Clinical trial NCT03961009: Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in PID Patients
Official title: A Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety and Pharmacokinetics of Kedrion Intravenous Immunoglobulin (IVIg) 10% in Primary Immunodeficiency Disease (PID) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Immunodeficiency Disease
Keywords: Immunoglobulin
Kedrion IVIg10%
IgG antibodies
Agammaglobulinemia
Hypogammaglobulinemia
Lead sponsor: Kedrion S.p.A.
Sponsor class: INDUSTRY
First posted: 2019-05-23
Enrollment: 47
Sex: ALL
Minimum age (years): 2
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to assess efficacy and safety of Kedrion Immunoglobulin 10% (KIg10) in participants with Primary Immunodeficiency (PID).


Eligibility criteria: Inclusion Criteria:

* Written informed consent/assent obtained from participant/participant's parent(s) or legally acceptable representative indicating that they understand the purpose of and procedures required for the study and are willing to participate in it.
* Confirmed clinical diagnosis of a PID, requiring treatment with IVIg and have documented agammaglobulinemia (defined as the total absence of one or more classes of antibodies) or hypogammaglobulinemia (defined as low levels of one or more classes \[that is at least 2 standard deviations under the mean level per age\])
* Male or female, ages 2 to 70 years at screening
* Received 200 to 800 mg/kg of a commercially available IVIg therapy in the range of 21- or 28-day intervals (±3 days or ±4 days, respectively) for at least 3 infusion cycles prior to screening
* At least 2 documented IgG trough levels while receiving an IVIg, of greater than or equals to (\>=) 6 gram per liter (g/L) obtained at 2 infusion cycles within 12 months (1 must be within 6 months) prior to Informed Consent Form (ICF) signature
* Participant is willing to comply all requirements of the protocol.
* Females of child-bearing potential with a negative urine pregnancy test and who agree to employ adequate birth control measures during the study
* Authorization to access personal health information
* Participant previously participating in a clinical trial with another experimental IVIg may be enrolled if they have received stable commercially available IVIg therapy for at least 3 infusion cycles (21 or 28 days) prior to screening
* Participant currently on treatment with any subcutaneous immunoglobulin (SCIG) can be enrolled if they are switched to stable commercially available IVIg therapy for at least 3 infusion cycles (21 or 28 days) prior to screening

Exclusion Criteria:

* Newly diagnosed PID and and naïve to IgG replacement therapy
* Dysgammaglobulinemia (defined as a deficiency in one or more classes of antibodies, but not severe enough to require substitutive therapy) or isolated IgG subclass deficiency or profound primary T-cell deficiency (defined as the absence or severe reduction of T lymphocytes \[CD3+ \<300 cells per cubic millimeter (cell/mm3)\] and an absent or particularly low proliferative response \[10% of the lower normal range\] to phytohaemagglutinin P \[PHA\])
* Has history of severe or serious reactions or hypersensitivity to IVIg or other injectable forms of IgG
* Has history of thrombotic events (including deep vein thrombosis, cerebrovascular accident, pulmonary embolism, transient ischemic attacks, or myocardial infarction), as defined by at least 1 event in participant's lifetime
* Has IgA deficiency with documented antibodies to IgA
* Have received blood products that have not undergone viral inactivation measures within 12 months prior to Informed Consent Form (ICF) signature
* Has significant protein losing enteropathy, nephrotic syndrome, or lymphangiectasia
* Has an acute infection as documented by culture or diagnostic imaging and/or a body temperature \>= 38 degree Celsius (°C) (\>=100.4 degree Fahrenheit (°F) within 7 days prior to screening
* Has acquired immunodeficiency syndrome (AIDS) and/or hepatitis B/C active disease at ICF signature
* Has levels of Alanine aminotransferase (ALT) or aspartate aminotransferase (AST), 2.5 times of the upper limit of normal for the laboratory designated for the study
* Using an implanted venous access device
* Has profound anemia (haemoglobin less than10 gram per deciliter \[g/dl\]) or persistent severe neutropenia (\<= 1000 neutrophils per millimeter cube (mm\^3) or lymphopenia of less than 500 cells per microliter
* Have severe chronic condition such as renal failure (creatinine concentration \> 2.0 times the upper limit of normal) with proteinuria, congestive heart failure (New York Heart Association III/IV), cardiomyopathy, cardiac arrhythmia associated with thromboembolic events (e.g., atrial fibrillation), unstable or advanced ischemic heart disease, hyper viscosity, or any other condition that the Investigator believes is likely to interfere with evaluation of the study drug or with satisfactory conduct of the trial. Normal values for serum creatinine are the following: a) Female (18+ years): 45 - 84 micromole per liter (mcmol/L) or 0.51 - 0.95 milligrams per deciliter (mg/dl); b) Male (18+ years): 59 - 103 mcmol/L or 0.67 - 1.17 mg/dl
* Has history of a malignant disease other than properly treated carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin within 24 months prior to ICF signature
* Has history of pharmacoresistant epilepsy or multiple episodes of migraine (defined as at least 1 episode within 6 months of ICF signature) not completely controlled by medication
* Participants must not be receiving steroids (oral or parenteral daily dose of \>= 0.15 milligram per kilogram per day (mg/kg/day) of prednisone or equivalent) or other immunosuppressive drugs or chemotherapy
* Females who are pregnant, breast feeding or planning a pregnancy during the course of the study. Women who become pregnant during the study will be withdrawn from the study
* Has participated in another clinical study within 3 weeks prior to study ICF signature
* Has history of drug or alcohol abuse within the 6 months before screening
* Has Employed or a direct relative of an employee of the CRO, the study site, or the Sponsor
* Previously treated under this protocol
* Unable to provide informed consent or provide informed consent by a legally authorized representative

