Status:
TERMINATED
Safety and Efficacy Study of Three Different Dosages of NewGam in Patients With CIDP
Lead Sponsor:
Octapharma
Conditions:
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Patients diagnosed as having CIDP based on fulfilment of clinical criteria of the INCAT Group and the definite electrophysiological criteria for CIDP ; patients with MADSAM or pure motor CIDP will be included provided they fulfil these criteria
- Worsening of disability and objective increase in weakness or sensory deficit during the 6 months prior to screening
- \>=18 years of age
Exclusion
- Unifocal forms of CIDP
- Pure sensory CIDP
- MMN with conduction block
- Treatment of CIDP with immunoglobulins (intravenous or subcutaneous) at any time prior to study entry
- Steroids of any type equivalent to prednisolone or prednisone \> 10 mg/day or equivalent plasma exchange (PE) during the last 3 months prior to baseline visit
- Treatment with cyclosporin, methotrexate, mitoxantrone, mycophenolate mofetil, interferon or other immunosuppressive or immunomodulatory drugs during the three months prior to baseline visit
- Clinical evidence of peripheral neuropathy from another
- Known diabetes mellitus
- Other serious medical condition complicating assessment or treatment
- Thromboembolic events: patients with a history of deep vein thrombosis (DVT) within the last year prior to baseline visit or pulmonary embolism ever
- Known IgA deficiency with antibodies to IgA
- History of hypersensitivity, anaphylaxis or severe systemic response to immunoglobulin, blood or plasma derived products, or any component of NewGam
- Known blood hyperviscosity
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01225276
Start Date
October 1 2011
End Date
October 1 2012
Last Update
February 23 2017
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