Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_4

Timeline

Completed

Started Mar 2007

Geographic Reach

4 countries

6 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.6 years study duration

Study Start

First participant enrolled

March 1, 2007

Completed

6 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2007

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed

4.6 years until next milestone

Results Posted

Study results publicly available

May 3, 2013

Completed

Last Updated

June 20, 2013

Status Verified

June 1, 2013

Enrollment Period

1.6 years

First QC Date

August 23, 2007

Results QC Date

March 18, 2013

Last Update Submit

June 12, 2013

Conditions

Common Variable Immunodeficiency Agammaglobulinemia

Keywords

Previously Untreated Patient (PUP)Primary Immunodeficiency (PID)CVIDXLASubcutaneous immunoglobulin (SCIG)IgG trough levelQuality of lifeCommon variable immunodeficiency (CVID)X-linked agammaglobulinemia (XLA)

Outcome Measures

Primary Outcomes (1)

Proportion of Patients Achieving Immunoglobulin G (IgG) Levels ≥ 5 g/L on Day 12
On Day 12

Secondary Outcomes (19)

Proportion of Patients Achieving IgG Levels ≥ 5 g/L on Day 19
On Day 19
Proportion of Patients Achieving IgG Levels ≥ 5 g/L on Day 26
On Day 26
IgG Increase (Change From Baseline) on Day 12
Baseline to Day 12
Overall Rate of Infections
For the duration of the study, up to approximately 25 weeks
Total Serum IgG Trough Levels on Day 12
On Day 12
+14 more secondary outcomes

Study Arms (1)

Vivaglobin

EXPERIMENTAL

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.

Drug: Vivaglobin

Interventions

VivaglobinDRUG

Human normal immunoglobulin G (IgG) for subcutaneous (SC) use.

Vivaglobin

Eligibility Criteria

Age1 Year - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.