Clinical Trial: Safety and Efficacy Study of Three Different Dosages of NewGam in Patients With CIDP

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief Summary: NewGam (current working title for a new IGIV formulation) is a newly developed human normal immunoglobulin solution ready for intravenous administration (IGIV). This study will evaluate the safety and efficacy of three different dosages of NewGam 10% in patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy.

Detailed Summary:

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.


Sponsor: Octapharma

Current Primary Outcome: Adjusted INCAT disability score [ Time Frame: Every 3 weeks for 48 weeks (stage 1) or 36 weeks (stage 2) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 .


Original Secondary Outcome:

  • To evaluate the safety of NewGam [ 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 ]
  • Expanded MRC Sum Score [ Time Frame: Every 3 weeks for 48 weeks (stage 1) or 36 weeks (stage 2) ]


Information By: Octapharma

Dates:
Date Received: October 6, 2010
Date Started: October 2011
Date Completion:
Last Updated: February 20, 2017
Last Verified: February 2017