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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)

Primary Purpose

Chronic Hepatitis C Virus

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Samatasvir

Simeprevir

Ribavirin (RBV)

TMC647055

Ritonavir (RTV)

Pegylated interferon (Peg-IFN)

Samatasvir matching placebo

About this trial

This is an interventional treatment trial for Chronic Hepatitis C Virus focused on measuring HCV, Hepatitis C, chronic hepatitis C, antiviral

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Arm Label

Part A: GT 1b, 4 - samatasvir 50/simeprevir/RBV

Part A: GT 1b, 4 - samatasvir 100/simeprevir/RBV

Part A: GT 1b, 4 - samatasvir 150/simeprevir/RBV

Part B: GT 1b, 4 - samatasvir 25/simeprevir/RBV

Part B: GT 1b, 4 - samatasvir 100/simeprevir/RBV

Part B: GT 6 - samatasvir 100/simeprevir/RBV

Part C: GT 1a, 1b - samatasvir 50/simeprevir/TCM647055/RTV

Part C: GT 1a, 1b - samatasvir 50/simeprivir/TCM647055/RTV/RBV

Arm Description

Part A: Participants with genotype 1b or 4 received samatasvir 50 mg and samatasvir matching placebo once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks

Part A: Participants with genotype 1b or 4 received samatasvir 100 mg and samatasvir matching placebo once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks

Part A: Participants with genotype 1b or 4 received samatasvir 150 mg once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks

Part B: Participants with genotype 1b or 4 received samatasvir 25 mg once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks

Part B: Participants with genotype 1b or 4 received samatasvir 100 mg once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks

Part B: Participants with Genotype 6 received samatasvir 100 mg once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks

Part C: Participants with Genotype 1a or 1b received samatasvir 50 mg once daily, plus simeprevir 75 mg capsule once daily, plus TMC647055 450 mg once daily plus RTV 30 mg once daily for 12 weeks

Part C: Participants with Genotype 1a or 1b received samatasvir 50 mg once daily, plus simeprevir 75 mg capsule once daily, plus TMC647055 450 mg once daily, plus RTV 30 mg once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks

Outcomes

Primary Outcome Measures

Percentage of participants who experienced an adverse event (AE)

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

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

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

Secondary Outcome Measures

Percentage of participants who experienced rapid virologic response (RVR)

Percentage of participants who experienced early virologic response (EVR)

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

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

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

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

Pharmacokinetic Parameter: Maximum observed drug concentration (Cmax)

Pharmacokinetic Parameter: Trough drug concentration (Ctrough)

Full Information

NCT ID

NCT01852604

First Posted

May 6, 2013

Last Updated

April 22, 2015

Sponsor

Merck Sharp & Dohme LLC

Collaborators

Janssen Research & Development, LLC

1. Study Identification

Unique Protocol Identification Number

NCT01852604

Brief Title

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

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

March 2013 (undefined)

Primary Completion Date

April 2015 (Actual)

Study Completion Date

April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

Collaborators

Janssen Research & Development, LLC

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis C Virus

Keywords

HCV, Hepatitis C, chronic hepatitis C, antiviral

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

143 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part A: GT 1b, 4 - samatasvir 50/simeprevir/RBV

Arm Type

Experimental

Arm Description

Arm Title

Part A: GT 1b, 4 - samatasvir 100/simeprevir/RBV

Arm Type

Experimental

Arm Description

Arm Title

Part A: GT 1b, 4 - samatasvir 150/simeprevir/RBV

Arm Type

Experimental

Arm Description

Arm Title

Part B: GT 1b, 4 - samatasvir 25/simeprevir/RBV

Arm Type

Experimental

Arm Description

Arm Title

Part B: GT 1b, 4 - samatasvir 100/simeprevir/RBV

Arm Type

Experimental

Arm Description

Arm Title

Part B: GT 6 - samatasvir 100/simeprevir/RBV

Arm Type

Experimental

Arm Description

Arm Title

Part C: GT 1a, 1b - samatasvir 50/simeprevir/TCM647055/RTV

Arm Type

Experimental

Arm Description

Part C: Participants with Genotype 1a or 1b received samatasvir 50 mg once daily, plus simeprevir 75 mg capsule once daily, plus TMC647055 450 mg once daily plus RTV 30 mg once daily for 12 weeks

Arm Title

Part C: GT 1a, 1b - samatasvir 50/simeprivir/TCM647055/RTV/RBV

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Samatasvir

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Simeprevir

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Ribavirin (RBV)

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

TMC647055

Intervention Description

TMC647055 will be supplied as 150 mg oral capsules.

Intervention Type

Drug

Intervention Name(s)

Ritonavir (RTV)

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Pegylated interferon (Peg-IFN)

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Samatasvir matching placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage of participants who experienced an adverse event (AE)

Time Frame

Up to approximately 95 weeks

Title

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

Time Frame

Up to approximately 95 weeks

Title

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

Time Frame

Up to 66 weeks

Title

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

Time Frame

Up to 16 weeks

Secondary Outcome Measure Information:

Title

Percentage of participants who experienced rapid virologic response (RVR)

Time Frame

Week 4

Title

Percentage of participants who experienced early virologic response (EVR)

Time Frame

Week 12

Title

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

Time Frame

Up to 20 weeks

Title

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

Time Frame

Up to 24 weeks

Title

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

Time Frame

Up to 36 weeks

Title

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

Title

Pharmacokinetic Parameter: Maximum observed drug concentration (Cmax)

Time Frame

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

Title

Pharmacokinetic Parameter: Trough drug concentration (Ctrough)

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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)

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