Efficacy and Safety of Vivaglobin® in Previously Untreated Patients With Primary Immunodeficiency

CSL Behring

Status and phase: Completed; Phase 4

Conditions: Common Variable Immunodeficiency; Agammaglobulinemia

Treatments: Drug: Vivaglobin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00520494

2006-006522-25 (EudraCT Number)

1461 (Other Identifier)

ZLB06_005CR

Details and patient eligibility

About

The objective of this study is to assess the efficacy and safety of Vivaglobin in previously untreated patients (PUPs) with primary immunodeficiency (PID) over a 25-week observation period. The purpose is to investigate whether PUPs will respond to subcutaneous immunoglobulin (SCIG) treatment with adequate trough levels without first receiving immunoglobulins by the intravenous route by demonstrating that 100 mg immunoglobulin G/kg body weight (IgG/kg bw) administered on 5 consecutive days (i.e. resulting in a total dose of 500 mg IgG/kg bw) results in an IgG increase to ≥ 5 g/L on Day 12 after initiation of SCIG therapy.

Enrollment: 18 patients

Sex: All

Ages: 1 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Written informed consent, age-adapted
• Male or female aged 1 to 70 years
• Diagnosis of primary humoral immunodeficiency
• No prior immunoglobulin substitution therapy
• IgG level of <5 g/L at screening
• Women of childbearing potential must use medically approved contraception and must have a negative urine pregnancy test at screening

Key Exclusion Criteria:

• Evidence of serious infection between screening and first treatment
• Bleeding disorders that require medical treatments
• Any medical disorder causing secondary immune disorders, autoimmune neutropenia, or a clinically significant defect in cell mediated immunity
• Any condition likely to interfere with evaluation of the study drug or satisfactory conduct of the trial

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Vivaglobin

Experimental group

Description:

Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.

Treatment:

Drug: Vivaglobin