Intravenous immunoglobulin for preparing myasthenia gravis patients for thymectomy and other surgical procedures preventing myasthenic crisis.

• 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

Countries of recruitment

Spain

Contacts

• Name: Study coordinator
• Affiliation: Dr Jose Gámez Carbonell

• Name: Study coordinator
• 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

Timepoint(s) of evaluation of this end point: After surgery and every day while the patient remains in hospital

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

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: After surgery and every day while the patient remains in hospital

Secondary end point(s): length of the hospital stay and functional status measured by the MGFA

Secondary ID(s)

MG2012PREP

Source(s) of Monetary Support

VHIR