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

This study has been completed.
Sponsor:
Collaborator:
Tarix Pharmaceuticals
Information provided by (Responsible Party):
US Biotest, Inc.
ClinicalTrials.gov Identifier:
NCT01543971
First received: February 10, 2010
Last updated: February 27, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Miscellaneous Peripheral Blood Cell Abnormalities
Drug: TXA127
Drug: Neupogen (filgrastim)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase I Double-Blinded Comparison Study Using TXA127 and/or Neupogen to Increase Peripheral Blood Stem Cell (CD34+) Counts

Resource links provided by NLM:


Further study details as provided by US Biotest, Inc.:

Primary Outcome Measures:
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Assessed daily during dosing (Days 1 - 5) and at the two follow up visits (Day 7 and Day 12). ] [ Designated as safety issue: Yes ]
    In this phase I study the primary safety variables being assessd include laboratory variables (chemistry, hematology, coagulation system parameters, and urinalysis) and regular vital signs, injection site inspection, and physical exams as indicated.


Secondary Outcome Measures:
  • Preliminary effectiveness as assessed by changes in the concentration of peripheral blood stem cells (CD34+) and other hematologic parameters. [ Time Frame: Daily assessment during dosing (Days 1 - 5) and at the two follow up visits (Days 7 and 12) ] [ Designated as safety issue: Yes ]
    Parameters being assessed for preliminary effectiveness in this phase I study include routine chemistry and hematology parameters and flow-cytometric evaluation of blood samples for CD34, CD3, CD4, CD8 and CD19 concentrations at 4, 8, 12 and 16 hours post-dose


Enrollment: 18
Study Start Date: December 2009
Study Completion Date: March 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TXA127
(Group A) TXA127 at 300 mcg/kg once a day for 5 days
Drug: TXA127
TXA127 : 300mcg/kg per day for 5 days, injection
Other Names:
  • filgrastim
  • angiotensin 1-7
Active Comparator: Neupogen
(Group B) Neupogen 10 mcg/kg once a day for 5 days
Drug: Neupogen (filgrastim)
Neupogen : 10mcg/kg per day for 5 days, injection
Other Names:
  • filgrastim
  • angiotensin 1-7
Active Comparator: TXA127 and Neupogen
(Group C) both TXA127 (300mcg/kg) and Neupogen (10mcg/kg) together once a day for 5 days
Drug: TXA127
TXA127 : 300mcg/kg per day for 5 days, injection
Other Names:
  • filgrastim
  • angiotensin 1-7
Drug: Neupogen (filgrastim)
Neupogen : 10mcg/kg per day for 5 days, injection
Other Names:
  • filgrastim
  • angiotensin 1-7

Detailed Description:

In this double-blinded comparison study, healthy volunteers will be randomized to one of 3 treatment groups: (Group A) TXA127 at 300 mcg/kg once a day for 5 days or (Group B) Neupogen 10 mcg/kg once a day for 5 days or (Group C) both together once a day for 5 days, these treatments administered by subcutaneous injection, to increase peripheral blood stem cell (CD34+) concentrations in healthy volunteers.

A minimum of 18 healthy male and female volunteer Subjects (6 in each treatment group) who meet all inclusion and none of the exclusion criteria will be enrolled in this study. Subjects will be recruited from the study center's existing database of healthy volunteers and/or by advertising. A sufficient number of alternate volunteers will be screened and checked-in on Day 0 to ensure 6 eligible healthy volunteers are enrolled on Day 1 in each treatment group. Subjects will remain housed in teh Unit during the conduct of this study.

Safety: Predose blood samples will be collected immediately prior to receiving the study medication(s), as well as at 4 hours, 8 hours, 12 hours and 16 hours post-dose.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Volunteer is capable of reading, understanding and complying with the protocol, has been informed of the nature and risks of study participation and has signed the informed consent document prior to undergoing any study related procedures.
  • Volunteer is male or female and is 18 to 45 years of age, inclusive. If female, must be non-lactating and have a negative serum pregnancy test result at screening and on admission.
  • Must be in good health and must weigh at least 45 kg, but not more than 90 kg and have a Body Mass Index (BMI) between 17.5 kg/m2 and 35 kg/m2.
  • Screening and admission clinical laboratory test results that are within lab's reference range or, if not, are considered not clinically significant by the Investigator.
  • Screening and admission 12-lead electrocardiograms (ECGs) that are normal or, if abnormal, are considered not clinically significant by the Investigator.
  • Have negative urine drug and alcohol toxicology screens at screening and on admission, with negative HIV antibody and hepatitis panel results at screening.

Exclusion Criteria:

  • History of acute or chronic medical condition or test abnormality that would significantly increase Volunteer's risk of study participation or significantly increase risk of not achieving study objectives, in the Investigator's opinion.
  • Has known or suspected liver disease (active hepatitis, cirrhosis, hepatic insufficiency or ascites) or has a transaminase value > 2x ULN or total bilirubin > 1.5 x ULN, a history of spleen enlargement, except if due to infectious mononucleosis resolved more than 6 months prior to scheduled admission, or a current finding of spleen enlargement. Has a history of mononucleosis within previous six months of scheduled admission.
  • Has an abnormally low Protein C or Protein S at screening, or screening laboratory tests indicate Factor V Leiden is present.
  • Has a history of venous thrombosis or pulmonary embolism, or has systolic blood pressure persistently >145 mm Hg or <90 mm Hg, or diastolic blood pressure persistently >90 mm Hg or <60 mm Hg at screening or on admission.
  • Has a heart rate persistently >90 beats/minute or <45 beats/minute on vital signs testing at screening or on admission, or a 10-second ECG at Screening, Admission or Baseline (prior to first dose) showing any of the following:

    • HR that is < 45 or > 90 bpm;
    • QRS interval that is > 120 msec;
    • PR interval that is <120 or >220 msec;
    • QTcF that is < 300 msec or > 450 msec;
    • Any fascicular block or bundle branch block;
    • Neuromuscular ECG artifact that cannot be readily eliminated.
  • Has a history of substance abuse, drug addiction, or alcoholism within 1 year prior to screening. (As defined by DSM IV criteria).
  • Within 2 weeks prior to scheduled administration of study drug, Volunteer has taken any prescription or over-the-counter medication, herbal preparation or dietary supplement that, in the opinion of the Investigator, may increase risk to Volunteer's safety or to achievement of study objectives.
  • Unwilling to abstain from alcohol use or from caffeine from 24 hours prior to admission.
  • Has donated blood or blood products within 30 days prior to admission; is considered mentally unstable or exhibits anxious, excitable, hostile, or emotionally reactive affect; has received an investigational test substance within 30 days prior to the scheduled administration of investigational test article, or anticipates receiving any investigational test substance other than TXA127 during the course of this study.
  • Volunteer has previously participated in a clinical study of TXA127.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01543971

Locations
United States, Washington
Charles River Clinical Servies Norhtwest
Tacoma, Washington, United States, 98418
Sponsors and Collaborators
US Biotest, Inc.
Tarix Pharmaceuticals
Investigators
Study Director: Gere diZerega, MD US Biotest, Inc.
  More Information

No publications provided

Responsible Party: US Biotest, Inc.
ClinicalTrials.gov Identifier: NCT01543971     History of Changes
Other Study ID Numbers: TXA127-2009-003
Study First Received: February 10, 2010
Last Updated: February 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by US Biotest, Inc.:
Peripheral blood stem cell mobilization
CD34+ count

Additional relevant MeSH terms:
Angiotensin I (1-7)
Lenograstim
Adjuvants, Immunologic
Antihypertensive Agents
Cardiovascular Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 24, 2014