A Phase 3 interventional study of Tbo-filgrastim in Healthy Participants, sponsored by Teva Branded Pharmaceutical Products R&D, Inc.. Terminated at 9 sites in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-13.
Sponsored by Teva Branded Pharmaceutical Products R&D, Inc. · Phase 3, Interventional, and Treatment
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.
Teva Branded Pharmaceutical Products R&D, Inc. is the lead sponsor of 205 studies on the registry; none are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 47 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The participant has taken any of the following investigational medicinal products (IMPs), medicinal products, or substances:
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:
Participants 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.
Drug: Tbo-filgrastim
solution for subcutaneous injection
Also known as: XM02
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.
Time frame: Day 5
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.
Time frame: Day 5
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.
Time frame: Day 5
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.
Time frame: Days 5 to 8
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.
Time frame: From first administration of study drug (Day 1) up to early termination/end of study (up to approximately 3 months)
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.
Time frame: Baseline (Day -3) up to early termination/end of study (up to approximately 3 months)
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.
Time frame: Day 4 (8 hours post-dose)
Maximum Observed Peripheral CD34+ Cell Count (CD34+Cmax)
Serial blood samples for the determination of CD34+ cell count were drawn.
Time frame: Between Day 1 (pre-dose) and before the first apheresis on Day 5
| Milestone | Tbo-Filgrastim (GRANIX) |
|---|---|
| Started | 1 |
| Completed | 1 |
| Not completed | 0 |
The measurement of CD34+ cells in the apheresis product was performed by the local laboratory according to institutional guidelines.
| percentage of participants | Tbo-Filgrastim (GRANIX) |
|---|---|
| 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 | 100 |
The measurement of CD34+ cells in the apheresis product was performed by the local laboratory according to institutional guidelines.
| percentage of participants | Tbo-Filgrastim (GRANIX) |
|---|---|
| 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 | 100 |
The measurement of CD34+ cells in the apheresis product was performed by the local laboratory according to institutional guidelines.
| percentage of participants | Tbo-Filgrastim (GRANIX) |
|---|---|
| Percentage of Participants With at Least 5*10^6 CD34+ Cells/kg of Recipient Body Weight Collected After the First Apheresis on Day 5 | 100 |
The measurement of CD34+ cells in the apheresis product was performed by the local laboratory according to institutional guidelines.
| aphereses | Tbo-Filgrastim (GRANIX) |
|---|---|
| Number of Aphereses Necessary to Collect at Least 5*10^6 CD34+ Cells/kg of Recipient Body Weight | 1 |
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.
| percentage of particicpants | Tbo-Filgrastim (GRANIX) |
|---|---|
| Percentage of Participants With Adverse Events (AEs) | 100 |
Blood samples (5 milliliters \[mL\]) for analysis of ADA were obtained for all participants at timepoints described.
| percentage of participants | Tbo-Filgrastim (GRANIX) |
|---|---|
| Percentage of Participants With Anti-Drug Antibodies (ADA) | 0 |
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.
| picograms per milliliter (pg/mL) | Tbo-Filgrastim (GRANIX) |
|---|---|
| Maximum Observed Serum Recombinant Methionyl Human Granulocyte Colony-Stimulating Factor (r-metHuG-CSF) Concentration (Cmax) | 19912.8 |
Serial blood samples for the determination of CD34+ cell count were drawn.
| cells per microliter (cells/mcL) | Tbo-Filgrastim (GRANIX) |
|---|---|
| Maximum Observed Peripheral CD34+ Cell Count (CD34+Cmax) | 144 |
Collected over From first administration of study drug (Day 1) up to early termination/end of study (up to approximately 3 months). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tbo-Filgrastim (GRANIX) | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Event | Tbo-Filgrastim (GRANIX) |
|---|---|
| PainGeneral disorders | 1/1 |
| Bone painMusculoskeletal and connective tissue disorders | 1/1 |
| NasopharyngitisInfections and infestations | 1/1 |
| HeadacheNervous system disorders | 1/1 |
| NauseaGastrointestinal disorders | 1/1 |
| DysuriaRenal and urinary disorders | 1/1 |
| Urinary tract infectionInfections and infestations | 1/1 |
All enrolled donor participants, regardless of whether or not a participant was administered tbo-filgrastim.
| Age, Categorical(Participants) | Tbo-Filgrastim (GRANIX) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Tbo-Filgrastim (GRANIX) |
|---|---|
| Female | 1 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | Tbo-Filgrastim (GRANIX) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 1 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
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Teva Branded Pharmaceutical Products R&D, Inc.