NCT01225276 - Safety and Efficacy Study of Three Different Dosages of NewGam in Patients With CIDP | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

October 31, 2012

Study Completion Date

October 31, 2012

Conditions

Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Interventions

DRUG

NewGam 10%

Loading dose at baseline (Week 0) will be 2.0 g/kg NewGam . The maintenance doses to be infused 7 times will be 2.0 g/kg every 21 (+/-4) days.

DRUG

Placebo

Loading dose at baseline (Week 0) in Placebo arm will be corresponding volume of an authorised 0.9% saline solution . The maintenance doses of the 0.9% saline solution to be infused 7 times will be given every 21 (+/-4) days.

DRUG

NewGam 10%

Loading dose at baseline (Week 0) will be 2.0 g/kg NewGam in all three NewGam treatment arms. The maintenance doses to be infused 7 times will be 1.0 g/kg every 21 (+/-4) days.

DRUG

NewGam 10%

Loading dose at baseline (Week 0) will be 2.0 g/kg NewGam in all three NewGam treatment arms. The maintenance doses to be infused 7 times will be 0.4 g/kg every 21 (+/-4) days.