Efficacy, Safety and Kinetics Study of Octagam 10% in Primary Immunodeficiency Diseases

Octapharma

Status and phase

Terminated

Phase 3

Conditions

Immunologic Deficiency Syndromes

Treatments

Drug: Octagam 10%

Study type

Interventional

Funder types

Industry

Identifiers

NCT00811174

GAM10-03

Details and patient eligibility

About

Octagam is a human normal immunoglobulin (IGIV) solution for intravenous administration. Octagam 5% is currently registered in more than 60 countries. This study will evaluate the efficacy, safety and the kinetics of Octagam 10% for replacement therapy in primary immunodeficiency diseases.

Full description

The primary objective of the study is to investigate the safety of Octagam 10% in replacement therapy in PID and to compare the pharmacokinetic profile of Octagam 10% with that of the previously used Octagam 5%.

The secondary objective is to investigate the efficacy of Octagam 10% in replacement therapy in PID by monitoring the rate of occurence of serious bacterial infections, the rate of other infections, the trough (pre-next-dose) levels of total serum IgG and IgG subclasses (IgG1, IgG2, IgG3 and IgG4), the trough (pre-next-dose) levels of selected antigen specific antibodies, the use of antibiotics, the rate of absence from school/ work, and the number of days in hospital.

Enrollment

5 patients

Sex

All

Ages

2 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Confirmed diagnosis of primary immunodeficiency (acc. WHO)
Previous treatment with commercial Octagam 5% every 3-4 weeks for at least 6 infusions intervals
Documented IgG trough levels of the two previous infusions before enrollment with a value of at least 5.5 g/L for both

Exclusion criteria

Acute infection requiring intravenous antibiotic treatment within two weeks before screening
Exposure to blood or any blood product or derivative other than commercially available Octagam 5%, within the past 3 months
History of hypersensitivity to blood or plasma derived products
Requirement of any routine premedication for IGIV treatment
History of congenital impairment of pulmonary function
Severe liver function impairment
Severe renal function impairment or predisposition for acute renal failure
History of autoimmune haemolytic anaemia
History of diabetes mellitus
Congestive heart failure NYHA III or IV
Non-controlled arterial hypertension
History of DVT or thrombotic complications with IGIV treatment
Known infection with HIV, HCV or HBV
Treatment with steroids, immunosuppressive or immunomodulatory drugs
Planned vaccination during study period
Pregnant or nursing woman