A 5-Year, Extension, Follow-up, Blinded-Outcomes Trial of Subjects Having Received Stannsoporfin or Placebo in Clinical Trial 64,185-202Un estudio ciego de seguimiento y ampliación de 5 años de duración de pacientes que recibieron estansoporfina o placebo en el ensayo clínico 64.185-202
- Conditions
- eonatal hyperbilirubinemiaHiperbilirrubinemia NeonatalMedDRA version: 12.1Level: LLTClassification code 10020580Term: Hyperbilirubinaemia neonatal
- Registration Number
- EUCTR2009-018267-27-ES
- Lead Sponsor
- InfaCare Pharmaceutical Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
- Sujetos que hayan recibido el PEI en el ensayo clínico 64.185-202
- Consentimiento informado escrito
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
No aplica
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate any potential long-term effects of stannsoporfin (Stanate) on the health, growth, and development of subjects who received a single dose of stannsoporfin compared with subjects in the control (placebo) group in clinical trial 64,185-202.;Secondary Objective: None;Primary end point(s): Las evaluaciones de la seguridad se basarán en las siguientes variables:<br>· Acontecimientos adversos notificados (EA)<br>· Historial de enfermedad, incluida hospitalización<br>· Mediciones de las constantes vitales<br>· Exámenes físicos<br>· Exámenes auditivos<br>· Exámenes oculares<br>· Exámenes neurológicos<br>· Análisis clínicos de laboratorio
- Secondary Outcome Measures
Name Time Method