Clinical trial NCT01852604: 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)
Official title: A Randomized Study to Evaluate the Safety and Efficacy of IDX719 in Combinations With Simeprevir and/or TMC647055/Ritonavir With or Without Ribavirin for 12 Weeks in Subjects With Chronic Hepatitis C Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C Virus
Keywords: HCV
Hepatitis C
chronic hepatitis C
antiviral
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2013-05-14
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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) for 12 weeks in treatment-naïve, Genotype (GT) 1b, 4 and 6 hepatitic C virus (HCV)-infected participants.

Part C of this study is designed to evaluate the safety, tolerability, efficacy and pharmacokinetic profiles of samatasvir, simeprevir, TMC647055 and ritonavir (RTV) when administered in combination with or without RBV for 12 weeks in treatment-naïve or interferon/RBV-treatment relapsed, GT 1a and 1b HCV-infected participants.

Detailed description: Part A of this study is randomized and double-blind. Parts B and C are randomized and open-label.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Percentage of participants who experienced an adverse event (AE)
timeFrame: Up to approximately 95 weeks
measure: Percentage of participants who experienced a serious adverse event (SAE)
timeFrame: Up to approximately 95 weeks
measure: Percentage of participants who experienced a Grade 1-4 laboratory abnormality
timeFrame: Up to 66 weeks
measure: Percentage of participants who experienced sustained virologic response 4 weeks after the end of treatment (SVR4)
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: Percentage of participants who experienced rapid virologic response (RVR)
timeFrame: Week 4
measure: Percentage of participants who experienced early virologic response (EVR)
timeFrame: Week 12
measure: Percentage of participants who experienced sustained virologic response 8 weeks after the end of treatment (SVR8)
timeFrame: Up to 20 weeks
measure: Percentage of participants who experienced sustained virologic response 12 weeks after the end of treatment (SVR12)
timeFrame: Up to 24 weeks
measure: Percentage of participants who experienced sustained virologic response 24 weeks after the end of treatment (SVR24)
timeFrame: Up to 36 weeks
measure: Pharmacokinetic Parameter:Area under the concentration-time curve from time zero to t
timeFrame: Days 1, 4, 7, 10, 14, 21, 28, 42, 56 and 84
measure: Pharmacokinetic Parameter: Maximum observed drug concentration (Cmax)
timeFrame: Days 1, 4, 7, 10, 14, 21, 28, 42, 56 and 84
measure: Pharmacokinetic Parameter: Trough drug concentration (Ctrough)
timeFrame: Days 1, 4, 7, 10, 14, 21, 28, 42, 56 and 84
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: