Phase3 Study to Evaluate the Efficacy and Safety of AlbuminInterferon in Combination With Ribavirin Compared With Peginterferon in Combination With Ribavirin in Interferon Alfa Naive Subjects With CHC Genotype 2/3.

CompletadoFase 3ClinicalTrials.gov

ID: NCT00411385Tipo: INTERVENTIONALInicio: 1 de feb de 2007Fin estimado: 1 de oct de 2008

Gastroenterología Enfermedades Infecciosas

Traducción no disponible, mostrando original

Resumen

This is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of albumin interferon alfa-2b (alb-IFN)in combination with ribavirin compared with peginterferon alfa-2a (PEGASYS or PEG-IFNa2a) in combination with ribavirin in subjects with chronic hepatitis C, genotype 2/3 who are IFNa treatment naive.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Diagnosis of chronic hepatitis C.
Liver biopsy performed within 2 years of Day 0 or during screening.
Infected with hepatitis C virus genotype 2/3.
Interferon alfa treatment naïve (ie, have never been treated with an interferon product).
Subjects are eligible to enter the study if they (or their partners) are not pregnant or nursing, are sterile, or of non childbearing potential, or are willing to practice abstinence or use appropriate birth control methods during the study and for 7 months after the last dose of ribavirin.
Have compensated liver disease.

Criterios de exclusión

Decompensated liver disease including those subjects with a past history or presence of ascites, bleeding varices or hepatic encephalopathy.
History of moderate, severe or uncontrolled psychiatric disease, especially depression, including a history of hospitalization or prior suicidal attempt.
Positive for human immunodeficiency virus (HIV-1) or hepatitis B surface antigen (HBsAG).
Clinical diagnosis of other causes of chronic liver disease including but not limited to hepatitis B, autoimmune hepatitis, primary biliary cirrhosis, alcoholic liver disease, hemochromatosis, Wilson's Disease, or alpha 1-antitrypsin deficiency.
A history of immunologically mediated disease (eg, rheumatoid arthritis, inflammatory bowel disease, moderate/severe psoriasis, sarcoidosis, systemic lupus erythematosus).
Active seizure disorder within the last 2 years.
Organ transplant other than cornea and hair transplant.
Clinically significant hemoglobinopathy (eg, thalassemia, sickle cell anemia).
Cancer within the last 5 years(with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix).
Drug or alcohol addiction within the last 6 months. Subjects in a supervised methadone treatment program may be enrolled in the study.
Received any experimental agent within 28 days prior to Day 0.

Intervenciones

drug

albumin interferon alfa-2b

900 and 1200 micrograms Albumin Interferon Alpha 2a given subcutaneously once every two weeks for 24 weeks

drug

peginterferon alfa-2a

180 micrograms Pegasys given subcutaneaously once a week for 24 weeks

drug

Ribavirin

800mg/day for 24 weeks

Ubicaciones

Unidad de Hepatología

Capital Federal, Buenos Aires, Argentina

Fundación Cidea

Capital Federal, Buenos Aires, Argentina

Hospital Italiano

Capital Federal, Buenos Aires, Argentina

Hospital Universitario Austral

Pilar, Buenos Aires, Argentina

Htal Pcial del Centenario

Rosario, Santa Fe Province, Argentina

Patrocinadores

PrincipalHuman Genome Sciences Inc.

ColaboradorNovartis

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