Extension Study of Subcutaneous Immunoglobulin Human in Patients With Primary Immunodeficiency (PID)

Primary Immune Deficiency Clinical Trial

Official title:

A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency (PID)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00719680
• Other study ID #: IgPro20_3001
• Secondary ID: 1473
• Status: Completed
• Phase: Phase 3
• First received: July 21, 2008
• Last updated: March 5, 2014
• Start date: June 2008
• Est. completion date: June 2010

Study information

• Verified date: December 2012
• Source: CSL Behring
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether a long-term use of a new human immunoglobulin G with proline (IgPro) is safe and effective in the treatment of primary immunodeficiency.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 75 Years

Eligibility

Inclusion Criteria:

• Subjects with primary humoral immunodeficiency who have participated in the study ZLB04_009CR (NCT00419341), namely with a diagnosis of Common Variable Immunodeficiency (CVID) as defined by PAGID (Pan-American Group for Immunodeficiency) and ESID (European Society for Immunodeficiencies) or X-linked Agammaglobulinemia (XLA) as defined by PAGID and ESID

• Women of childbearing potential must be using and agree to continue using medically approved contraception and must have a negative pregnancy test at screening

• Written informed consent

Exclusion Criteria:

• Ongoing serious bacterial infection at the time of screening

• Malignancies of lymphoid cells such as lymphocytic leukemia, Non-Hodgkin's lymphoma, and immunodeficiency with thymoma

• Hypoalbuminemia, protein-losing enteropathies, and any proteinuria (defined by total urine protein concentration > 0.2 g/L)

• Other significant medical conditions that could increase the risk to the patient

• Females who are pregnant, breast-feeding or planning a pregnancy during the course of the study

• A positive result at screening on any of the following viral markers: Human immunodeficiency virus (HIV), Hepatitis C virus (HCV) or Hepatitis B virus (HBV)

• Aspartate aminotransferase (ASAT) or Alanine aminotransferase (ALAT) concentration > 2.5 times Upper Normal Limit (UNL) at Completion Visit of study ZLB04_009CR (NCT00419341)

• Creatinine concentration > 1.5 times UNL at Completion Visit of study ZLB04_009CR (NCT00419341)

• Participation in a study with an investigational product other than IgPro20 within 3 months prior to enrollment

• Evidence of uncooperative attitude

• Any condition that is likely to interfere with evaluation of the study drug or satisfactory conduct of the trial

• Subjects who are employees at the investigational site, relatives or spouse of the investigator

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Immunologic Deficiency Syndromes
• Primary Immune Deficiency

Intervention

Biological:
• IgPro20

Locations

Country	Name	City	State
United States	Contact CSL Behring for facility details	Centennial	Colorado
United States	Contact CSL Behring for facility details	Dallas	Texas
United States	Contact CSL Behring for facility details	Indianapolis	Indiana
United States	Contact CSL Behring for facility details	North Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
CSL Behring

Country where clinical trial is conducted

United States, 

References & Publications (1)

Jolles S, Borte M, Nelson RP Jr, Rojavin M, Bexon M, Lawo JP, Wasserman RL. Long-term efficacy, safety, and tolerability of Hizentra® for treatment of primary immunodeficiency disease. Clin Immunol. 2014 Feb;150(2):161-9. doi: 10.1016/j.clim.2013.10.008. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annualized Rate of Serious Bacterial Infection (Intention-to-Treat Population)	The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.; Acute serious bacterial infections included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess.	For the duration of the study, up to approximately 104 weeks	No
Primary	Annualized Rate of Serious Bacterial Infection (Per-Protocol Efficacy Population)	The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.; Acute serious bacterial infections included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess.	For the duration of the study, up to approximately 104 weeks	No
Secondary	Annualized Rate of Any Infection	The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.	For the duration of the study, up to approximately 104 weeks	No
Secondary	Trough Levels of Total Immunoglobulin G (IgG) Serum Concentrations	Mean of individual median total IgG trough concentration.	Before infusion at Weeks 1, 24, 48, 72, and 96	No
Secondary	Number of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Infection		For the duration of the study, up to approximately 104 weeks	No
Secondary	Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Infection	The annualized rate was based on the total number of days out of work / school / kindergarten / day care or inability to perform normal activities due to infection, and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.	For the duration of the study, up to approximately 104 weeks	No
Secondary	Number of Days of Hospitalization Due to Infection		For the duration of the study, up to approximately 104 weeks	No
Secondary	Annualized Rate of Hospitalization Due to Infection	The annualized rate was based on the total number of days of hospitalization due to infection and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.	For the duration of the study, up to approximately 104 weeks	No
Secondary	Use of Antibiotics for Infection Prophylaxis and Treatment	Annualized rate of days with antibiotics for infection prophylaxis and treatment.	For the duration of the study, up to approximately 104 weeks	No
Secondary	Rate of All AEs by Relatedness and Severity	The rate of AEs was the number of AEs over the number of infusions administered.; At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.; Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities.	For the duration of the study, up to approximately 104 weeks	Yes
Secondary	Relatedness and Severity of All AEs (Percentage of Total AEs)	At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.; Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities.	For the duration of the study, up to approximately 104 weeks	Yes
Secondary	Number of Subjects With Any Temporally Associated Adverse Event (AE) Within 24 or 72 Hours After an Infusion	AEs were considered temporally associated if they occurred between the start of infusion and within 24 or 72 hours after the end of infusion.	Within 24 or 72 hours after each infusion	Yes
Secondary	Rate of Temporally Associated AEs Within 24 or 72 Hours of an Infusion	The rate of AEs was the number of AEs over the number of infusions administered.; AEs were considered temporally associated if they occurred between the start of infusion and within 24 or 72 hours after the end of infusion.	Within 24 or 72 hours after each infusion	Yes
Secondary	Number of Subjects Reporting Mild, Moderate, or Severe Local AEs	In addition to the standard MedDRA System Organ Class (SOC) AE assignments, the category of 'local reactions' was defined to provide the possibility for a combined analysis of local reactions and included AEs of infusion site oedema, infusion site reaction, injection site pain, injection site rash, and injection site reaction.; Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities.	For the duration of the study, up to approximately 104 weeks	Yes
Secondary	Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Vital Signs	Vital signs included blood pressure (systolic and diastolic), heart rate, and body temperature.	At weeks 1, 12, 24, 36, 48, 60, 72, 84, and 96	Yes
Secondary	Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Routine Laboratory Parameters	Routine laboratory parameters included hematology, blood chemistry, and urinalysis parameters.	At Week 1, and study completion (approximately 104 weeks)	Yes
Secondary	Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Viral Safety Markers	Viral safety markers included human immunodeficiency virus (HIV)-1, HIV-2, hepatitis A virus (HAV), HBV, HCV, and parvovirus B19.	At Week 1, and study completion (approximately 104 weeks)	Yes

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