EUCTR2014-005496-87-GR
Active, not recruiting
Phase 1
A Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase (HYQVIA/HyQvia) and Immune Globulin Infusion (Human), 10% (GAMMAGARD LIQUID/KIOVIG) for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) - Phase III Efficacy, Safety, and Tolerability Study of HyQvia and KIOVIG in CIDP
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Baxalta Innovations GmbH
- Enrollment
- 132
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Males or females of age \=18 years old at the time of screening.
- •2\. Subject has a documented diagnosis of definite or probable CIDP (focal atypical CIDP and pure sensory atypical CIDP will be excluded).
- •3\. Subject has responded to IgG treatment in the past, (partial or complete resolution of neurological symptoms and deficits), and must currently be on stable doses of IGIV treatment within the dose range equivalent to a cumulative monthly dose of 0\.4 to 2\.4 g/kg BW (inclusive) administered intravenously for at least 3 months prior to screening. The dosing interval of IGIV treatment must be between 2 to 6 weeks (inclusive).
- •4\. INCAT disability score between 0 to 7 (inclusive). Subjects with INCAT scores of 0, 1 (whether from upper or lower extremities), or 2 (if at least 1 point is from an upper extremity) at screening and/or baseline will be required to have a history of significant disability as defined by an INCAT disability score of 2 (must be exclusively from the lower extremities) or greater within 24 months prior to screening.
- •5\. If female of childbearing potential, the subject must have a negative pregnancy test at screening and agree to employ a highly effective contraceptive measure throughout the course of the study and for at least 30 days after the last administration of investigational product.
- •6\. Subject is willing and able to sign an Informed Consent Form (ICF).
- •7\. Subject is willing and able to comply with the requirements of the protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •1\.Subjects with focal atypical CIDP or pure sensory atypical CIDP.
- •2\. Any neuropathy of other causes, including:
- •a. Hereditary demyelinating neuropathies, such as hereditary sensory
- •and motor neuropathy (Charcot\-Marie\-Tooth \[CMT] disease), and
- •hereditary sensory and autonomic neuropathies.
- •b. Neuropathies secondary to infections, disorders, or systemic diseases
- •such as Borrelia burgdorferi infection (Lyme disease), diphtheria,
- •systemic lupus erythematosus, POEMS (polyneuropathy, organomegaly,
- •endocrinopathy, M\-protein, and skin changes) syndrome, osteosclerotic
- •myeloma, diabetic and non\-diabetic lumbosacral radiculoplexus
Outcomes
Primary Outcomes
Not specified
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