to achieve GRAS status requires not only technical demonstration of non-toxicity and safety, but also general recognition of safety through widespread usage and agreement of that safety by experts in the field. Many ingredients have been determined by the FDA to be GRAS, and are listed as such by regulation, in Volume 21 Code of Federal Regulations (CFR) Sections 182, 184, and 186.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• RBCPF

Locations

Country	Name	City	State
United States	Lawrence May, MD, Inc.	Tarzana	California

Sponsors (1)

Lead Sponsor	Collaborator
Targeted Medical Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hemoglobin level 2 hours after administration of the first dose.	Subjects will have blood drawn at baseline and 2 hours after the administration of the treatment intervention. Then again, after 7 days.	Baseline, 2 hours and 7 days	No
Secondary	CBC w/ differential		Baseline, 2 hours and 7 days	Yes
Secondary	Erythropoietin level		Baseline, 2 hours and 7 days	No
Secondary	Reticulocytes		Baseline, 2 hours and 7 days	No
Secondary	Iron levels		Baseline, 2 hours and 7 days	No
Secondary	Ferritin		Baseline, 2 hours and 7 days	No
Secondary	IGG		Baseline, 2 hours and 7 days	No
Secondary	B12		Baseline, 2 hours and 7 days	No