AnemiaPhase 2/3RBCPFNCT01701531
Red Blood Cell Precursor Formulation to Determine Increased Production
A Phase 2/3 study testing RBCPF in people with Anemia, run by Targeted Medical Pharma at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anemia
- What is being tested?
- RBCPF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to May 2014
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- M/F patients 18 to 75 years old, non-pregnant/lactating
- Male patients with < Hemoglobin of 12.5
- Female Patients with < Hemoglobin of 11
- Diagnosis of mild to moderate anemia by study physician
Who cannot join
- Pregnant or unwilling to use adequate birth control for the duration of the study.
- Unwilling or unable to sign informed consent.
- Myocardial infarction within the last 6 months.
- Patients currently taking an erythropoietin medication and unable to discontinue for the duration of the study.
- GI bleed in the last 6 months.
- Inflammatory bowel disease.
- Chronic liver disease.
Trial locations and contacts
1 site in 1 country.
About this study
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
The objective of this study is to measure the change in hemoglobin levels after the administration of an amino acid based, RBC precursor formulation.
Read the 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.
- Conditions
- Anemia
- Being tested
- RBCPF
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBCPFDrug
Also called Red blood cell precursor formulation
| Study group | Role | What they receive |
|---|---|---|
| RBCPF | Experimental | Treatment intervention arm Receives: Drug: RBCPF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 2 hours and 7 days
Secondary outcomes (7)
CBC w/ differential
Measured: Baseline, 2 hours and 7 days
Erythropoietin level
Measured: Baseline, 2 hours and 7 days
Reticulocytes
Measured: Baseline, 2 hours and 7 days
Iron levels
Measured: Baseline, 2 hours and 7 days
Ferritin
Measured: Baseline, 2 hours and 7 days
IGG
Measured: Baseline, 2 hours and 7 days
B12
Measured: Baseline, 2 hours and 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: Funding not received
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Targeted Medical Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lawrence May, MD, Principal investigator, Lawrence May MD, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01701531
- Sponsor's protocol ID
- RBC100312
- Acronym
- RBCPF
- Status last verified
- May 2016
- First submitted
- 3 Oct 2012
- Last updated
- 5 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01701531
- Acronym / sponsor ID
- RBCPF / RBC100312
- Conditions
- Anemia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding not received
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Targeted Medical PharmaIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 5 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to measure the change in hemoglobin levels after the administration of an amino acid based, RBC 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RBCPF | Experimental | Drug: RBCPFTreatment intervention arm |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- M/F patients 18 to 75 years old, non-pregnant/lactating
- Male patients with < Hemoglobin of 12.5
- Female Patients with < Hemoglobin of 11
- Diagnosis of mild to moderate anemia by study physician
Key exclusion criteria (7 listed)
- Pregnant or unwilling to use adequate birth control for the duration of the study.
- Unwilling or unable to sign informed consent.
- Myocardial infarction within the last 6 months.
- Patients currently taking an erythropoietin medication and unable to discontinue for the duration of the study.
- GI bleed in the last 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RBCPFAlso: Red blood cell precursor formulation | Drug | RBCPF |
Primary outcome
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.
7 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence May, MD principal investigator
Lawrence May MD, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing RBCPF in people with Anemia, run by Targeted Medical Pharma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hemoglobin level 2 hours after administration of the first dose. (time frame: Baseline, 2 hours and 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2016.