Primary outcomes:
measure: Incidence Rate of Acute Serious Bacterial Infections (ABSIs)
timeFrame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
Secondary outcomes:
measure: Serum Immunoglobulin G (IgG) Trough Levels
timeFrame: At baseline, Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
measure: Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4)
timeFrame: At baseline, Weeks 16, 32 and 48 (28-day dosing schedule); Weeks 18, 30, 48 (21-day dosing schedule)
measure: Number of Participants With Total Immunoglobulin G (IgG) Trough Levels Less Than or Equal to (<=) 6 Grams/Liter (g/L) Criteria
timeFrame: Up to 12 months
measure: Anti-Tetanus Toxoid Antibody Levels
timeFrame: Baseline, Weeks 16, 32 and 48 (28-day dosing schedule); Weeks 18, 30, 48 (21-day dosing schedule)
measure: Anti-Pneumococcal Capsular Polysaccharide Antibody Levels
timeFrame: Baseline, Weeks 16, 32 and 48 (28-day dosing schedule); Weeks 18, 30, 48 (21-day dosing schedule)
measure: Anti-Measles Antibody Levels
timeFrame: Baseline, Weeks 16, 32 and 48 (28-day dosing schedule); Weeks 18, 30, 48 (21-day dosing schedule)
measure: Anti-Haemophilus Influenza Type B Antibody Levels
timeFrame: Baseline, Weeks 16, 32 and 48 (28 -day dosing schedule); Weeks 18, 30, 48 (21-day dosing schedule)
measure: Incidence Rate of Any Infection Other Than Acute Serious Bacterial Infections
timeFrame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
measure: Duration of Any Infection Other Than Acute Serious Bacterial Infections
timeFrame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
measure: Incidence Rate of Fever Episodes
timeFrame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
measure: Duration of Fever Episodes in Participants
timeFrame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
measure: Duration of Overall Participants Hospitalization
timeFrame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
measure: Duration of Participants Hospitalization Due to Infection
timeFrame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
measure: Incidence Rate of Antibiotics Episodes for Treatment of Any Kind of Infections
timeFrame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
measure: Duration of Participants on Antibiotics for Treatment of Any Kind of Infection
timeFrame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
measure: Duration of Missed School/Work/Other Major Activities Due to Infections
timeFrame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
measure: Pediatric Quality of Life Inventory (PedsQL) Score
timeFrame: Baseline, Week 24 (21-day dosing schedule and 28-day dosing schedule), Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
timeFrame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
measure: Number of TEAEs and Serious TEAEs
timeFrame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
measure: Number of Drug Related Infusion Adverse Events (AEs)
timeFrame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
measure: Percentage of Participants Who Experienced at Least One Drug Related Infusion Adverse Events (AEs)
timeFrame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
measure: Number of Infusions With Decreased Infusion Rate Due to Adverse Events (AEs)
timeFrame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
measure: Number of Infusions With One or More Infusion Associated Adverse Events (AEs)
timeFrame: Baseline up to Week 52
measure: Number of Participants With Clinically Significant Changes From Baseline in Vital Signs
timeFrame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
measure: Number of Participants With Clinically Significant Changes From Baseline in Physical Examinations
timeFrame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
measure: Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters
timeFrame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)
measure: Number of Participants With Positive Coomb's Test at Week 16 (28-day Dosing Schedule) and Week 18 (21-day Dosing Schedule)
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule)
measure: Number of Participants With Positive Urine Hemosiderin Test
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule)
measure: Number of Participants With Abnormal Plasma-free Haemoglobin Level
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule)
measure: Number of Participants With Abnormal Serum Haptoglobin Level
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule)
measure: Maximum Observed Serum Concentration (Cmax) of Total Immunoglobulin G (IgG)
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Elimination Half-Life (t1/2) of Total IgG
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Total IgG
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Total IgG
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Total IgG
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Volume of Distribution (Vd) of Total IgG
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Steady State Clearance (CLss) of Total IgG
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Minimum Observed Serum Concentration (Cmin) of Total IgG
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Time to Reach the Maximum Serum Concentration (Tmax) of Total IgG
