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)

Chronic Hepatitis C Virus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01852604
• Other study ID #: 1894-005
• Secondary ID: IDX-06A-005
• Status: Completed
• Phase: Phase 2
• First received: May 6, 2013
• Last updated: April 22, 2015
• Start date: March 2013
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C Virus
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Samatasvir
Samatasvir (IDX719) will be supplied as 25 mg and 50 mg oral tablets.
• Simeprevir
Simeprevir will be supplied as 75 and 150 mg oral capsules.
• Ribavirin (RBV)
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
TMC647055 will be supplied as 150 mg oral capsules.
• Ritonavir (RTV)
Ritonavir will be supplied as 80 mg/mL oral solution.

Biological:
• Pegylated interferon (Peg-IFN)
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.

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.	Janssen Research & Development, LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants who experienced an adverse event (AE)		Up to approximately 95 weeks	Yes
Primary	Percentage of participants who experienced a serious adverse event (SAE)		Up to approximately 95 weeks	Yes
Primary	Percentage of participants who experienced a Grade 1-4 laboratory abnormality		Up to 66 weeks	Yes
Primary	Percentage of participants who experienced sustained virologic response 4 weeks after the end of treatment (SVR4)		Up to 16 weeks	No
Secondary	Percentage of participants who experienced rapid virologic response (RVR)		Week 4	No
Secondary	Percentage of participants who experienced early virologic response (EVR)		Week 12	No
Secondary	Percentage of participants who experienced sustained virologic response 8 weeks after the end of treatment (SVR8)		Up to 20 weeks	No
Secondary	Percentage of participants who experienced sustained virologic response 12 weeks after the end of treatment (SVR12)		Up to 24 weeks	No
Secondary	Percentage of participants who experienced sustained virologic response 24 weeks after the end of treatment (SVR24)		Up to 36 weeks	No
Secondary	Pharmacokinetic Parameter:Area under the concentration-time curve from time zero to t		Days 1, 4, 7, 10, 14, 21, 28, 42, 56 and 84	No
Secondary	Pharmacokinetic Parameter: Maximum observed drug concentration (Cmax)		Days 1, 4, 7, 10, 14, 21, 28, 42, 56 and 84	No
Secondary	Pharmacokinetic Parameter: Trough drug concentration (Ctrough)		Days 1, 4, 7, 10, 14, 21, 28, 42, 56 and 84	No