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Immunoglobulin Dosage and Administration Form in CIDP and MMN

NCT02111590 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 36

Last updated 2015-09-22

No results posted yet for this study

Summary

The aim of this study is to evaluate development of hemolysis and the variation in isokinetic muscle strength in two groups of patients with chronic inflammatory demyelinating polyneuropathy (CIDP) or multifocal motor neuropathy (MMN)

1. Patients shifted from 3- or 6-weekly treatment with intravenous immunoglobulin (IVIG) to weekly treatment with subcutanoeus immunoglobulin (SCIG)
2. Patients shifted from SCIG treatment with Subcuvia® or Hizentra® to Gammanorm®.

Hypotheses

* During treatment with IVIG blood hemoglobin will fluctuate with a decline due to infusion, whereas it will remain stable during SCIG treatment without fluctuation
* Isokinetic muscle strength in affected muscle groups is more stable during treatment with SCIG than with IVIG
* Blood hemoglobin and changes in muscle strength is comparable during Subcuvia® or Hizentra® and Gammanorm® treatment

Conditions

Interventions

DRUG

Immunoglobulins

SCIG dosage is individualized for each patient according to previous IVIG dosage

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • Octapharma Pharmazeutika Produktionsges.m.b.H.

    collaborator UNKNOWN

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Johannes Jakobsen, DMSc · Neuroscience Center, Rigshospitalet

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02111590 on ClinicalTrials.gov