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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00719680 |
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Date of registration:
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21/07/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Extension Study of Subcutaneous Immunoglobulin Human in Patients With Primary Immunodeficiency (PID)
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Scientific title:
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A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency (PID) |
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Date of first enrolment:
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June 2008 |
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Target sample size:
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21 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00719680 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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United States
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Contacts
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Name:
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Program Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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CSL Behring |
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Key inclusion & exclusion criteria
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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
Age minimum:
2 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Primary Immune Deficiency
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Intervention(s)
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Biological: IgPro20
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Primary Outcome(s)
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Annualized Rate of Serious Bacterial Infection (Intention-to-Treat Population)
[Time Frame: For the duration of the study, up to approximately 104 weeks]
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Annualized Rate of Serious Bacterial Infection (Per-Protocol Efficacy Population)
[Time Frame: For the duration of the study, up to approximately 104 weeks]
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Secondary Outcome(s)
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Rate of Temporally Associated AEs Within 24 or 72 Hours of an Infusion
[Time Frame: Within 24 or 72 hours after each infusion]
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Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Vital Signs
[Time Frame: At weeks 1, 12, 24, 36, 48, 60, 72, 84, and 96]
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Number of Days of Hospitalization Due to Infection
[Time Frame: For the duration of the study, up to approximately 104 weeks]
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Use of Antibiotics for Infection Prophylaxis and Treatment
[Time Frame: For the duration of the study, up to approximately 104 weeks]
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Annualized Rate of Hospitalization Due to Infection
[Time Frame: For the duration of the study, up to approximately 104 weeks]
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Annualized Rate of Any Infection
[Time Frame: For the duration of the study, up to approximately 104 weeks]
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Number of Subjects Reporting Mild, Moderate, or Severe Local AEs
[Time Frame: For the duration of the study, up to approximately 104 weeks]
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Rate of All AEs by Relatedness and Severity
[Time Frame: For the duration of the study, up to approximately 104 weeks]
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Trough Levels of Total Immunoglobulin G (IgG) Serum Concentrations
[Time Frame: Before infusion at Weeks 1, 24, 48, 72, and 96]
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Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Viral Safety Markers
[Time Frame: At Week 1, and study completion (approximately 104 weeks)]
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Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Infection
[Time Frame: For the duration of the study, up to approximately 104 weeks]
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Number of Subjects With Any Temporally Associated Adverse Event (AE) Within 24 or 72 Hours After an Infusion
[Time Frame: Within 24 or 72 hours after each infusion]
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Relatedness and Severity of All AEs (Percentage of Total AEs)
[Time Frame: For the duration of the study, up to approximately 104 weeks]
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Number of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Infection
[Time Frame: For the duration of the study, up to approximately 104 weeks]
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Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Routine Laboratory Parameters
[Time Frame: At Week 1, and study completion (approximately 104 weeks)]
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Secondary ID(s)
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IgPro20_3001
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1473
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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