EUCTR2007-002611-27-FR
Active, Not Recruiting
Phase 1
Clinical study to evaluate the efficacy, safety and kinetics of Octagam® 10% for replacement therapy in Primary Immunodeficiency Diseases (PID) - NA
ConditionsPrimary Immunodeficiency Diseases (PID)MedDRA version: 9.1Level: LLTClassification code 10064859Term: Primary immunodeficiency syndrome
DrugsOctagam 10%
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Primary Immunodeficiency Diseases (PID)
- Sponsor
- Octapharma AG
- Enrollment
- 5
- Status
- Active, Not Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age of \= 2 years and \= 75 years.
- •For minor patients, above a minimum weight based on the amount of blood
- •required for testing: per individual, the trial\-related blood loss (including any
- •losses in the manoeuvre) should not exceed 3% of the total blood volume during a
- •period of four weeks and should not exceed 1% at any single time (the total
- •volume of blood is estimated at 80 ml/kg body weight).
- •Confirmed diagnosis of primary immunodeficiency as stated by the World Health
- •Organisation and requiring immunoglobulin replacement therapy due to hypogammaglobulinemia or agammaglobulinemia. The exact type
- •of PID should be recorded.
- •Previously treated with commercial Octagam 5% every 21\-28 days for at least 6 infusion intervals at a constant dose between 200\-800 mg/kg body weight
Exclusion Criteria
- •Acute infection requiring intravenous antibiotic treatment within two weeks before
- •Known history of adverse reactions to IgA in other products.
- •Exposure to blood or any blood product or derivative, other than a commercially
- •available Octagam 5%, within the past 3
- •Ongoing history of hypersensitivity or persistent reactions to blood or plasma
- •derived products, or any component of the investigational product, such as
- •Requirement of any routine pre\-medication for IGIV infusion.
- •History of congenital impairment of pulmonary function.
- •Severe liver function impairment (ALAT 3x \> normal value)
- •Severe renal function impairment (creatinine \> 120 µmol/L), or predisposition for
Outcomes
Primary Outcomes
Not specified
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