Phase 2 Safety Study of Pegylated Interferon Lambda plus single or 2 Direct Antiviral Agents with Ribarviri

Phase 1

• Conditions: Chronic Hepatitis CHepatitis C Crónica; MedDRA version: 14.0Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2010-022568-11-ES
• Lead Sponsor: Bristol Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-11-03
• Study Completion: 2014-09-01
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 233

Inclusion Criteria

Hepatitis C crónica (HCC), Genotipo 1;
ARN del VHC > 100.000 UI/ml en la visita de selección;
Seronegativo para VIH y HBsAg;
Biopsia de hígado en los 2 años anteriores; se pueden reclutar sujetos con cirrosis compensada y estos se limitarán a aproximadamente un 10%.
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 158
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Cualquier evidencia de enfermedad hepática distinta a la infección por el VHC;
Coinfección con el VIH;
Diagnóstico o sospecha de carcinoma hepatocelular;
Antecedentes médicos o anomalías de laboratorio que impidan el uso de pegIFN?;-2a o RBV.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified