Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
60 participants
INTERVENTIONAL
2020-06-04
2030-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Patients treated with immunoglobulin intravenously (IVIG)
Immunoglobulin (PRIVIGEN) intravenously 2 g/kg/4week for 26 weeks. After this 60 weeks of reduction every 12 weeks (90%, 75%, 50%, 25% and 0%).
Immunoglobulin
Randomization 1:1 to the same total dose of either SCIG or IVIG for 26 weeks of stable dose + 60 weeks of redcution.
Patients treated with immunoglobulin subcutaneously (SCIG)
Immunoglobulin (HIZENTRA) subcutaneously 0.54 g/kg/week for 26 weeks. After this 60 weeks of reduction every 12 weeks (90%, 75%, 50%, 25% and 0%).
Immunoglobulin
Randomization 1:1 to the same total dose of either SCIG or IVIG for 26 weeks of stable dose + 60 weeks of redcution.
Interventions
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Immunoglobulin
Randomization 1:1 to the same total dose of either SCIG or IVIG for 26 weeks of stable dose + 60 weeks of redcution.
Eligibility Criteria
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Inclusion Criteria
* No previous treatment with IVIG or SCIG.
* Age ≥ 18.
* ODSS ≥ 2 - either (arm/leg): 1/1, 2/0 or 0/2 at the time of inclusion.
Clinical criteria for typical CIDP
* Chronically progressive, stepwise, or recurrent symmetric proximal and distal weakness and sensory dysfunction of all extremities, developing over at least 2 months; cranial nerves may be affected.
* Absent or reduced tendon reflexes in all extremities.
Criteria for pure motor CIDP • Pure motor affection; otherwise as for typical CIDP.
Electrophysiological criteria for CIDP
1. Motor distal latency prolongation ≥50% above ULN in two nerves (excluding median neuropathy at the wrist from carpal tunnel syndrome), or
2. Reduction of motor conduction velocity ≥30% below LLN in two nerves, or
3. Prolongation of F-wave latency ≥30% above ULN in two nerves (≥50% if amplitude of distal negative peak CMAP ≤80% of LLN values), or
4. Absence of F-waves in two nerves of these nerves have distal negative peak CMAP amplitudes ≥20% of LLN + ≥1 other demyelinating parameter in ≥1 other nerve, or
5. Partial motor conduction block: ≥50% amplitude reduction of the proximal negative peak CMAP relative to distal, if distal negative peak CMAP \>20% of LLN, in two nerves, or in one nerve + ≥1 other demyelinating parameter in ≥1 other nerve, or
6. Abnormal dispersion (≥30% duration increase between the proximal and distal negative peak CMAP) in ≥2 nerves, or
7. Distal CMAP duration (interval between onset of the first negative peak an return to baseline of the last negative peak) increase in ≥1 nerve (median ≥6.6 ms, ulnar ≥6.7 ms, peroneal ≥7.6 ms, tibial ≥8.8 ms) + ≥1 other demyelinating parameter in ≥1 other nerve
Electrophysiological criteria for probable CIDP
(a) ≥30% amplitude reduction of the proximal negative peak CMAP relative to distal, excluding the posterior tibial nerve, if distal negative peak CMAP ≥20% of LLN, in two nerves, or in one nerve + ≥1 other demyelinating parameter in ≥1 other nerve
Exclusion Criteria
* Increased risk of thromboembolism
* Pregnancy (Plasma HCG is tested at inclusion in all fertile women)
* Breast feeding
* Malignancy
* Severe medical disease
* Other immune modulating treatment than low dose steroid (prednisolon \< 25 mg daily) within the last 6 months prior to inclusion
* Hepatitis B or C or HIV infection (screening at inclusion)
* Known IgA deficiency
* Known allergy to consents in PRIVIGEN or HIZENTRA
* Body weight \> 120 kg
After treatment initiation:
* Pregnancy
* Serious medical disease that affects treatment or examinations
* Non-compliance to treatment
* Initiation of other immune modulating therapy
* Unacceptable side effects
* Withdrawal of consent to participate (drop-out)
18 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Aarhus University Hospital
OTHER
Odense University Hospital
OTHER
Aalborg University Hospital
OTHER
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Henning Andersen, MD,DMSc,PhD
Role: PRINCIPAL_INVESTIGATOR
Aarhus University, Aarhus University Hospital
Locations
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Department of Neurology, Aalborg University Hospital
Aalborg, , Denmark
Department of Neurology, Aarhus University Hospital
Aarhus C, , Denmark
Department of Neurology, Rigshospitalet, Copenhagen University Hospital
Copenhagen, , Denmark
Department of Neurology, Odense University Hospital
Odense, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2018-003592-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AUH-2018-100
Identifier Type: -
Identifier Source: org_study_id
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