EU: A Multicenter Compassionate Use Program of Daclatasvir (BMS-790052) in Combination With Sofosbuvir With or Without Ribavirin for the Treatment of Subjects With Chronic Hepatitis C
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The primary objective of this program is to provide Daclatasvir in combination with Sofosbuvir with or without Ribavirin to subjects with chronic Hepatitis C who are at a high risk of liver decompensation or death within 12 months if left untreated and who have no available therapeutic options.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
This program is conducted in the EU (Germany, Austria, Norway, The Netherlands, Sweden and United Kingdom only)
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Patients chronically infected with Hepatitis C
Patients at a high risk of liver decompensation or death within 12 months if left untreated and who have no available therapeutic options
Patients who are <18 years old
Patients who have contraindications to either Daclatasvir (DCV) or Sofosbuvir (SOF)
Patients who are pregnant
Creatinine clearance (CrCl) ≤ 30 mL/min (as estimated by Cockcroft and Gault formula)
Patients who are pregnant or Women of Child Bearing Potential who are not using required contraception