E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Lower limb critical ischemia |
Isquemia crítica de miembros inferiores |
|
E.1.1.1 | Medical condition in easily understood language |
Circulation deficit at risk of amputation |
Falta de circulación con riesgo de amputación |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023034 |
E.1.2 | Term | Ischemia peripheral |
E.1.2 | System Organ Class | 100000004866 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10058069 |
E.1.2 | Term | Critical limb ischemia |
E.1.2 | System Organ Class | 100000004866 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066920 |
E.1.2 | Term | Leg ischemia |
E.1.2 | System Organ Class | 100000004866 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the angiogenic efficacy and the safety of subcutaneus growth hormone (sGH) on patients with lower limb critical ischemia |
Evaluar la eficacia angiogénica y la seguridad de la hormona del crecimiento subcutánea (sGH) en pacientes con isquemia crítica de miembros inferiores |
|
E.2.2 | Secondary objectives of the trial |
To determine the onset time of angiogenic action of sGH after injection To compare the severity of peripheral artery disease among treatment groups (sGH and placebo) according to protocol tests at time 0, 30 days and 60 days (end of treatment) To evaluate long term effects of sGH after end of treatment (1 year) To evaluate the safety of sGH treatment through adverse events description. |
Determinar el momento de inicio de la acción angiogénica de la sGH una vez es administrada Comparar la gravedad de enfermedad arterial periférica entre los grupos de tratamiento (sGH y placebo) con las pruebas descritas en el protocolo en el momento basal, 30 días y final de tratamiento (60 días) Evaluar el efecto de la sGH a largo plazo tras la interrupción del tratamiento (1 año) Evaluar la seguridad del tratamiento con GH para esta indicación mediante descripción de los eventos adversos. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with lower limbs critical ischemia by mean: trophic lesions and/or rest pain and/or night pain of ischemic origin and ankle-brachial index (ABI) equal or lower than 0.4 Failed previous attempts of revascularization through main methods: surgical and/or endovascular therapies. High risk of loss limb |
Pacientes con Isquemia Crítica de la Extremidad Inferior diagnosticada por métodos clínicos (lesiones tróficas y/o dolor de reposo o nocturno de naturaleza isquémica) y hemodinámicos (Índice Tobillo-Brazo o ITB igual o menor de 0.4) Fallo de intento previo de revascularización por los métodos principales: terapias quirúrgica y/o endovascular Alto riesgo de pérdida de la extremidad. |
|
E.4 | Principal exclusion criteria |
Fertile women Aged under 18 Legally incapable Onchologic patients Sepsis |
Mujeres en edad fértil Menores de edad Incapacitados legalmente Pacientes oncológicos Sepsis |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Photopletismography (wave in milimeters) |
Fotopletismografía (onda en milímetros) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
0 days 30 days 60 days 1 year |
0 días 30 días 60 días 1 año |
|
E.5.2 | Secondary end point(s) |
Doppler study: systolic speed, diastolic speed, pulsatility index, ABI, morphological analysis of the curve Angio-CT |
Estudio Doppler: velocidad Sistólica; velocidad diastólica, índice de pulsatilidad, índice tobillo-brazo; análisis morfológico de la curva Angio-TAC |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
0 days 30 days (except angioCT) 60 days 1 year (except angioCT) |
0 días 30 días (salvo angioTAC) 60 días 1 año (salvo angioTAC) |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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
|
The study ends after the last clinical examination (1 year after end of treatment) of the last patient |
El estudio finaliza tras la revisión al año de finalización del tratamiento del último paciente incluido. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
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 | 1 |
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 |