Clinical Trial: HyQvia in Multifocal Motor Neuropathy

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Subcutaneous Immunoglobulin With rHuPH20 in Multifocal Motor Neuropathy

Brief Summary: Subcutaneous immunoglobulin (SCIG) and recombinant human hyaluronidase (rHuPH20) will be tested in patient witch MMN and currently under maintenance treatment with IVIG for safety, tolerability and efficacy.

Detailed Summary:

Multifocal motor neuropathy (MMN) is a chronic immune mediated neuropathy, which affects patients at a relatively young age and necessitates treatment with immunoglobulins (Ig) to improve and maintain muscle strength. Subcutaneous immunoglobulin (SCIG) therapy for MMN is equally efficacious to intravenous immunoglobulin (IVIG), may be self-administered and may induce fewer systemic adverse reactions. However, limited subcutaneous infusion volumes and reduced bioavailability, necessitate multiple infusion sites, more frequent treatment, and dose adjustment to achieve pharmacokinetic equivalence. This is an issue in particular in MMN where relatively high and frequent doses are necessary to maintain long-term improvement of muscle strength. Recombinant human hyaluronidase (rHuPH20) increases subcutaneous tissue permeability and facilitates dispersion and absorption, enabling subcutaneous administration of higher (monthly) doses of Ig. If treatment with HyQvia is at least equally effective and safe as compared with conventional Ig treatment, HyQvia could become the preferred treatment option for patients with MMN as it may have attractive benefits for patients by its mode of administration.

Objective:

The primary objective is to study the safety and tolerability of HyQvia in patients with

MMN as compared with conventional intravenous, by documenting:

  • Side effects by using a diary and a 10 cm visual analogue scale (VAS) scales to measure headache and nausea.
  • Biochemical tests (Hemoglobin, haptoglobin, reticulocyte counts, lactate dehydrogenase, bilirubin, DAT) for haemolytic anemia 3-7 days after the last IVIG/SCIG infusion, during the enrolment period and 3-7 da
    Sponsor: UMC Utrecht

    Current Primary Outcome: Safety measured by anamnesis [ Time Frame: 1 year ]

    presence of headache, gastrointestinal complaints, fatigue, flue-like symptoms


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Quality of life (QoL) measured by a VAS questionnaire [ Time Frame: 1 year ]
      VAS questionnaire every visit at the outpatient clinic.
    • Stability of muscle strength [ Time Frame: 1 year ]
      Every visit at the outpatient clinic a Guy's neurologic disability scale (GNDS) and MRC sum score are obtained
    • Safety measured by questionnaire [ Time Frame: 1 year ]
      QoL questionnaire measured in a VAS number
    • Safety measured by blood test [ Time Frame: 1 year ]
      Liver tests and blood counts


    Original Secondary Outcome: Same as current

    Information By: UMC Utrecht

    Dates:
    Date Received: January 25, 2016
    Date Started: September 2016
    Date Completion: January 2018
    Last Updated: August 25, 2016
    Last Verified: August 2016