E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Myasthenia gravis |
Miastenia gravis |
|
E.1.1.1 | Medical condition in easily understood language |
Myasthenia gravis |
Miastenia gravis |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10028417 |
E.1.2 | Term | Myasthenia gravis |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
|
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
preoperatively administered intravenous immunoglobulin (IVIg) is an effective preparatory measure for reducing the incidence of myasthenic crises |
evaluar la eficacia de las IgIV (Privigen®), administradas preoperatoriamente, en la prevención de crisis miasténica en sujetos con MG a quienes se les va a practicar una timectomía u otro procedimiento quirúrgico que requiera anestesia general |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the length of the hospital stay and functional status measured by the MGFA |
Valorar la eficacia de IgIV (Privigen®), administradas preoperatoriamente, en la reducción de la estancia hospitalaria y en los cambios de la puntuación QMG medidos con la escala MGFA. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age >18 years, diagnostic of myasthenia gravis and surgical procedures requiring general anesthesia, including thymectomy. |
Edad >18 años, diagnosticados de una forma generalizada de MG (clases II, III y IV de la MGFA), que vayan a ser timectomizados o que requieran una intervención quirúrgica programada con anestesia general |
|
E.4 | Principal exclusion criteria |
Hipersensibilidad al principio activo o a alguno de los excipientes, o a las inmunoglobulinas homólogas. Niveles de IgA inferiores al 5% de los valores mínimos normales. Enfermedades graves concomitantes. Historia de episodios trombóticos. Historia de hemolisis, meningitis aséptica o cefalea recurrente grave después de infusión intravenosas de inmunoglobulinas Reacciones cutáneas generalizadas graves. Embarazo, Lactancia. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
incidence of myasthenic crises |
incidencia de crisis miasténicas |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
After surgery and every day while the patient remains in hospital |
Después de la cirugía hasta el alta |
|
E.5.2 | Secondary end point(s) |
length of the hospital stay and functional status measured by the MGFA |
duración de la hospitalización y escala de estado funcional con la escala MGFA |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
After surgery and every day while the patient remains in hospital |
Después de la cirugía hasta el alta |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
last visit of the last subject undergoing the trial |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |