CompletedPhase 4

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

Canada, Germany, Italy18 participantsStarted 2007-03

Plain-language 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.

Who can participate

Age range

1 Year – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: On Day 12

Trial details

NCT IDNCT00520494

SponsorCSL Behring

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-10

Results submitted2013-03-18

View on ClinicalTrials.gov More Common Variable Immunodeficiency trials