primary immunodeficiency disease (PID) MedDRA version: 14.1 Level: LLT Classification code 10049485 Term: Bruton's agammaglobulinemia System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1 Level: LLT Classification code 10010112 Term: Common variable immunodeficiency System Organ Class: 10021428 - Immune system disorders
Conditions
Interventions
Trade Name: OCTAGAM 50 mg/ml oldatos infúzió
Product Name: Octagam 5%
Pharmaceutical Form: Solution for infusion
CAS Number: 308067-58-5
Current Sponsor code: Octagam 5%
Other descriptive name: IMMUNO
Sponsors
OCTAPHARMA AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age of >= 18 years and =65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: 8. Acute infection requiring intravenous antibiotic treatment within 2 weeks prior to and during the screening period. 9. Known history of adverse reactions to IgA in other products. 10. Exposure to blood or any blood product or derivative, other than commercially available IVIG, within the past 3 months prior to enrolment. 11. Ongoing history of hypersensitivity or persistent reactions to blood or plasma derived products, or any component of the investigational product. 12. Requirement of any routine premedication for IVIG infusion. 13. History of congenital impairment of pulmonary function. 14. Severe liver function impairment 15. Presence of renal function impairment, or predisposition for acute renal failure. 16. History of autoimmune haemolytic anaemia. 17. History of diabetes mellitus. 18. Congestive heart failure NYHA class III or IV. 19. Non-controlled arterial hypertension. 20. History of deep vein thrombosis or thrombotic complications of IVIG therapy. 21. Known HIV, HCV, or HBV infection. 22. Presence of any clinically relevant disease or unstable condition at screening, other than PID, which in the opinion of the Investigator could interfere with the conduct of the study. 23. Treatment with steroids , immunosuppressive or immunomodulatory drugs. 24. Planned vaccination during the study period except for “killed” influenza vaccines (incl. H1N1). 25. Participating in another clinical trial or planned participation in another trial for the duration of this study. 26. Treatment with any investigational agent within 3 months prior to enrolment. 27. Known or suspected to abuse alcohol, drugs, psychotropic agents or other chemicals within the past 12 months prior to enrolment. 28. Pregnant or nursing women. 29. Unable or unwilling to comply with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the pharmacokinetic (PK) profile of Octagam 5% at steady state on standard prophylactic treatment of Primary Immunodeficiency Disorders (PID).;Secondary Objective: • To evaluate the efficacy of Octagam 5% in preventing serious bacterial infections compared to historical control data. • To evaluate safety and tolerability of Octagam 5%. ;Primary end point(s): PK profile of Octagam with respect to total IgG, IgG subclasses (IgG1, IgG2, IgG3, IgG4), and antigen-specific antibodies at steady state on standard prophylactic treatment of PID;Timepoint(s) of evaluation of this end point: continuously, see protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Trough levels of serum total IgG. • Rate of serious bacterial infections (defined as bacteraemia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, and visceral abscess) per person-year on treatment. • The occurrence of all infections of any kind or seriousness. • Non-serious infections (total and by category). • Time to resolution of infections. • Use of antibiotics. • Hospitalisations due to infection. • Episodes of fever. • Days missed from school or work due to infections and their treatment. • Occurrence of AEs. • Occurrence of temporally associated AEs. • Proportion of infusions with 1 or more temporally associated AEs. • AEs by infusion rate. • Short term tolerance parameters including vital signs (blood pressure, heart rate, temperature, respiratory rate). • Laboratory parameters (haematology, clinical chemistry, and urinalysis). ;Timepoint(s) of evaluation of this end point: continuously, see protocol | — |
Countries
Czech Republic, Germany, Hungary
Contacts
Public ContactClinical Research Department
Octapharma Pharmazeutika Produktionsgesellschaft
Outcome results
None listed