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Healthy ParticipantsPhase 3GRANIXNCT03029000

Study of the Effect of a 5-Day Regimen of Study Drug on Peripheral Stem Cell Mobilization in Healthy Participants

A Phase 3 study testing Tbo-filgrastim in people with Healthy Participants, run by Teva Branded Pharmaceutical Products R&D, Inc. at 9 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

A multi-center, open-label, single-arm clinical study to assess effects of a 5-day regimen of 10 micrograms per kilogram (mcg/kg) of tbo-filgrastim administered subcutaneously daily on the mobilization of cluster of differentiation 34+ (CD34+) cells in at least 60 healthy male and female participants. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
Tbo-filgrastim
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
9 sitesUnited States
Study dates
2 Aug 2017to 30 Oct 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Written informed consent is obtained from the participant
  • The participant has a body weight of at least 50 kilograms (kg)
  • The participant has a body mass index (BMI) of more than 18.5 and less than 35.0 kilograms per square meter (kg/m^2)
  • The participant is in good health as determined by medical and psychiatric history, physical examination, electrocardiogram (ECG) recordings, serum chemistry, hematology, coagulation, urinalysis, and serology
  • Women may be included only if they have a negative beta human chorionic gonadotropin (beta-hCG) test at baseline, are sterile (defined as documented hysterectomy, bilateral oophorectomy or bilateral salpingectomy, or congenitally sterile), or postmenopausal (defined as no menses for 12 months without alternative medical cause and increased follicle stimulating hormone [FSH] of above 35 units per liter [U/L] in women not using hormonal contraception or hormonal replacement therapy). Women of childbearing potential whose male partners are potentially fertile (that is, no vasectomy) must use highly effective birth control methods for the duration of the study and for 30 days after the last tbo-filgrastim administration
  • The participant has a negative alcohol urine test and a negative urine drug screen
  • The participant must be willing and able to comply with study restrictions
  • The participant is human leukocyte antigen (HLA) -matched or haploidentical-related to the recipient

