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Oral immunoglobulin for treatment of children with active Crohn's disease
2004-005016-93Phase 4
Key facts
- Status
- Active
- Start
- Dec 2004
- Countries
- 1
- Sponsor
- Vrinnevi Hospital
- Modality
- Recombinant Proteins and Enzymes
- Conditions
- Crohn's disease
01
Overview
Phase 4, single-arm trial of Human normal immunoglobulin G in Crohn's disease, sponsored by Vrinnevi Hospital. Primary endpoint: Efficacy of oral immunoglobulin in active Crohn's disease. Started Dec 2004; status: active.
02
Design
1 arm- Study design
- Non-randomizedSingle group
Polyglobin oral immunoglobulin
Children with active Crohn's disease receive oral Polyglobin 10% as monotherapy; efficacy and tolerability are assessed.
03
Who it enrols
Children under 18 years of age with active Crohn's disease who are able to adhere to the treatment protocol and attend scheduled hospital visits.
04
Endpoints
Primary
Efficacy of oral immunoglobulin in active Crohn's disease
Secondary
Tolerability of oral immunoglobulin in active Crohn's disease
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