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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 3 December 2012
Main ID:  EUCTR2012-001544-21-ES
Date of registration: 23/08/2012
Prospective Registration: Yes
Primary sponsor: Vall d'Hebron Institut de Recerca (VHIR)
Public title: Intravenous immunoglobulin for preparing myasthenia gravis patients for thymectomy and other surgical procedures preventing myasthenic crisis.
Scientific title: Intravenous immunoglobulin for preparing myasthenia gravis patients for thymectomy and other surgical procedures preventing myasthenic crisis.
Date of first enrolment: 07/11/2012
Target sample size: 84
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-001544-21
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2  
Phase: 
Countries of recruitment
Spain
Contacts
Name: Study coordinator   
Address:  Paseo Vall d'Hebron 119-129 08035 Barcelona Spain
Telephone: 349327460006596
Email: jgamez@vhebron.net
Affiliation:  Dr Jose Gámez Carbonell
Name: Study coordinator   
Address:  Paseo Vall d'Hebron 119-129 08035 Barcelona Spain
Telephone: 349327460006596
Email: jgamez@vhebron.net
Affiliation:  Dr Jose Gámez Carbonell
Key inclusion & exclusion criteria
Inclusion criteria:
Age >18 years, diagnostic of myasthenia gravis and surgical procedures requiring general anesthesia, including thymectomy.
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 42
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 42

Exclusion criteria:


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Myasthenia gravis
MedDRA version: 15.0 Level: PT Classification code 10028417 Term: Myasthenia gravis System Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intervention(s)

Trade Name: PRIVIGEN
Pharmaceutical Form: Solution for infusion
CAS Number: 308067-58-5
Other descriptive name: IMMUNOGLOBULIN G
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)
Main Objective: preoperatively administered intravenous immunoglobulin (IVIg) is an effective preparatory measure for reducing the incidence of myasthenic crises
Primary end point(s): incidence of myasthenic crises
Secondary Objective: To evaluate the length of the hospital stay and functional status measured by the MGFA
Timepoint(s) of evaluation of this end point: After surgery and every day while the patient remains in hospital
Secondary Outcome(s)
Secondary end point(s): length of the hospital stay and functional status measured by the MGFA
Timepoint(s) of evaluation of this end point: After surgery and every day while the patient remains in hospital
Secondary ID(s)
MG2012PREP
Source(s) of Monetary Support
VHIR
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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