MedTrace Logo

Safety and Efficacy of TXA127 and Neupogen to Increase Peripheral Blood Stem Cells (PBSCs)

NCT01543971 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2016-08-31

No results posted yet for this study

Summary

This is a Phase I Study to be conducted in 18 healthy volunteers. Each will receive daily injections for 5 days of TXA127 alone, or Neupogen alone, or TXA127 plus Neupogen together.

The aim of the study is to determine the safety of the TXA127 alone and in combination with Neupogen, and to determine whether the use of TXA127 alone or in combination with Neupogen enhances peripheral blood stem cell (CD34+)mobilization.

Conditions

  • Miscellaneous Peripheral Blood Cell Abnormalities

Interventions

DRUG

TXA127

TXA127 : 300mcg/kg per day for 5 days, injection

DRUG

Neupogen (filgrastim)

Neupogen : 10mcg/kg per day for 5 days, injection

Sponsors & Collaborators

  • Tarix Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Gere diZerega, MD · US Biotest, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2009-12-31
Completion
2010-03-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01543971 on ClinicalTrials.gov