A Study of Purified Human Antibodies Administered Subcutaneously to Patients With Multifocal Motor Neuropathy (MMN)

CSL Behring

Status and phase: Completed; Phase 2

Conditions: Multifocal Motor Neuropathy (MMN)

Treatments: Biological: Vivaglobin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00701662

ZLB06_006CR (Other Identifier)

1464

2007-000710-37 (EudraCT Number)

Details and patient eligibility

About

The objective of this study is to assess efficacy, safety, and convenience of purified human antibodies administered under the skin in the treatment of MMN patients.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with documented clinical diagnosis and electrophysiological evidence of MMN
• Patients who have previously responded to intravenous immunoglobulin (IVIG) and have been on stable treatment with IVIG for at least 12 weeks prior to screening
• Patients treated with the equivalent of ≥0.4g/kg body weight (bw) IVIG per month
• Provision of informed consent by patient

Exclusion criteria

• Aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) concentration >2.5 times the upper normal limit (UNL)
• Creatinine concentration >1.5 times the UNL
• Known allergic reactions to blood products
• Any skin disease interfering with the assessment of injection site reactions
• Any other medical condition, which in the opinion of the investigator, might interfere with successful completion of the protocol
• Any condition likely to interfere with the evaluation of the study drug or satisfactory conduct of the trial
• Participation in a study with an investigational drug within three months prior to enrolment
• Patients treated with the equivalent of >2.0g/kg bw IVIG per month

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Vivaglobin

Experimental group

Description:

Vivaglobin® is a 16% (160 mg/mL) liquid formulation of human normal immunoglobulin for subcutaneous infusion. Subjects will receive weekly infusions of Vivaglobin® at a weekly dosage calculated based on previous intravenous immunoglobulin treatment (between 0.1 to 0.5 g/kg body weight per week).

Treatment:

Biological: Vivaglobin