Trial Outcomes & Findings for Study of the Effect of a 5-Day Regimen of Study Drug on Peripheral Stem Cell Mobilization in Healthy Participants (NCT NCT03029000)
NCT ID: NCT03029000
Last Updated: 2022-12-13
Results Overview
The measurement of CD34+ cells in the apheresis product was performed by the local laboratory according to institutional guidelines.
TERMINATED
PHASE3
1 participants
Day 5
2022-12-13
Participant Flow
A total of 6 participants were screened for this study, of which 5 participants were considered a screen failure mainly due to inclusion criteria not met or exclusion criteria met. Only one participant was enrolled and treated in this study.
Participant milestones
| Measure |
Tbo-Filgrastim (GRANIX)
Participant received tbo-filgrastim 10 micrograms per kilogram (mcg/kg) of body weight, administered subcutaneously on the morning of Days 1 to 5.
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the Effect of a 5-Day Regimen of Study Drug on Peripheral Stem Cell Mobilization in Healthy Participants
Baseline characteristics by cohort
| Measure |
Tbo-Filgrastim (GRANIX)
n=1 Participants
Participant received tbo-filgrastim 10 mcg/kg of body weight, administered subcutaneously on the morning of Days 1 to 5.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 5Population: Participants who received 5-day regimen of tbo-filgrastim 10 mcg/kg of body weight; and for whom, Day 5 apheresis was performed as planned and a quantifiable count of CD34+ cells in blood collected in Day 5 apheresis was measured.
The measurement of CD34+ cells in the apheresis product was performed by the local laboratory according to institutional guidelines.
Outcome measures
| Measure |
Tbo-Filgrastim (GRANIX)
n=1 Participants
Participant received tbo-filgrastim 10 mcg/kg of body weight, administered subcutaneously on the morning of Days 1 to 5.
|
|---|---|
|
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 percentage of participants
|
SECONDARY outcome
Timeframe: Day 5Population: Participants who received 5-day regimen of tbo-filgrastim 10 mcg/kg of body weight; and for whom, Day 5 apheresis was performed as planned and a quantifiable count of CD34+ cells in blood collected in Day 5 apheresis was measured.
The measurement of CD34+ cells in the apheresis product was performed by the local laboratory according to institutional guidelines.
Outcome measures
| Measure |
Tbo-Filgrastim (GRANIX)
n=1 Participants
Participant received tbo-filgrastim 10 mcg/kg of body weight, administered subcutaneously on the morning of Days 1 to 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
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Day 5Population: Participants who received 5-day regimen of tbo-filgrastim 10 mcg/kg of body weight; and for whom, Day 5 apheresis was performed as planned and a quantifiable count of CD34+ cells in blood collected in Day 5 apheresis was measured.
The measurement of CD34+ cells in the apheresis product was performed by the local laboratory according to institutional guidelines.
Outcome measures
| Measure |
Tbo-Filgrastim (GRANIX)
n=1 Participants
Participant received tbo-filgrastim 10 mcg/kg of body weight, administered subcutaneously on the morning of Days 1 to 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
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Days 5 to 8Population: Participants who received 5-day regimen of tbo-filgrastim 10 mcg/kg of body weight; and for whom, Day 5 apheresis was performed as planned and a quantifiable count of CD34+ cells in blood collected in Day 5 apheresis was measured.
The measurement of CD34+ cells in the apheresis product was performed by the local laboratory according to institutional guidelines.
Outcome measures
| Measure |
Tbo-Filgrastim (GRANIX)
n=1 Participants
Participant received tbo-filgrastim 10 mcg/kg of body weight, administered subcutaneously on the morning of Days 1 to 5.
|
|---|---|
|
Number of Aphereses Necessary to Collect at Least 5*10^6 CD34+ Cells/kg of Recipient Body Weight
|
1 aphereses
|
SECONDARY outcome
Timeframe: From first administration of study drug (Day 1) up to early termination/end of study (up to approximately 3 months)Population: Safety analysis set included all participants who received at least 1 dose of tbo-filgrastim.
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.
