Leucocytosis Clinical Trial
Official title:
Single-center Open Randomized Clinical Trial to Evaluate Pharmacokinetics, Pharmacodynamics and Safety of Leucostim® (JSC "BIOCAD", Russia) Compared to Neupogen® (F. Hoffman-La Roche Ltd., Switzerland)
| Verified date | December 2018 |
| Source | Biocad |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
BCD-002-1 is 1 phase clinical trial to evaluate pharmacokinetics, pharmacodynamics and safety of single-injection of Leucostim® to healthy volunteers compared to Neupogen®
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | November 11, 2016 |
| Est. primary completion date | November 11, 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years to 45 Years |
| Eligibility |
Inclusion Criteria: - Written informed consent. - Male gender. - Age between 18 and 45 years. - Normal body mass index. - Verified diagnosis "healthy", established according to the anamnesis, physical examination and laboratory findings. - Absence of alcohol or drug abuse. Exclusion Criteria: - History of use of filgrastim. - Allergy to any components of study drugs. - Acute hemorrhage, donation of blood / plasma or blood transfusions during last 2 months prior to enrollment in the study, history of chronic bleeding. - Surgical interventions during last 30 days prior to screening or planed surgical intervention during the study. - Any diseases that could interfere with pharmacokinetics of filgrastim, including chronic liver, liver or blood diseases, diseases of cardiovascular, lung and neuroendocrine systems. - Fever with body temperature higher than 40°?. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Biocad |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | AUC (0-48 Hours) | Area Under Curve (AUC) "concentration - time" from the moment of filgrastim injection to 48 hours | 0 to 48 hours post-dose | |
| Primary | Cmax After Subcutaneous Injection | Maximal concentration of filgrastim after subcutaneous injection of filgrastim | 0 to 48 hours post-dose | |
| Secondary | Cmax After Intravenous Injection | Maximal concentration of filgrastim after intravenous injection of filgrastim | 0 to 48 hours post-dose | |
| Secondary | Tmax After Injection | Time after single injection to reach maximal concentration of filgrastim | 0 to 48 hours post-dose | |
| Secondary | ?½ | Half-life of filgrastim after single injection of filgrastim | 0 to 48 hours post-dose | |
| Secondary | Kel | The elimination rate constant after single injection of filgrastim | 0 to 48 hours post-dose | |
| Secondary | Clearance | Clearance of filgrastim after single injection | 0 to 48 hours post-dose | |
| Secondary | ANC-AUEC (0-336 Hours) | Area Under Effect Curve (AUEC) "effect - time" from the moment of filgrastim injection to 336 hours based on absolute neutrophil count (ANC) | 0 to 336 hours post-dose | |
| Secondary | ANC-Emax | Maximal absolute neutrophil count after single filgrastim injection | 0 to 336 hours post-dose | |
| Secondary | CD34-AUEC (0-336 Hours) | Area Under Effect Curve (AUEC) "effect - time" from the moment of filgrastim injection to 336 hours based on CD-34 cells count (CD34) | 0 to 336 hours post-dose | |
| Secondary | CD34-Emax | Maximal absolute count of CD34-cells after single filgrastim injection | 0 to 336 hours post-dose | |
| Secondary | Overall Frequency of Serious Adverse Events (SAE) | 0 to 336 hours post-dose | ||
| Secondary | Overall Frequency of Adverse Events (AE) | 0 to 336 hours post-dose | ||
| Secondary | Frequency of Local Reactions | 0 to 336 hours post-dose | ||
| Secondary | Frequency of AE/SAE 3-4 Grade CTCAE 4.03 | Grading scale of CTCAE 4.03 Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL (activities of daily living). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. |
0 to 336 hours post-dose | |
| Secondary | Frequency of Preliminary Withdrawal Due to AE/SAE | 0 to 336 hours post-dose | ||
| Secondary | Proportion of Patients With Binding or Neutralizing Antibodies to Filgrastim | Proportion of patients who had developed binding or neutralizing antibodies to filgrastim after single injection. | 0 to 336 hours post-dose |