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

This study has been withdrawn prior to enrollment.
(Funding not received)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01701531
First Posted: October 5, 2012
Last Update Posted: May 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Targeted Medical Pharma
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]
    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 ]
  • Erythropoietin level [ Time Frame: Baseline, 2 hours and 7 days ]
  • Reticulocytes [ Time Frame: Baseline, 2 hours and 7 days ]
  • Iron levels [ Time Frame: Baseline, 2 hours and 7 days ]
  • Ferritin [ Time Frame: Baseline, 2 hours and 7 days ]
  • IGG [ Time Frame: Baseline, 2 hours and 7 days ]
  • B12 [ Time Frame: Baseline, 2 hours and 7 days ]

Enrollment: 0
Study Start Date: October 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01701531


Locations
United States, California
Lawrence May, MD, Inc.
Tarzana, California, United States, 91356
Sponsors and Collaborators
Targeted Medical Pharma
Investigators
Principal Investigator: Lawrence May, MD Lawrence May MD, Inc
  More Information

Responsible Party: Targeted Medical Pharma
ClinicalTrials.gov Identifier: NCT01701531     History of Changes
Other Study ID Numbers: RBC100312
First Submitted: October 3, 2012
First Posted: October 5, 2012
Last Update Posted: May 5, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Anemia
Hematologic Diseases