Trial · NCT07877467
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum observed serum filgrastim concentration (Cmax) | Pre-dose (-0.5 h) and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose, in each treatment period. | To compare the maximum observed serum filgrastim concentration (Cmax) following administration of Biofilgragen (test product) and EU-authorized Neupogen (reference product). Serum filgrastim concentrations will be measured using a validated enzyme-linked immunosorbent assay (ELISA) from serial blood samples collected at the protocol-specified pharmacokinetic sampling time points. Cmax will be derived using non-compartmental analysis. Pharmacokinetic similarity will be assessed using the two-sided 90% confidence interval for the test-to-reference geometric mean ratio, with acceptance limits of 80% to 125%. |
| Primary | Time to reach maximum observed serum filgrastim concentration (tmax) (hours) | Pre-dose (-0.5 h) and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose, in each treatment period. | To determine the time to reach the maximum observed serum filgrastim concentration (tmax) following administration of Biofilgragen and EU-authorized Neupogen. The parameter will be derived from the serum concentration-time profile using non-compartmental analysis and expressed in hours. Results will be summarized descriptively. |
| Primary | Area under the serum filgrastim concentration-time curve from time zero to infinity (AUC0-inf) | Pre-dose (-0.5 h) and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose, in each treatment period; AUC extrapolated to infinity. | To compare the area under the serum filgrastim concentration-time curve from time zero extrapolated to infinity (AUC0-inf) following administration of Biofilgragen and EU-authorized Neupogen. The parameter will be calculated from serial serum concentration measurements using non-compartmental analysis. Pharmacokinetic similarity will be assessed using the two-sided 90% confidence interval for the test-to-reference geometric mean ratio, with acceptance limits of 80% to 125%. |
| Primary | Terminal elimination half-life of serum filgrastim (t½) (hours) | Pre-dose (-0.5 h) and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose, in each treatment period. | To determine the terminal elimination half-life (t1/2) of serum filgrastim following administration of Biofilgragen and EU-authorized Neupogen. The parameter will be derived from the serum concentration-time profile using non-compartmental analysis and expressed in hours. Results will be summarized descriptively. |
| Secondary | Maximum observed absolute neutrophil count (ANCmax) (cells/µL) | Pre-dose (-0.5 h) and 4, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours post-dose, in each treatment period. | To compare the maximum observed absolute neutrophil count (ANCmax) following administration of Biofilgragen and EU-authorized Neupogen. ANC will be measured using a validated automated hematology analyzer, and ANCmax will be derived from serial ANC measurements collected at the protocol-specified pharmacodynamic sampling time points. |
| Secondary | Time to maximum observed absolute neutrophil count (time to ANCmax) (hours) | Pre-dose (-0.5 h) and 4, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours post-dose, in each treatment period. | To determine the time to reach the maximum observed absolute neutrophil count (tmax, ANC) following administration of Biofilgragen and EU-authorized Neupogen. The parameter will be derived from serial ANC measurements and expressed in hours. |
| Secondary | Area under the absolute neutrophil count-time curve from time zero to 96 hours (AUEC0-96h) | Pre-dose (-0.5 h) and 4, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours post-dose, in each treatment period. | To compare the area under the absolute neutrophil count-time curve from time zero to 96 hours post-dose (AUEC0-96h) following administration of Biofilgragen and EU-authorized Neupogen. The parameter will be calculated from serial ANC measurements collected during the 96-hour post-dose assessment period. |
| Secondary | Incidence of treatment-emergent anti-drug antibodies (ADA) | Predose in Treatment Period 1 (baseline), predose in Treatment Period 2, and at the final Follow-up visit (Day 69 + 7 days). | To evaluate the incidence of treatment-emergent anti-drug antibodies (ADA) against filgrastim following administration of Biofilgragen and EU-authorized Neupogen. Treatment-emergent ADA will be defined as a negative baseline ADA result followed by one or more confirmed positive ADA results after treatment. ADA will be assessed using the study-specified validated immunogenicity testing method. Results will be summarized by the number and percentage of participants meeting the definition. |
| Secondary | Incidence of neutralizing antibodies (NAb) | Predose in Treatment Period 1 (baseline), predose in Treatment Period 2, and at the final Follow-up visit (Day 69 + 7 days). | To evaluate the incidence of neutralizing antibodies (NAb) against filgrastim following administration of Biofilgragen and EU-authorized Neupogen. NAb testing will be performed for confirmed ADA-positive samples, where applicable, using the study-specified neutralizing antibody assay. Results will be summarized by the number and percentage of participants with detected neutralizing antibodies. |
