Clinical study to evaluate the efficacy and safety of Octagam 5% in patients with Primary Immunodeficiency diseases (PID)

Prospective, open-label, non-controlled, multicenter, phase III clinical study to evaluate the pharmacokinetics, safety and efficacy of Octagam 5% in patients with Primary Immunodeficiency Diseases

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN32382999

Enrollment

Registered

2012-10-15

Start date

2012-07-15

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Immunodeficiency diseases (PID) Haematological Disorders Immunodeficiency with predominantly antibody defects, unspecified

Interventions

Two multiple dose intravenous Octagam 5% regimens (every 3 weeks or every 4 weeks, continuing the patient?s pre-study infusion interval) for 6 or 5 Octagam infusions for patients on a 3-week or 4-week

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age between 18 years and 75 years 2. Primary immunodeficiency syndromes with significant component hypogamma-globulinaemia or antibody deficiency 3. Previously treated with a commercial IVIG every 21?28 days for at least 6 infusion intervals at a constant dose between 200 and 800 mg/kg body weight 4. Availability of the IgG trough levels of the 2 previous infusions before enrolment

Exclusion criteria

Exclusion criteria: 1. Acute infection 2. Known history of adverse reactions to IgA in other products 3. Exposure to blood or any blood product, other than commercially available IVIG, within the past 3 months prior to enrolment 4. Congestive heart failure NYHA class III or IV 5. Non-controlled arterial hypertension 6. History of deep vein thrombosis 7. Known HIV, HCV, or HBV infection

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the PK profile of Octagam with respect to total IgG, IgG subclasses	—

Secondary

Measure	Time frame
The following parameters will be used in the safety and tolerability assessment of the treatment: 1. Vital signs 2. Physical examination 3. AEs 4. Laboratory parameters	—

Countries

Czech Republic

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026