IPAD Trial
- Conditions
- Primary antibody deficiency:- Unclassified antibody deficiency (unPAD)- IgA deficiency- Specific polysaccharide antibody deficiency (SPAD)- IgG subclass deficiency (IgSD)- Common variable immunodeficiency (CVID)- Agammaglobulinemia (X-linked or otherwise)Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- CTIS2024-513124-41-00
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
Age 8-60 years, Diagnosis of Primary Antibody Deficiency / Common Variable Immunodeficiency Disorder (see Appendix I protocol), Indication for immunoglobulin replacement therapy and/or treated with immunoglobulin replacement therapy, Current IgG dosing 0.25 - 0.6 gr / kg / 3-4 weeks, Receiving treatment and follow-up for PAD by a physician in one of the participating centers, Written informed consent
Diagnosis of Combined Immunodeficiency (CID) disease at onset of study (see Appendix 1). Explanation: Combined Immunodeficiency is featured by the occurrence of more viral infections and reactivations and thus less comparable to PAD., Severe pulmonary disease, determined by an independent radiologist: a.Baseline AD score > 7 and/or ILD score > 5, in combination with: i.Saccular bronchiectasis on CT scan, or; ii.Clinical diagnosis of severe respiratory insufficiency ( (defined as: saturations in room air <92%, and/ or oxygen dependency). b.Baseline pulmonary function (FEV1 and FVC) <70% expected for age and body weight / length), Active smoker
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