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POINT: NewGam (Panzyga) in CIDP
NCT01225276Phase 3
Key facts
- Status
- Terminated
- Start
- Oct 2011
- Primary completion
- Oct 2012
- Sponsor
- Octapharma
- Modality
- Recombinant Proteins and Enzymes
- Conditions
- chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
01
Overview
Phase 3, randomised, double-blind trial of intravenous immunoglobulin G in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) (4 arms), sponsored by Octapharma. Primary endpoint: Adjusted INCAT disability score. Started Oct 2011; status: terminated.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Dosage Arm 1
NewGam 10% 0.4 g/kg (Loading 2.0 g/kg)
Dosage Arm 2
NewGam 10% 1.0 g/kg (Loading 2.0 g/kg)
Dosage Arm 3
NewGam 10% 2.0 g/kg (Loading 2.0 g/kg)
Placebo Arm
Placebo 0.9% Saline
03
Who it enrols
Adult patients with confirmed CIDP (INCAT criteria) and worsening disability. Excludes patients with unifocal/pure sensory CIDP, MMN, prior immunoglobulin treatment, recent high-dose steroids or immunosuppressants, diabetes, or IgA deficiency.
04
Endpoints
Primary
Adjusted INCAT disability score
Secondary
Vital Signs
Grip Strength
Nerve Conduction Studies
Motor Impairment Assessment utilizing the Expanded MRC Sum Score
Number of adverse events
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