Safety and Efficacy Study of Three Different Dosages of NewGam in Patients With CIDP (POINT)
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|ClinicalTrials.gov Identifier: NCT01225276|
Recruitment Status : Terminated (Study Terminated.priority changes in product development.)
First Posted : October 20, 2010
Last Update Posted : February 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Inflammatory Demyelinating Polyradiculoneuropathy||Drug: NewGam 10% Drug: Placebo||Phase 2 Phase 3|
This is a Phase 2/3 study that will take place in 2 stages. The primary objective of Stage 1 (Phase 2 dose-finding part)is to determine and select one dosage from three NewGam maintenance dosage arms in comparison with a placebo arm, based on the percentage of responders (response defined as a decrease, meaning improvement, in the adjusted INCAT disability score by at least 1 point). The selected NewGam dosage and placebo will be employed and compared in Stage 2.
The primary objective of Stage 2 (Phase 3 confirmatory part) is to demonstrate superiority of the maintenance dosage regimen selected at study Stage 1 over placebo in patients with CIDP as assessed by the percentage of responders.
The secondary objective is to evaluate the safety (measured by number of adverse events)and efficacy of NewGam administration in patients with CIDP compared to baseline.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Double-blind, Placebo-controlled, Randomised, Multicentre, Adaptive, Two-stage Phase 2/3 Study Evaluating Safety and Efficacy of Three Dosages of NewGam in CIDP Patients|
|Study Start Date :||October 2011|
|Primary Completion Date :||October 2012|
|Study Completion Date :||October 2012|
Experimental: Dosage Arm 1
NewGam 10% 0.4 g/kg
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.
Experimental: Dosage Arm 2
NewGam 10% 1.0 g/kg
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.
Experimental: Dosage Arm 3
NewGam 10% 2.0 g/kg
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.
Placebo Comparator: Dosage Arm 4
Placebo 0.9% Saline
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.
Other Name: 0.9% saline solution
- Adjusted INCAT disability score [ Time Frame: Every 3 weeks for 48 weeks (stage 1) or 36 weeks (stage 2) ]
- Vital Signs [ Time Frame: During each infusion - Every 3 weeks for 48 weeks (stage 1) or 36 weeks (stage 2) ]
- Grip Strength [ Time Frame: Visit 9 & 13 ]
- Nerve Conduction Studies [ Time Frame: Visti 9 & 13 ]
- Motor Impairment Assessment utlizing the Expanded MRC Sum Score [ Time Frame: Every 3 weeks for 48 weeks (stage 1) or 36 weeks (stage 2) ]Expanded 'Medical Research Council sum score' will be measured as improvement in MRC units .
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01225276
|Study Director:||Wolfgang Frenzel, MD||Octapharma|