drugset / Trial / NCT02638207
Study to Evaluate Safety and Efficacy of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly (Radiculo) Neuropathy
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Study to evaluate the Efficacy and Safety of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly(radiculo)neuropathy
Timeline
- Start
- 2017-09-27
- Primary completion
- 2019-09-05
- Completion
- 2019-09-05
Publications
- Bus SR, de Haan RJ, Vermeulen M, van Schaik IN, Eftimov F. Intravenous immunoglobulin for chronic inflammatory demyelinating polyradiculoneuropathy. Cochrane Database Syst Rev. 2024 Feb 14;2(2):CD001797. doi: 10.1002/14651858.CD001797.pub4.
- Cornblath DR, van Doorn PA, Hartung HP, Merkies ISJ, Katzberg HD, Hinterberger D, Clodi E; ProCID Investigators. Safety and Tolerability of Intravenous Immunoglobulin in Chronic Inflammatory Demyelinating Polyneuropathy: Results of the ProCID Study. Drug Saf. 2023 Sep;46(9):835-845. doi: 10.1007/s40264-023-01326-z. Epub 2023 Jun 28.
- Cornblath DR, van Doorn PA, Hartung HP, Merkies ISJ, Katzberg HD, Hinterberger D, Clodi E; ProCID Investigators. Randomized trial of three IVIg doses for treating chronic inflammatory demyelinating polyneuropathy. Brain. 2022 Apr 29;145(3):887-896. doi: 10.1093/brain/awab422.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 0.5 g/kg | Intravenous |
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 1 g/kg | Intravenous |
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 2 g/kg | Intravenous |