Who cannot join

  • The participant currently has or had a history of any clinically relevant gastrointestinal, hematologic, respiratory, psychiatric, renal, hepatic, cardiac, metabolic (such as, fructose intolerance), neurological, or any other disease or condition which may influence the physiological metabolic turnover (such as, severe endocrine diseases, febrile condition, severe infections), which may interfere with the study objectives, or which could expose the participant to undue risk through the participation in the clinical study
  • The participant has had: (1) a trauma or surgery in the past 2 months; (2) a clinically relevant illness within 4 weeks before the first dose of tbo-filgrastim; (3) any acute illness within 1 week before the first dose of tbo-filgrastim; or (4) symptoms of any clinically relevant or acute illness at baseline
  • The participant has existence or recent history of persistent pulmonary infiltrates, recent pneumonia, recent bronchitis, recurrent lung infections, or history or evidence of any lung disease including asthma, or current symptoms of upper respiratory tract infection. In the case of pneumonia, participant may be screened 12 weeks after cessation of antibiotic treatment
  • The participant has findings of splenomegaly on sonography at screening, defined by length of spleen more than 12.3 centimeters (cm) and clinical judgment
  • The participant has a history of malignancy, including hematologic malignancy, except for appropriately treated non-melanoma skin carcinoma in the last 5 years
  • The participant has a clinically significant deviation from normal in ECG recordings or physical examination findings, as determined by the investigator
Show all 32Show fewer
  • The participant is pregnant or lactating, or was pregnant in the previous 6 months, or intends to get pregnant during the study or within 30 days after the last dose of study drug
  • The participant has habitually consumed, within the last 2 years, more than 21 units of alcohol per week, or has a history or evidence of alcohol, narcotic, or any other substance abuse as defined by the Diagnostic and Statistical Manual of Mental Disorder, Fifth Edition (DSM-V, American Psychiatric Association 2013). Note: A unit of alcohol is equal to 1 ounce (29.6 milliliters [mL]) of hard liquor, 5 ounces (148 mL) of wine, or 8 ounces (236.8 mL) of beer
  • The participant has taken any of the following investigational medicinal products (IMPs), medicinal products, or substances:
  • Any IMP within 30 days or 5 half-lives (whichever is longer) before the first dose of tbo-filgrastim, or in the case of a new chemical entity, 3 months or 5 half-lives (whichever is longer) before the first dose of tbo-filgrastim
  • Known history of treatment with blood-cell colony-stimulating factors
  • Current or recent (within 4 weeks) treatment with lithium
  • The participant has donated plasma within 7 days before screening or has donated blood within 56 days before screening
  • The participant has a documented or self-reported history of tuberculosis or recent travel to countries of endemic disease (last 8 weeks)
  • The participant has 1 or more clinical laboratory test value(s) outside the range specified below, or any other clinically significant laboratory abnormality as determined by the investigator or medical monitor:
  • Hemoglobin less than or equal to (<=) 12.5 grams per deciliter (g/dL) (women) and hemoglobin <=13.5 g/dL (men)
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values of greater than (>) 3 * the upper limit of the normal range (ULN)
  • Total bilirubin of >2 * ULN
  • Findings of cholestasis (eg, abnormal values of alkaline phosphatase)
  • The participant has a positive test result for human immunodeficiency virus (HIV), hepatitis B surface antigen, antibodies to hepatitis C virus, immunoglobulin M (IgM) antibodies to cytomegalovirus, human T-lymphotropic virus, West Nile virus, malaria, or syphilis
  • The participant has a documented or self-reported history of tuberculosis or recent travel to countries of endemic disease (last 8 weeks)
  • The participant has, after resting for 5 minutes, increased blood pressure (BP) (defined as systolic BP in seated position of more than 145 millimeters of mercury [mm Hg] or diastolic BP in seated position of more than 95 mm Hg), or low BP (defined as systolic BP in seated position of less than 90 mm Hg or diastolic BP in seated position of less than 45 mm Hg) (Only 2 rechecks of the participant's BP are permitted for eligibility purposes)
  • The participant has, after resting for 5 minutes, a pulse in seated position of less than 45 or more than 90 beats per minute (Only 2 rechecks of the participant's pulse are permitted for eligibility purposes)
  • The participant is unwilling to refrain from vigorous exercise (eg, strenuous or unaccustomed weight lifting, running, bicycling) from 72 hours before Day 1 until Day 15
  • The participant is unlikely to comply with the study protocol or is unsuitable for any other reasons, as judged by the investigator
  • The participant has a history of autoimmune disease, including rheumatic diseases and thyroid disorders
  • The participant has a history of deep vein thrombosis or pulmonary embolism
  • The participant has thrombocytopenia defined as platelet count <150 * 109 cells per liter (cells/L) at screening or at baseline
  • The participant has a history of bleeding problems (eg, hemophilia, thrombocytopenia, idiopathic thrombocytopenic purpura, clotting factor deficiencies or disorders)
  • The participant has positive hemoglobin-solubility test
  • The participant has a history of iritis or episcleritis
  • The participant has a history of significant hypersensitivity, intolerance, or allergy to tbo-filgrastim or any other E. coli derived product or excipient, or other medicinal product, food, or substance, unless approved by the investigator

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Teva Investigational Site 14023

    Beech Grove, Indiana, 46107

  • Teva Investigational Site 14027

    Chapel Hill, North Carolina, 27514

  • Teva Investigational Site 14030

    Cincinnati, Ohio, 45242

  • Teva Investigational Site 14026

    Detroit, Michigan, 48201

  • Teva Investigational Site 14029

    Duarte, California, 91010

  • Teva Investigational Site 14033

    Greenville, South Carolina, 29615

  • Teva Investigational Site 14025

    La Jolla, California, 92037-1027

  • Teva Investigational Site 14035

    Memphis, Tennessee, 38120

  • Teva Investigational Site 14024

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Single-Arm Study of the Effect of a 5-day Regimen of Tbo-Filgrastim 10 mcg/kg of Body Weight Administered Subcutaneously on Peripheral Stem Cell Mobilization in Healthy Donors

A multi-center, open-label, single-arm clinical study to assess effects of a 5-day regimen of 10 micrograms per kilogram (mcg/kg) of tbo-filgrastim administered subcutaneously daily on the mobilization of cluster of differentiation 34+ (CD34+) cells in at least 60 healthy male and female participants. The pharmacokinetics, pharmacodynamics, safety, tolerability, and immunogenicity of tbo-filgrastim will be assessed.

