drugset / Trial / NCT04589299
Subcutaneous Immunoglobulin in De-novo CIDP (SIDEC)
Phase 4
Recruiting
60 enrolled
University of Aarhus
Aalborg University Hospital · collabAarhus University Hospital · collabOdense University Hospital · collabRigshospitalet, Denmark · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
SIDEC - (Subcutaneous Immunoglobulin in De-novo CIDP) ia a study designed as a randomized, parallel study with an open-label extension phase. The aims are to compare the effect of SCIG and IVIG in 60 treatment-naïve CIDP patients, and to detect the lowest effective dosage for maintenance treatment.
Timeline
- Start
- 2020-06-04
- Primary completion
- 2030-12-31
- Completion
- 2030-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 0.54 g/kg | Intravenous |
| Comparator | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 2 g/kg | Intravenous |