| Secondary | Incidence, severity, and relationship to study treatment of adverse events (AEs) | From signing the Informed Consent Form through the final Follow-up visit (Day 69 + 7 days). | To evaluate the incidence, severity, and relationship to study treatment of adverse events (AEs) following administration of Biofilgragen and EU-authorized Neupogen. AEs will be recorded, assessed, and classified according to the study protocol, including assessment of severity and relationship to study treatment. Events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), Version 29.0. Results will be summarized by the number and percentage of participants experiencing AEs, with severity and relationship reported as applicable. |
| Secondary | Incidence, severity, and relationship to study treatment of serious adverse events (SAEs) | From signing the Informed Consent Form through the final Follow-up visit (Day 69 + 7 days). | To evaluate the incidence, severity, and relationship to study treatment of serious adverse events (SAEs) following administration of Biofilgragen and EU-authorized Neupogen. SAEs will be recorded, assessed, and classified according to the study protocol and coded using the Medical Dictionary for Regulatory Activities (MedDRA), Version 29.0. Results will be summarized by the number and percentage of participants experiencing SAEs, with severity and relationship to study treatment reported as applicable. |
| Secondary | Incidence of adverse events of special interest (AESIs) | From signing the Informed Consent Form through the final Follow-up visit (Day 69 + 7 days). | To evaluate the incidence of adverse events of special interest (AESIs), including splenic events, pulmonary events, capillary leak syndrome, vasculitis, glomerulonephritis, and hypersensitivity reactions. AESIs will be recorded and assessed according to the study protocol and coded using the Medical Dictionary for Regulatory Activities (MedDRA), Version 29.0. Results will be summarized by the number and percentage of participants experiencing AESIs. |
| Secondary | Physical examination findings | Screening, Treatment Periods 1 and 2, and at the final Follow-up visit (Day 69 + 7 days). | To assess physical examination findings following the protocol-specified complete physical examination, covering general appearance; head, eyes, ears, nose, and throat; cardiovascular, respiratory, abdominal, musculoskeletal, neurologic, and skin systems. Findings will be documented and clinically significant abnormalities will be evaluated according to the study protocol. |
| Secondary | Change in Systolic Blood Pressure from Baseline (mmHg) | Screening, Treatment Periods 1 and 2, and at the final Follow-up (Day 69 + 7 days). | To evaluate systolic blood pressure following administration of Biofilgragen and EU-authorized Neupogen. Systolic blood pressure will be measured using the protocol-specified standardized vital-sign assessment procedure and recorded in millimeters of mercury (mmHg). Changes and clinically significant findings will be assessed according to the study protocol. |
| Secondary | Change in Diastolic Blood Pressure from Baseline (mmHg) | Screening, Treatment Periods 1 and 2, and at the final Follow-up (Day 69 + 7 days). | To evaluate diastolic blood pressure following administration of Biofilgragen and EU-authorized Neupogen. Diastolic blood pressure will be measured using the protocol-specified standardized vital-sign assessment procedure and recorded in millimeters of mercury (mmHg). Changes and clinically significant findings will be assessed according to the study protocol. |
| Secondary | Change in Heart Rate from Baseline (beats/minute) | Screening, Treatment Periods 1 and 2, and at the final Follow-up (Day 69 + 7 days). | To evaluate heart rate following administration of Biofilgragen and EU-authorized Neupogen. Heart rate will be measured using the protocol-specified standardized vital-sign assessment procedure and recorded in beats per minute. Changes and clinically significant findings will be assessed according to the study protocol. |
| Secondary | Change in Respiratory Rate from Baseline (breaths/minute) | Screening, Treatment Periods 1 and 2, and at the final Follow-up (Day 69 + 7 days). | To evaluate respiratory rate following administration of Biofilgragen and EU-authorized Neupogen. Respiratory rate will be measured using the protocol-specified standardized vital-sign assessment procedure and recorded in breaths per minute. Changes and clinically significant findings will be assessed according to the study protocol. |
| Secondary | Change in Body Temperature from Baseline (°C) | Screening, Treatment Periods 1 and 2, and at the final Follow-up (Day 69 + 7 days). | To evaluate body temperature following administration of Biofilgragen and EU-authorized Neupogen. Body temperature will be measured using the protocol-specified vital-sign assessment procedure and recorded in degrees Celsius (°C). Changes and clinically significant findings will be assessed according to the study protocol. |
| Secondary | 12-lead resting electrocardiogram (ECG) findings | Screening and at the final Follow-up visit (Day 69 + 7 days). | To assess cardiac findings using a 12-lead resting electrocardiogram (ECG) performed according to the study protocol. ECG findings will be reviewed and documented, and clinically significant abnormalities will be evaluated by the Investigator. |
| Secondary | Chest X-Ray Findings | Screening and at the final Follow-up visit (Day 69 + 7 days). | To assess pulmonary findings using chest X-ray examinations performed according to the study protocol. Findings will be reviewed and documented, and clinically significant abnormalities will be evaluated by the Investigator. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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