Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00278954
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2006-01-18
Brief Title:
Efficacy Safety and Pharmacokinetics of Gammaplex in Primary Immunodeficiency Diseases
Sponsor:
Bio Products Laboratory
Organization:
Bio Products Laboratory
Study Overview
Official Title:
A Phase III Multicenter Open-Label Study To Evaluate The Efficacy Safety and Pharmacokinetics of Gammaplex in Primary Immunodeficiency Diseases
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main objective of this study is to see if GAMMAPLEX is efficacious with respect to Food and Drug Administration FDA minimal requirements no more than 1 serious acute bacterial infection per subject per year in subjects with Primary Immunodeficiency Diseases PID The secondary objectives are to assess the safety and tolerability of GAMMAPLEX and to determine if GAMMAPLEX has a pharmacokinetic PK profile comparable with that of intact Immunoglobulin G IgG in subjects with PID
Detailed Description:
Primary Efficacy Variable The primary variable is the number of serious acute bacterial infectionssubjectyear and it will be based on the total of all of the following events as defined by the FDA bacterial Pneumonia bacteremiasepsis osteomyelitisseptic arthritis visceral abscess and bacterial meningitis
Secondary Efficacy Variables Secondary efficacy will be determined by using the following variables number of days of workschool missed because of infection per subject year number and days of hospitalizations because of infection per subject year number of visits to physicians for acute problems andor number of visits to hospital emergency rooms per subject year other infections documented by fever or a positive result on a radiograph andor culture number of infectious episodes per subject per year number of days on therapeutic antibioticsThese data will be entered into the subject diary confirmed by the physician and entered on the electronic-CRF e-CRF
Safety Variables The variables used to assess safety will be the following adverse events AEs vital signs clinical laboratory tests and Direct Coombs Test transmission of viruses physical examination
Test product dosemode of administration batch numbers The GAMMAPLEX dose is 300-800 mgkginfusion milligram per killgram per infusion every 21 or 28 days intravenously At least 2 batches will be used in this study and no more than 1 batch in any given infusion
Duration of treatment
The total duration of treatment is 12 months
Secondary Efficacy Variables Secondary efficacy will be determined by using the following variables number of days of workschool missed because of infection per subject year number and days of hospitalizations because of infection per subject year number of visits to physicians for acute problems andor number of visits to hospital emergency rooms per subject year other infections documented by fever or a positive result on a radiograph andor culture number of infectious episodes per subject per year number of days on therapeutic antibioticsThese data will be entered into the subject diary confirmed by the physician and entered on the electronic-CRF e-CRF
Safety Variables The variables used to assess safety will be the following adverse events AEs vital signs clinical laboratory tests and Direct Coombs Test transmission of viruses physical examination
Test product dosemode of administration batch numbers The GAMMAPLEX dose is 300-800 mgkginfusion milligram per killgram per infusion every 21 or 28 days intravenously At least 2 batches will be used in this study and no more than 1 batch in any given infusion
Duration of treatment
The total duration of treatment is 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None