Trials / Completed
CompletedNCT02638207
Study to Evaluate Safety and Efficacy of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly (Radiculo) Neuropathy
Prospective, Double-blind, Randomized, Multicenter Phase III Study Evaluating Efficacy and Safety of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly(Radiculo)Neuropathy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 142 (actual)
- Sponsor
- Octapharma · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
Study to evaluate the Efficacy and Safety of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly(radiculo)neuropathy
Detailed description
Prospective, Double-blind, Randomized, Multicenter Phase III Study Evaluating Efficacy and Safety of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly(radiculo)neuropathy ("ProCID trial")
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NewGam | In the Dose-evaluation Phase, all patients will receive a loading dose of 2.0 g/kg Newgam (administered over two consecutive days), followed by seven infusions of the maintenance dose the patient has been randomized to (0.5, 1.0 or 2.0 g/kg NewGam), also administered over two consecutive days every 3 weeks (±4 days). If a patient is randomized to receive the low or medium NewGam dose, the same volume with the same infusion rate as would have been applied in case the patient would have been randomized to 2.0 g/kg NewGam will be used, thus supplemented with an authorized 0.9% w/v isotonic sodium chloride solution as appropriate and detailed in the following infusion bag split to maintain the blinding |
Timeline
- Start date
- 2017-09-27
- Primary completion
- 2019-09-05
- Completion
- 2019-09-05
- First posted
- 2015-12-23
- Last updated
- 2021-02-16
- Results posted
- 2021-02-16
Locations
26 sites across 9 countries: Bulgaria, Canada, Czechia, Germany, Hungary, Poland, Romania, Russia, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02638207. Inclusion in this directory is not an endorsement.