Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2025-12-24 @ 2:38 PM
NCT ID:
NCT01017159
Eligibility Criteria:
Inclusion Criteria:
* All patients with typical or pure motor CIDP, who meet the clinical or electrophysiological criteria of the EFNS/PNS for certain or probable CIDP and who are in regular treatment with IVIg on one of the neurological departments in Denmark, are eligible for the study
Exclusion Criteria:
* Pregnancy
* Known cancer disease
* Severe medical diseases
* Other immuno modulating treatment than low-dose steroid (prednisolone \< 25 mg/day) within the last 6 weeks before inclusion
* Hepatitis B or C or HIV
* Breast-feeding
* Non-responding to treatment with intravenous immunoglobulin
* Known hypersensitivity to intravenous immunoglobulins or Kiovig
Adverse events:
* Previous moderate headache or minor rash for a few days during or after infusion is not an exclusion criteria
* In case of severe adverse effects to treatment patients are excluded. Moderate or mild side-effects can be treated with analgetics or steroids for 1-2 weeks during the initial study phase
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01017159
Study Brief:
Protocol Section:
NCT01017159