Status:
COMPLETED
Samatasvir (IDX719) in Combinations With Simeprevir and/or TMC647055/Ritonavir With or Without Ribavirin for 12 Weeks in Participants With Chronic Hepatitis C Infection (MK-1894-005)
Lead Sponsor:
Merck Sharp & Dohme LLC
Collaborating Sponsors:
Janssen Research & Development, LLC
Conditions:
Chronic Hepatitis C Virus
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Parts A and B of this study are designed to evaluate the safety, tolerability, efficacy and pharmacokinetic profiles of samatasvir and simeprevir when administered in combination with ribavirin (RBV) ...
Detailed Description
Part A of this study is randomized and double-blind. Parts B and C are randomized and open-label.
Eligibility Criteria
Inclusion
- Must have Genotype 1a, 1b, 4 or 6 HCV infection.
- Documented clinical history compatible with chronic hepatitis C
- HCV treatment-naïve or interferon/RBV-treatment relapsed (Part C)
- Must agree to use an acceptable double method of birth control (one of which must be a barrier method) for at least 6 months after the last dose of study drugs.
Exclusion
- Female participants who are pregnant or breastfeeding.
- Body Mass Index (BMI) \> 36 kg/m2.
- Co-infected with hepatitis B virus or human immunodeficiency virus (HIV).
- History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC.
- History or signs of decompensated liver disease: ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or other clinical signs of portal hypertension or hepatic insufficiency.
- Has one or more known primary or secondary causes of liver disease, other than hepatitis C
- History of, or active, acute or chronic, liver or biliary injury due to drugs, toxins, non-HCV viral hepatitis, gallstones or other etiologies
- Donated blood or had significant blood loss 30 days prior to dosing
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT01852604
Start Date
March 1 2013
End Date
April 1 2015
Last Update
April 23 2015
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