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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001544-21-ES

Enrollment

Registered

2012-08-23

Start date

2012-11-07

Completion date

Unknown

Last updated

2012-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myasthenia gravis MedDRA version: 15.0 Level: PT Classification code 10028417 Term: Myasthenia gravis System Organ Class: 10029205 - Nervous system disorders

Interventions

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: e

Eligibility

Sex/Gender

All

Inclusion 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

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Main Objective: preoperatively administered intravenous immunoglobulin (IVIg) is an effective preparatory measure for reducing the incidence of myasthenic crises;Secondary Objective: To evaluate the length of the hospital stay and functional status measured by the MGFA;Primary end point(s): incidence of myasthenic crises;Timepoint(s) of evaluation of this end point: After surgery and every day while the patient remains in hospital	—

Measure

Time frame

Main Objective: preoperatively administered intravenous immunoglobulin (IVIg) is an effective preparatory measure for reducing the incidence of myasthenic crises;Secondary Objective: To evaluate the length of the hospital stay and functional status measured by the MGFA;Primary end point(s): incidence of myasthenic crises;Timepoint(s) of evaluation of this end point: After surgery and every day while the patient remains in hospital

—

Secondary

Measure	Time frame
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	—

Countries

Spain

Contacts

Public ContactStudy coordinator

Dr Jose Gámez Carbonell

jgamez@vhebron.net349327460006596

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026