A Phase 2, Open-Label Study of Daclatasvir (BMS-790052) and TMC435 in Combination With or Without Ribavirin (RBV) For Treatment-Naive Subjects or Null Responders to Prior Peginterferon Alfa (PegIFN)/RBV Therapy With Genotype 1 Chronic Hepatitis C

CompletadoFase 2ClinicalTrials.gov

ID: NCT01628692Tipo: INTERVENTIONALInicio: 1 de jul de 2012Fin estimado: 1 de nov de 2013

Gastroenterología Enfermedades Infecciosas

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to assess the safety and efficacy of daclatasvir and simeprevir with and without ribavirin for genotype 1 chronic hepatitis C virus infection in patients who are treatment-naive or null responders to previous pegylated interferon/ribavirin therapy.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Hepatitis C virus (HCV) genotype 1a or 1b
Males and females, ≥18 years of age
HCV RNA ≥10,000 IU/mL
Participants with compensated cirrhosis are permitted
Advanced fibrosis (F3/F4) is capped at approximately 35% of the total treated population with a minimum of 20% F4 patients
If no cirrhosis, a liver biopsy within 3 years prior to enrollment
If cirrhosis is present, any prior liver biopsy

Criterios de exclusión

Liver or any other transplant (other than cornea and hair)
Evidence of a medical condition contributing to chronic liver disease other than HCV infection
Current or known history of cancer, (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment
Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
Patients infected with HIV or hepatitis B virus
Gastrointestinal disease impacting absorption of study drug
Uncontrolled diabetes or hypertension
Prior exposure to an HCV direct-acting agent
Any criteria that would exclude the patient from receiving ribavirin
Absolute neutrophil count \<1.5\*1,000,000,000 cells/L (\<1.2\*1,000,000,000 cells/L for Black/African Americans)
Platelets \<90\*1,000,000,000 cells/L
Hemoglobin \<12 g/dL for females, \<13 g/dL for males
Alanine aminotransferase ≥5\*upper limit of normal
In patients without cirrhosis, total bilirubin ≥2 mg/dL unless patient has a documented history of Gilbert's disease
In patients with cirrhosis, total bilirubin o ≥1.5 mg/dL
International normalized ratio ≥1.7
QTcF or QTcB \>500 mSec
Creatinine clearance ≤50 mL/min
Alpha fetoprotein (AFP) \>100 ng/mL OR
AFP ≥50 ng/mL and ≤100 ng/mL requiring liver ultrasound
Albumin \<3.5 g/dL

Intervenciones

drug

Daclatasvir

Tablets, oral, 30 mg, once daily

drug

Simeprevir

Capsule, oral, 150 mg, once daily

drug

Ribavirin

Tablets, oral, 500-600 mg, twice daily

Ubicaciones

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

Buenos Aires, Buenos Aires, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

ColaboradorJanssen Research & Development, LLC

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