Skip to main content
OpenTrials
Completed

NCT Number: 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)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Hepatitis C Virus Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Samatasvir

Drug

Samatasvir (IDX719) will be supplied as 25 mg and 50 mg oral tablets.

Simeprevir

Drug

Simeprevir will be supplied as 75 and 150 mg oral capsules.

ribavirin (RBV)

Drug

Ribavirin will be supplied as 200 mg oral tablets. Participants in the RBV-free arms experiencing non-response or virologic breakthrough during the treatment period will be offered RBV dosed according to the product label as an add-on to the participant's randomized treatment assignment.

TMC647055

Drug

TMC647055 will be supplied as 150 mg oral capsules.

Ritonavir (RTV)

Drug

Ritonavir will be supplied as 80 mg/mL oral solution.

Pegylated interferon (Peg-IFN)

Biological

Participants experiencing non-response or virologic breakthrough during the treatment period will be offered Peg-IFN (subcutaneous injection) dosed according to the product label as an add-on to the participant's randomized treatment assignment.

Samatasvir matching placebo

Other

Samatasvir matching placebo will be supplied for the 50 mg tablets used in Part A.

Primary outcomes

  1. Percentage of participants who experienced an adverse event (AE)

    Time frame: Up to approximately 95 weeks

  2. Percentage of participants who experienced a serious adverse event (SAE)

    Time frame: Up to approximately 95 weeks

  3. Percentage of participants who experienced a Grade 1-4 laboratory abnormality

    Time frame: Up to 66 weeks

  4. Percentage of participants who experienced sustained virologic response 4 weeks after the end of treatment (SVR4)

    Time frame: Up to 16 weeks

Secondary outcomes

  1. Percentage of participants who experienced rapid virologic response (RVR)

    Time frame: Week 4

  2. Percentage of participants who experienced early virologic response (EVR)

    Time frame: Week 12

  3. Percentage of participants who experienced sustained virologic response 8 weeks after the end of treatment (SVR8)

    Time frame: Up to 20 weeks

  4. Percentage of participants who experienced sustained virologic response 12 weeks after the end of treatment (SVR12)

    Time frame: Up to 24 weeks

  5. Percentage of participants who experienced sustained virologic response 24 weeks after the end of treatment (SVR24)

    Time frame: Up to 36 weeks

  6. Pharmacokinetic Parameter:Area under the concentration-time curve from time zero to t

    Time frame: Days 1, 4, 7, 10, 14, 21, 28, 42, 56 and 84

  7. Pharmacokinetic Parameter: Maximum observed drug concentration (Cmax)

    Time frame: Days 1, 4, 7, 10, 14, 21, 28, 42, 56 and 84

  8. Pharmacokinetic Parameter: Trough drug concentration (Ctrough)

    Time frame: Days 1, 4, 7, 10, 14, 21, 28, 42, 56 and 84

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 14, 2013
Registry last updated
Apr 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.