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A 5-Year, Extension, Follow-up, Blinded-Outcomes Trial of Subjects Having Received Stannsoporfin or Placebo in Clinical Trial 64,185-202 "Un 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"

A 5-Year, Extension, Follow-up, Blinded-Outcomes Trial of Subjects Having Received Stannsoporfin or Placebo in Clinical Trial 64,185-202 "Un 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"

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-018267-27-ES
Enrollment
72
Registered
2010-01-22
Start date
2010-06-08
Completion date
Unknown
Last updated
2015-07-10

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

Conditions

Neonatal hyperbilirubinemia Hiperbilirrubinemia Neonatal MedDRA version: 12.1 Level: LLT Classification code 10020580 Term: Hyperbilirubinaemia neonatal

Interventions

Product Name: Stannsoporfin Pharmaceutical Form: Injection* INN or Proposed INN: STANNSOPORFIN CAS Number: 106344201 Other descriptive name: Stanate Concentration unit: mg/ml milligram(s)/millilitre C

Sponsors

InfaCare Pharmaceutical Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: No aplica

Design outcomes

Primary

MeasureTime frame
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: · Acontecimientos adversos notificados (EA) · Historial de enfermedad, incluida hospitalización · Mediciones de las constantes vitales · Exámenes físicos · Exámenes auditivos · Exámenes oculares · Exámenes neurológicos · Análisis clínicos de laboratorio—

Countries

Spain

Outcome results

None listed

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