Miscellaneous Peripheral Blood Cell AbnormalitiesPhase 1NCT01543971

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

A Phase 1 study testing TXA127 and Neupogen (filgrastim) in people with Miscellaneous Peripheral Blood Cell Abnormalities, run by Tarix Pharmaceuticals at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Miscellaneous Peripheral Blood Cell Abnormalities
What is being tested?: TXA127 and Neupogen (filgrastim)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: Dec 2009to Mar 2010
Phase: Phase 1
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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Charles River Clinical Servies Norhtwest
Tacoma, Washington, 98418

Other trials in United States

About this study

Official title: Phase I Double-Blinded Comparison Study Using TXA127 and/or Neupogen to Increase Peripheral Blood Stem Cell (CD34+) Counts

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.

Read the 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.

Conditions: Miscellaneous Peripheral Blood Cell Abnormalities
Being tested: TXA127, Neupogen (filgrastim)
Keywords: Peripheral blood stem cell mobilization, CD34+ count

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TXA127Drug
Also called filgrastim, angiotensin 1-7
TXA127 : 300mcg/kg per day for 5 days, injection
Neupogen (filgrastim)Drug
Also called filgrastim, angiotensin 1-7
Neupogen : 10mcg/kg per day for 5 days, injection

Study groups in NCT01543971
Study group	Role	What they receive
TXA127	Active comparator	(Group A) TXA127 at 300 mcg/kg once a day for 5 days Receives: Drug: TXA127
Neupogen	Active comparator	(Group B) Neupogen 10 mcg/kg once a day for 5 days Receives: Drug: Neupogen (filgrastim)
TXA127 and Neupogen	Active comparator	(Group C) both TXA127 (300mcg/kg) and Neupogen (10mcg/kg) together once a day for 5 days Receives: Drug: TXA127; Drug: Neupogen (filgrastim)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants with adverse events as a measure of safety and tolerability
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.
Measured: Assessed daily during dosing (Days 1 - 5) and at the two follow up visits (Day 7 and Day 12).

Secondary outcomes (1)

Preliminary effectiveness as assessed by changes in the concentration of peripheral blood stem cells (CD34+) and other hematologic parameters.
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
Measured: Daily assessment during dosing (Days 1 - 5) and at the two follow up visits (Days 7 and 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2009Mar 2010

First posted5 Mar 2012 (estimated)
Study startDec 2009
Primary completionDec 2009
Study completionMar 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Miscellaneous Peripheral Blood Cell AbnormalitiesStudies 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01543971
Sponsor's protocol ID: TXA127-2009-003
Status last verified: Aug 2016
First submitted: 10 Feb 2010
Last updated: 31 Aug 2016
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Double-Blinded Comparison Study Using TXA127 and/or Neupogen to Increase Peripheral Blood Stem Cell (CD34+) Counts
ClinicalTrials.gov ID: NCT01543971
Acronym / sponsor ID: TXA127-2009-003
Conditions: Miscellaneous Peripheral Blood Cell Abnormalities
Keywords: Peripheral blood stem cell mobilization, CD34+ count
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Tarix PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Dec 2009
Primary completion: Dec 2009 (actual)
Study completion: Mar 2010 (actual)
First posted: 5 Mar 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.

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.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
TXA127	Active comparator	Drug: TXA127(Group A) TXA127 at 300 mcg/kg once a day for 5 days
Neupogen	Active comparator	Drug: Neupogen (filgrastim)(Group B) Neupogen 10 mcg/kg once a day for 5 days
TXA127 and Neupogen	Active comparator	Drug: TXA127, Drug: Neupogen (filgrastim)(Group C) both TXA127 (300mcg/kg) and Neupogen (10mcg/kg) together once a day for 5 days

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (16 listed)

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:

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
TXA127Also: filgrastim, angiotensin 1-7TXA127 : 300mcg/kg per day for 5 days, injection	Drug	TXA127, TXA127 and Neupogen
Neupogen (filgrastim)Also: filgrastim, angiotensin 1-7Neupogen : 10mcg/kg per day for 5 days, injection	Drug	Neupogen, TXA127 and Neupogen

Primary outcome

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).
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.

1 secondary outcome

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)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.

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.

Gere diZerega, MD study director

US Biotest, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TXA127 and Neupogen (filgrastim) in people with Miscellaneous Peripheral Blood Cell Abnormalities, run by Tarix Pharmaceuticals 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 6 inclusion and 16 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: finished, as of the sponsor's last update on 31 Aug 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 phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01543971.

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 31 Aug 2016.