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

CSL Behring

Status and phase: Completed; Phase 3

Conditions: Primary Immune Deficiency

Treatments: Biological: IgPro20

Study type: Interventional

Funder types: Industry

Identifiers

NCT00719680

1473 (Other Identifier)

IgPro20_3001

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 2 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

IgPro20

Experimental group

Description:

The IgPro20 dose will be the same as in the previous pivotal study ZLB04_009CR (NCT00419341) infused subcutaneously weekly or twice a week (in the latter case, half of a weekly dose will be used)

Treatment:

Biological: IgPro20