Outcome measures
| Measure |
Tbo-Filgrastim (GRANIX)
n=1 Participants
Participant received tbo-filgrastim 10 mcg/kg of body weight, administered subcutaneously on the morning of Days 1 to 5.
|
|---|---|
|
Percentage of Participants With Adverse Events (AEs)
|
100 percentage of particicpants
|
SECONDARY outcome
Timeframe: Baseline (Day -3) up to early termination/end of study (up to approximately 3 months)Population: Safety analysis set included all participants who received at least 1 dose of tbo-filgrastim.
Blood samples (5 milliliters \[mL\]) for analysis of ADA were obtained for all participants at timepoints described.
Outcome measures
| Measure |
Tbo-Filgrastim (GRANIX)
n=1 Participants
Participant received tbo-filgrastim 10 mcg/kg of body weight, administered subcutaneously on the morning of Days 1 to 5.
|
|---|---|
|
Percentage of Participants With Anti-Drug Antibodies (ADA)
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 4 (8 hours post-dose)Population: PK analysis set included all participants who received at least 1 dose of tbo-filgrastim and had at least 1 calculated PK parameter for tbo-filgrastim.
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.
Outcome measures
| Measure |
Tbo-Filgrastim (GRANIX)
n=1 Participants
Participant received tbo-filgrastim 10 mcg/kg of body weight, administered subcutaneously on the morning of Days 1 to 5.
|
|---|---|
|
Maximum Observed Serum Recombinant Methionyl Human Granulocyte Colony-Stimulating Factor (r-metHuG-CSF) Concentration (Cmax)
|
19912.8 picograms per milliliter (pg/mL)
|
SECONDARY outcome
Timeframe: Between Day 1 (pre-dose) and before the first apheresis on Day 5Population: Pharmacodynamic (PD) analysis set included all participants who received at least 1 dose of tbo-filgrastim and had at least 1 calculated PD parameter.
Serial blood samples for the determination of CD34+ cell count were drawn.
Outcome measures
| Measure |
Tbo-Filgrastim (GRANIX)
n=1 Participants
Participant received tbo-filgrastim 10 mcg/kg of body weight, administered subcutaneously on the morning of Days 1 to 5.
|
|---|---|
|
Maximum Observed Peripheral CD34+ Cell Count (CD34+Cmax)
|
144 cells per microliter (cells/mcL)
|
Adverse Events
Tbo-Filgrastim (GRANIX)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tbo-Filgrastim (GRANIX)
n=1 participants at risk
Participant received tbo-filgrastim 10 mcg/kg of body weight, administered subcutaneously on the morning of Days 1 to 5.
|
|---|---|
|
General disorders
Pain
|
100.0%
1/1 • From first administration of study drug (Day 1) up to early termination/end of study (up to approximately 3 months)
Safety analysis set included all participants who received at least 1 dose of tbo-filgrastim.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
100.0%
1/1 • From first administration of study drug (Day 1) up to early termination/end of study (up to approximately 3 months)
Safety analysis set included all participants who received at least 1 dose of tbo-filgrastim.
|
|
Infections and infestations
Nasopharyngitis
|
100.0%
1/1 • From first administration of study drug (Day 1) up to early termination/end of study (up to approximately 3 months)
Safety analysis set included all participants who received at least 1 dose of tbo-filgrastim.
|
|
Nervous system disorders
Headache
|
100.0%
1/1 • From first administration of study drug (Day 1) up to early termination/end of study (up to approximately 3 months)
Safety analysis set included all participants who received at least 1 dose of tbo-filgrastim.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • From first administration of study drug (Day 1) up to early termination/end of study (up to approximately 3 months)
Safety analysis set included all participants who received at least 1 dose of tbo-filgrastim.
|
|
Renal and urinary disorders
Dysuria
|
100.0%
1/1 • From first administration of study drug (Day 1) up to early termination/end of study (up to approximately 3 months)
Safety analysis set included all participants who received at least 1 dose of tbo-filgrastim.
|
|
Infections and infestations
Urinary tract infection
|
100.0%
1/1 • From first administration of study drug (Day 1) up to early termination/end of study (up to approximately 3 months)
Safety analysis set included all participants who received at least 1 dose of tbo-filgrastim.
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products, R&D Inc
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
- Publication restrictions are in place
Restriction type: OTHER