Randomiseret, dobbelt blindet placebokontrolleret undersøgelse af subkutan immunglobulinbehandling af kronisk inflammatorisk demyeliniserende polyradikuloneuropati (English: A randomized, double-blinded, placebo controlled trial of subcutaneous infusion of immunoglobulin in chronic inflammatory demyelinating polyradiculoneuropathy) - Subcutaneous Immunoglobulin in CIDP

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-013930-25-DK

Enrollment

Registered

2009-09-25

Start date

2009-11-24

Completion date

Unknown

Last updated

2021-08-02

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

Conditions

Chronic inflammatory demyelinating polyradiculoneuropathy MedDRA version: 12.0 Level: LLT Classification code 10057645 Term: Chronic inflammatory demyelinating polyradiculoneuropathy

Interventions

Trade Name: Subcuvia Pharmaceutical Form: Concentrate for solution for injection CAS Number: 0 Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Concentration unit: mg/ml milligram(s)/millilitre Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients having typical or pure motor CIDP fulfilling European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) clinical and electrophysiological criteria for definite or probable CIDP and in regular treatment with IVIG at neurological departments in Denmark Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Age below 18 and above 80 years at time of inclusion. Pregnancy. Increased coagulation time (INR > 1.5, thrombocyte count < 100 milion/ml)) Malignancies. Other causes of neuropathy (diabetes melitus, MGUS) Severe medical diseases Other immunomodulating treatment than IVIG within the last 6 weeks. Hepatitis B or C or HIV Lactation. Non-responsiveness to IVIG treatment. Allergy to immunglobulin

Design outcomes

Primary

Measure	Time frame
Main Objective: to assess efficacy, feasibility and safety of frequent small doses of immunoglobulin administered subcutaneously compared to subcutaneous administration of placebo in CIDP patients.;Secondary Objective: to assess efficacy of immunoglobulin administered subcutaneously compared to intravenous immunoglobulin (IVIG) ;Primary end point(s): The change in dynamometric muscle strength, measured by the Biodex System 3® dynamometer, of four pre-selected muscle groups from baseline until last evaluation in the active treatment group versus placebo.	—

Measure

Time frame

Main Objective: to assess efficacy, feasibility and safety of frequent small doses of immunoglobulin administered subcutaneously compared to subcutaneous administration of placebo in CIDP patients.;Secondary Objective: to assess efficacy of immunoglobulin administered subcutaneously compared to intravenous immunoglobulin (IVIG) ;Primary end point(s): The change in dynamometric muscle strength, measured by the Biodex System 3® dynamometer, of four pre-selected muscle groups from baseline until last evaluation in the active treatment group versus placebo.

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Countries

Denmark

Outcome results

None listed

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