NCT01701531

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

May 5, 2016

Status Verified

May 1, 2016

Enrollment Period

1.6 years

First QC Date

October 3, 2012

Last Update Submit

May 4, 2016

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

  • CBC w/ differential

    Baseline, 2 hours and 7 days

  • Erythropoietin level

    Baseline, 2 hours and 7 days

  • Reticulocytes

    Baseline, 2 hours and 7 days

  • Iron levels

    Baseline, 2 hours and 7 days

  • Ferritin

    Baseline, 2 hours and 7 days

  • +2 more secondary outcomes

Study Arms (1)

RBCPF

EXPERIMENTAL

Treatment intervention arm

Drug: RBCPF

Interventions

RBCPFDRUG
Also known as: Red blood cell precursor formulation
RBCPF

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lawrence May, MD, Inc.

Tarzana, California, 91356, United States

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Lawrence May, MD

    Lawrence May MD, Inc

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2012

First Posted

October 5, 2012

Study Start

October 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

May 5, 2016

Record last verified: 2016-05

Locations

US(1)