Treatment in patients with recurrent infections and IgG Subclass Deficiency, and/or Deficient Anti-Polysaccharide Antibody Response.

Phase 4

Completed

• Conditions: antibody deficiency; 10021460; 10024970

• Registration Number: NL-OMON35384
• Lead Sponsor: Sanquin Plasmaproducten

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

IgG subclass deficiency and/or (selective) antipolysaccharide antibody deficiency, and at least 2 physician documented infections before the start of the current treatment or in the last 6 months for newly diagnosed patients.

Exclusion Criteria

- Treatment with any other investigational drug within 7 days prior to study entry, or previous enrolment in this study
- Allergic reactions against human plasma/plasma products, or co-trimoxazol
- An ongoing progressive terminal disease
- Pregnancy or lactation
- Renal insufficiency (plasma creatinin > 115 µmol/L; or creatinin clearance <20 ml/min))
- An ongoing active disease causing general symptoms e.g. chronic active hepatitis or persistent enterovirus infection with ongoing systemic complaints
- Detectable anti-IgA antibodies
- Active SLE
- Glucose-6-phosphate hydrogenase deficiency

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary clinical efficacy parameters are: the number, duration and type of<br /><br>infection (including use of antibiotics to treat infections), days of fever,<br /><br>hospital admissions and, if applicable, days absent from school or work due to<br /><br>infections.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Safety will be monitored by occurrence of adverse events, vital signs, and<br /><br>laboratory measurements. </p><br>