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Efectos de la administración de ornitina-fenilacetato (OCR-002) en pacientes con cirrosis y hemorragia digestiva alta. Effects of the administration of ornithine phenylacetate (OP, OCR-002) in patients with cirrhosis and upper gastrointestinal bleeding

Efectos de la administración de ornitina-fenilacetato (OCR-002) en pacientes con cirrosis y hemorragia digestiva alta. Effects of the administration of ornithine phenylacetate (OP, OCR-002) in patients with cirrhosis and upper gastrointestinal bleeding

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-017819-16-ES
Enrollment
Unknown
Registered
2009-12-15
Start date
2011-08-22
Completion date
Unknown
Last updated
2015-03-02

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

Conditions

Hemorragia digestiva en pacientes con cirrosis hepática MedDRA version: 13.1 Level: LLT Classification code 10019543 Term: Hemorrhage gastrointestinal System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 13.1 Level: PT Classification code 10019641 Term: Hepatic cirrhosis System Organ Class: 10019805 - Hepatobiliary disorders

Interventions

Product Name: ornitina-fenilacetato Pharmaceutical Form: Solution for injection CAS Number: 952154-79-9 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number

Sponsors

Juan Cordoba
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: a) Cirrosis hepática. b) Hemorragia digestiva iniciada en las 48 horas previas a la inclusión 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Enfermedad terminal (pej. hepatocarcinoma avanzado). - Necesidad de medidas intensivas (ventilación asistida, soporte vasoactivo, hemodiálisis).

Design outcomes

Primary

MeasureTime frame
Main Objective: Evaluar la eficacia del fármaco experimental para reducir la concentración plasmática de amoníaco que sigue a una hemorragia digestiva en pacientes con cirrosis hepática;Secondary Objective: Evaluar el desarrollo de encefalopatía hepática e infecciones bacterianas. Conocer el metabolismo de aminoacidos;Primary end point(s): Concentración de amoníaco venosa durante la duración del estudio—

Countries

Spain

Outcome results

None listed

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