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Elimination Rate Constant (Kel) of Total IgG
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Average Concentration of Total IgG Over the Dosing Interval (Cavg)
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Percentage Peak Trough Fluctuation of Total IgG
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Maximum Observed Serum Concentration (Cmax) of Antigen-Specific Tetanus Toxoid Antibodies
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Elimination Half-Life (t1/2) of Antigen-Specific Tetanus Toxoid Antibodies
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Antigen-Specific Tetanus Toxoid Antibodies
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Antigen-Specific Tetanus Toxoid Antibodies
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Antigen-Specific Tetanus Toxoid Antibodies
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Volume of Distribution (Vd) of Antigen-Specific Tetanus Toxoid Antibodies
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Steady State Clearance (CLss) of Antigen-Specific Tetanus Toxoid Antibodies
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Minimum Observed Serum Concentration (Cmin) of Antigen-Specific Tetanus Toxoid Antibodies
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Time to Reach the Maximum Serum Concentration (Tmax) of Antigen-Specific Tetanus Toxoid Antibodies
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Elimination Rate Constant (Kel) of Antigen-Specific Tetanus Toxoid Antibodies
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Average Concentration of Antigen-Specific Tetanus Toxoid Antibodies Over the Dosing Interval (Cavg)
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Percentage Peak Trough Fluctuation of Antigen-Specific Tetanus Toxoid Antibodies
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Maximum Observed Serum Concentration (Cmax) of Antigen-Specific Haemophilus Influenza Type B Antibodies
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Elimination Half-Life (t1/2) of Antigen-Specific Haemophilus Influenza Type B Antibodies
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Antigen-Specific Haemophilus Influenza Type B Antibodies
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Antigen-Specific Haemophilus Influenza Type B Antibodies
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Antigen-Specific Haemophilus Influenza Type B Antibodies
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Volume of Distribution (Vd) of Antigen-Specific Haemophilus Influenza Type B Antibodies
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Steady State Clearance (CLss) of Antigen-Specific Haemophilus Influenza Type B Antibodies
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Minimum Observed Serum Concentration (Cmin) of Antigen-Specific Haemophilus Influenza Type B Antibodies
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Time to Reach the Maximum Serum Concentration (Tmax) of Antigen-Specific Haemophilus Influenza Type B Antibodies
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Terminal Elimination Rate Constant (Lambda z) of Antigen-Specific Haemophilus Influenza Type B Antibodies
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Average Concentration of Antigen-Specific Haemophilus Influenza Type B Antibodies Over the Dosing Interval (Cavg)
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Percentage Peak Trough Fluctuation of Antigen-Specific Haemophilus Influenza Type B Antibodies
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Volume of Distribution (Vd) of of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Steady State Clearance (CLss) of Anti-pneumococcal Capsular Polysaccharide Antibodies (Overall SP Serotypes)
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes)
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
measure: Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes)
timeFrame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion
Other outcomes:
Locations:
city: North Palm Beach
country: United States
facility: Allergy Associates of the Palm Beaches
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Overland Park
country: United States
facility: Dr. Henry J. Kanarek - Allergy, Asthma & Immunology
state: Kansas
city: Plymouth
country: United States
facility: Midwest Immunology Clinic and Infusion Center
state: Minnesota
city: Little Silver
country: United States
facility: Allergy and Immunology Associates
state: New Jersey
city: Buffalo
country: United States
facility: University of Buffalo
state: New York
city: Columbus
country: United States
facility: Optimed Research
state: Ohio
city: Mayfield Heights
country: United States
facility: Ohio Clinical Research Associates, Inc.
state: Ohio
city: Toledo
country: United States
facility: Toledo Institute of Clinical Research Inc
state: Ohio
city: Dallas
country: United States
facility: Allergy Partners of North Texas Research
state: Texas
city: Dallas
country: United States
facility: AARA Research Center
state: Texas
Study officials:
affiliation: Kedrion SpA
name: Medical Director
role: PRINCIPAL_INVESTIGATOR
References: