EUCTR2006-004374-27-DE
Active, not recruiting
Not Applicable
Prospective, randomized, doubleblind, placebo-controlled trial on changes in acetylcholine receptor antibody titres in autoimmune myasthenia gravis after influenza vaccination (ProPATIent) - ProPATIent
Philipps-University0 sitesSeptember 7, 2006
DrugsMutagrip
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Generalized Myasthenia gravis with positive antibodies against Acetylcholine-receptors (ICD10GM2006 G70.0)
- Sponsor
- Philipps-University
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •written informed consent
- •diagnosis of a generalized Myasthenia gravis (ICD10GM2006: G70\.0\)
- •positive Acetylcholine receptor antibodies
- •stable clinical course for at least 4 weeks before inclusion in the study
- •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
- •contraindication for Mutagrip according to the Fachinformation
- •any vaccination in the last 9 months prior to study entry
- •serious or acute heart disease (e. g. uncontrolled cardiac dysrhythmias, angina pectoris, cardiomyopathy, congestive heart failure)
- •known allergy to chicken proteins, neomycine, formaldehyde, Octoxinol 9\)
- •current infection or current pyrexia
- •history of cancer
- •severe adverse event in earlier vaccination
- •current participation in another clinical trail
Outcomes
Primary Outcomes
Not specified
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