Being tested
Tbo-filgrastim

What participants receive

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

  • Tbo-filgrastimDrug

    Also called XM02

    solution for subcutaneous injection

Study groups in NCT03029000
Study groupRoleWhat they receive
Tbo-filgrastim (GRANIX)ExperimentalParticipants will receive tbo-filgrastim 10 mcg/kg of body weight, subcutaneously on the morning of Days 1 to 5. The actual dose of tbo-filgrastim administered to each, individual participant will be calculated at baseline according to his or her body weight and that specific dose (10 mcg/kg of body weight) for each, individual participant will remain the same for all consecutive daily doses. If the collection goal will not meet after the first apheresis on Day 5, tbo-filgrastim 10 mcg/kg of body weight will be administered subcutaneously for up to 3 additional days (Days 6 to 8) followed by daily apheresis to reach the cumulative collection goal.
Receives: Drug: Tbo-filgrastim

What is being measured

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

  1. Percentage of Participants With at Least 2*10^6 Cluster of Differentiation 34+ (CD34+) Cells Per Kilogram (Cells/kg) of Recipient Body Weight Collected in the First Apheresis on Day 5

    The measurement of CD34+ cells in the apheresis product was performed by the local laboratory according to institutional guidelines.

    Measured: Day 5

Secondary outcomes (7)

  1. Percentage of Participants With at Least 2*10^6 CD34+ Cells/kg of Donor Baseline Body Weight Collected After the First Apheresis on Day 5

    The measurement of CD34+ cells in the apheresis product was performed by the local laboratory according to institutional guidelines.

    Measured: Day 5

  2. Percentage of Participants With at Least 5*10^6 CD34+ Cells/kg of Recipient Body Weight Collected After the First Apheresis on Day 5

    The measurement of CD34+ cells in the apheresis product was performed by the local laboratory according to institutional guidelines.

    Measured: Day 5

  3. Number of Aphereses Necessary to Collect at Least 5*10^6 CD34+ Cells/kg of Recipient Body Weight

    The measurement of CD34+ cells in the apheresis product was performed by the local laboratory according to institutional guidelines.

    Measured: Days 5 to 8

  4. Percentage of Participants With Adverse Events (AEs)

    A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs presented here included both SAEs and non-serious AEs.

    Measured: From first administration of study drug (Day 1) up to early termination/end of study (up to approximately 3 months)

  5. Percentage of Participants With Anti-Drug Antibodies (ADA)

    Blood samples (5 milliliters [mL]) for analysis of ADA were obtained for all participants at timepoints described.

    Measured: Baseline (Day -3) up to early termination/end of study (up to approximately 3 months)

  6. Maximum Observed Serum Recombinant Methionyl Human Granulocyte Colony-Stimulating Factor (r-metHuG-CSF) Concentration (Cmax)

    Blood samples were drawn for all participants for the determination of serum r-metHuG-CSF concentrations on Day 4. Pharmacokinetic (PK) parameter was calculated from concentration-time data using non compartmental methods, when possible.

    Measured: Day 4 (8 hours post-dose)

  7. Maximum Observed Peripheral CD34+ Cell Count (CD34+Cmax)

    Serial blood samples for the determination of CD34+ cell count were drawn.

    Measured: Between Day 1 (pre-dose) and before the first apheresis on Day 5

Timeline

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

  1. First posted23 Jan 2017 (estimated)
  2. Study start2 Aug 2017
  3. Primary completion30 Oct 2017
  4. Study completion30 Oct 2017

Why it stopped: Study was terminated due to low enrollment

Resources

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03029000
Sponsor's protocol ID
TV44688-ONC-30054
Acronym
GRANIX
Status last verified
Dec 2022
First submitted
19 Jan 2017
Last updated
13 Dec 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tbo-filgrastim in people with Healthy Participants, run by Teva Branded Pharmaceutical Products R&D, Inc. at 9 sites 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 8 inclusion and 32 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: stopped early, as of the sponsor's last update on 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites 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 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?

Yes. Results are posted in the registry (first posted 14 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With at Least 2*10^6 Cluster of Differentiation 34+ (CD34+) Cells Per Kilogram (Cells/kg) of Recipient Body Weight Collected in the First Apheresis on Day 5 (time frame: Day 5). 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 NCT03029000.

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 13 Dec 2022.

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