Study of the effect of subcutaneous administration of immunoglobulin in patients with newly diagnosed chronic inflammatory demyelinating polyradiculoneuropathy

Randomized, single-blind crossover study of subcutaneous immunoglobulin in newly diagnosed patients with chronic inflammatory demyelinating polyradiculoneuropathy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001428-20-DK

Enrollment

Unknown

Registered

2013-06-06

Start date

2013-06-06

Completion date

Unknown

Last updated

2016-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 16.0 Level: PT Classification code 10064135 Term: Polyneuropathy chronic System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: Hizentra Product Name: Hizentra Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: Human normal immunoglobulin CAS Number: 0 Other descriptive name: HUMAN NOR

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients diagnosed with typical or pure motor CIDP fulfilling the European Federation of Neurological Societies / Peripheral Nerve Society (EFNS/PNS) clinical and electrophysiological criteria for definite or probable CIDP. Age > 18 and =65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: Age 80 years at inclusion Pregnancy Increased coagulation time (INR > 1.5, thrombocyte count < 100 million/ml) Malignancies Other causes of neuropathy (Diabetes mellitus, MGUS) Severe medical diseases Other immunomodulating treatment in the last 6 weeks Hepatitis B and C or HIV Lactation Allergy to immunoglobulin Known Immunoglobulin A deficiency

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess efficacy of immunoglobulin administered subcutaneously compared to intravenous administration in de-novo patients with CIDP;Secondary Objective: To assess the differencies and changes in muscle strength between subcutanoeus and intravenous administration;Primary end point(s): Changes in dynamometric muscle strength, measured by Biodex System 3 dynamometer, of four preselected and affected muscle groups from baseline until last evaluation;Timepoint(s) of evaluation of this end point: All patients are evaluated 7 times during the study period: 0, 2, 5, 10, 12, 15 and 20 weeks after inclusion	—

Measure

Time frame

Main Objective: To assess efficacy of immunoglobulin administered subcutaneously compared to intravenous administration in de-novo patients with CIDP;Secondary Objective: To assess the differencies and changes in muscle strength between subcutanoeus and intravenous administration;Primary end point(s): Changes in dynamometric muscle strength, measured by Biodex System 3 dynamometer, of four preselected and affected muscle groups from baseline until last evaluation;Timepoint(s) of evaluation of this end point: All patients are evaluated 7 times during the study period: 0, 2, 5, 10, 12, 15 and 20 weeks after inclusion

—

Secondary

Measure	Time frame
Secondary end point(s): Changes in other scores defining muscle strength and disability - Clinical muscle strength (MRC) - Grip strength - 9-hole-peg test - 40-meter-walking test - INCAT Overall Disability Sum Score (ODSS) - Plasma IgG levels;Timepoint(s) of evaluation of this end point: All patients are evaluated 7 times during the study period: 0, 2, 5, 10, 12, 15 and 20 weeks after inclusion	—

Countries

Denmark

Contacts

Public ContactLars Markvardsen

Aarhus University Hospital, Department of Neurology

larsmark@rm.dk004578463337

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026