Red Blood Cell Precursor Formulation to Determine Increased Production (RBCPF)

This study is currently recruiting participants.
Verified October 2012 by Targeted Medical Pharma
Sponsor:
Information provided by (Responsible Party):
Targeted Medical Pharma
ClinicalTrials.gov Identifier:
NCT01701531
First received: October 3, 2012
Last updated: October 4, 2012
Last verified: October 2012
  Purpose

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


Condition Intervention Phase
Anemia
Drug: RBCPF
Phase 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Targeted Medical Pharma:

Primary Outcome Measures:
  • Change in hemoglobin level 2 hours after administration of the first dose. [ Time Frame: Baseline, 2 hours and 7 days ] [ Designated as safety issue: No ]
    Subjects will have blood drawn at baseline and 2 hours after the administration of the treatment intervention. Then again, after 7 days.


Secondary Outcome Measures:
  • CBC w/ differential [ Time Frame: Baseline, 2 hours and 7 days ] [ Designated as safety issue: Yes ]
  • Erythropoietin level [ Time Frame: Baseline, 2 hours and 7 days ] [ Designated as safety issue: No ]
  • Reticulocytes [ Time Frame: Baseline, 2 hours and 7 days ] [ Designated as safety issue: No ]
  • Iron levels [ Time Frame: Baseline, 2 hours and 7 days ] [ Designated as safety issue: No ]
  • Ferritin [ Time Frame: Baseline, 2 hours and 7 days ] [ Designated as safety issue: No ]
  • IGG [ Time Frame: Baseline, 2 hours and 7 days ] [ Designated as safety issue: No ]
  • B12 [ Time Frame: Baseline, 2 hours and 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: October 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RBCPF
Treatment intervention arm
Drug: RBCPF
Other Name: Red blood cell precursor formulation

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01701531

Contacts
Contact: Stephanie Pavlik, CRA 3104749809 ext 113 spavlik@ptlcentral.com

Locations
United States, California
Lawrence May, MD, Inc. Recruiting
Tarzana, California, United States, 91356
Contact: Lawrence May, MD    818-344-6496    spavlik@ptlcentral.com   
Sponsors and Collaborators
Targeted Medical Pharma
Investigators
Principal Investigator: Lawrence May, MD Lawrence May MD, Inc
  More Information

No publications provided

Responsible Party: Targeted Medical Pharma
ClinicalTrials.gov Identifier: NCT01701531     History of Changes
Other Study ID Numbers: RBC100312
Study First Received: October 3, 2012
Last Updated: October 4, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on April 23, 2014