Clinical trial to confirm and expand information on absorption, distribution, elimination in the body, efficacy, tolerability and safety of a new drug in patients with impaired immune system.
- Conditions
- Primary immunodeficiencyMedDRA version: 20.0Level: HLTClassification code 10036700Term: Primary immunodeficiency syndromesSystem Organ Class: 100000004870Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2013-003877-87-PL
- Lead Sponsor
- Octapharma Pharmazeutika Prod.Ges.m.b.H
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 64
1. Age of =2 years and =75 years.
2. Confirmed diagnosis of PI as defined by ESID and PAGID and requiring immunoglobulin replacement therapy due to hypogammaglobulinaemia or agammaglobulinaemia. The exact type of PI should be recorded.
3. Patients on regular IVIG treatment for at least 6 infusions at a constant dose between 200 and 800 mg/kg body weight (±20% of the mean dose for the last 6 infusions). For a minimum of at least 2 months prior study entry, patients have to be on the same IVIG brand.
4. Availability of the IgG trough levels of 2 previous IVIG infusions before enrolment, and maintenance of =5.0 g/L in the trough levels of these 2 previous infusions.
5. Negative result on a pregnancy test (HCG-based assay in urine) for women of childbearing potential and use of a reliable method of contraception for the duration of the study.
6. For adult patients: freely given written informed consent. For minor patients: freely given written informed consent from parents/legal guardians and written informed assent from the child/adolescent in accordance with the applicable regulatory requirements.
7. Willingness to comply with all aspects of the protocol, including blood sampling, for the duration of the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 36
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8
1.Acute infection requiring intravenous antibiotic treatment within 2 weeks prior to and during the screening period.
2. Known history of adverse reactions to IgA in other products.
3. Patients with body mass index =30 kg/m2.
4. Exposure to blood or any blood product or plasma derivatives, other than IVIG treatment for PID, within the past 3 months prior to first infusion of octanorm.
5. Ongoing history of hypersensitivity or persistent reactions to blood or plasma derived products, or any component of the investigational product (such as polysorbate 80).
6. Requirement of any routine premedication for IgG administration.
7. History of malignancies of lymphoid cells and immunodeficiency with lymphoma.
8. Severe liver function impairment (ALAT 3 times above upper limit of normal).
9. Known protein-losing enteropathies or proteinuria.
10. Presence of renal function impairment (creatinine >120 µM/L or creatinine >1,35 mg/dL), or predisposition for acute renal failure (e.g., any degree of pre-existing renal insufficiency or routine treatment with known nephritic drugs).
11. Treatment with oral or parenteral steroids for =30 days or when given intermittently or as bolus at daily doses =0.15 mg/kg.
12. Treatment with immunosuppressive or immunomodulatory drugs.
13. Live viral vaccination (such as measles, rubella, mumps and varicella) within the last 2 months prior to first infusion of octanorm.
14. Treatment with any investigational medicinal product within 3 months prior to first infusion of octanorm.
15. Presence of any condition, that is likely to interfere with the evaluation of study medication or satisfactory conduct of the trial.
16. Known or suspected to abuse alcohol, drugs, psychotropic agents or other chemicals within the past 12 months prior to first infusion of octanorm.
17. Known or suspected HIV, HCV, or HBV infection.
18. Pregnant or nursing women.
19. Planned pregnancy during course of the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method