A Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Participants With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naive
NCT ID: NCT02993250
Last Updated: 2019-09-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
33 participants
INTERVENTIONAL
2016-12-21
2018-05-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1 (Chronic Hepatitis C Without Cirrhosis)
Participants will receive 800 milligram (mg) AL-335 +odalasvir (ODV) 25 mg+simeprevir (SMV) 75 mg once daily for 8 weeks in Cohort 1.
AL-335
Participants will receive AL-335 800 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.
Odalasvir (ODV)
Participants will receive ODV 25 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.
Simeprevir (SMV)
Participants will receive SMV 75 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.
Cohort 2 (Chronic Hepatitis C With Compensated Cirrhosis)
Participants will receive AL-335 800 milligram (mg)+ODV 25 mg+SMV 75 mg once daily for 12 weeks in Cohort 2. Dosing in cohort 2 will be started according to decision of Data Review Committee (DRC).
AL-335
Participants will receive AL-335 800 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.
Odalasvir (ODV)
Participants will receive ODV 25 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.
Simeprevir (SMV)
Participants will receive SMV 75 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.
Interventions
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AL-335
Participants will receive AL-335 800 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.
Odalasvir (ODV)
Participants will receive ODV 25 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.
Simeprevir (SMV)
Participants will receive SMV 75 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* All participants must have HCV genotype 1 or 2 infection, determined at screening
* HCV ribonucleic acid (RNA) plasma levels greater than or equal to (\>=)10,000 international units per Milliliter (IU/mL), determined at screening
* Direct-acting antiviral (DAA)-naive participants, defined as not having received treatment with any approved or investigational DAA drug for chronic HCV infection; prior HCV therapy consisting of interferon (IFN, pegylated or nonpegylated) with or without ribavirin (RBV) is allowed
* Participants without cirrhosis or with compensated cirrhosis
Exclusion Criteria
* Co-infection with human immunodeficiency virus (HIV 1 or HIV 2 antibody positive) or hepatitis B virus (HBV) (hepatitis B surface antigen \[HBsAg\] positive)
* Prior treatment with any investigational or approved HCV DAA, either in combination with PegIFN or IFN free
* Any evidence of liver disease of non-HCV etiology. This includes, but is not limited to, acute hepatitis A infection (immunoglobulin M), drug or alcohol related liver disease, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha 1 antitrypsin deficiency, primary biliary cirrhosis, or any other non-HCV liver disease that is considered clinically significant by the investigator
* Evidence of hepatic decompensation as assessed with Child-Pugh Class B or C or any of the following: history or current clinical evidence of ascites, bleeding varices, or hepatic encephalopathy
20 Years
75 Years
ALL
No
Sponsors
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Janssen Pharmaceutical K.K.
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Pharmaceutical K.K., Japan Clinical Trial
Role: STUDY_DIRECTOR
Janssen Pharmaceutical K.K.
Locations
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Amagasaki-shi, , Japan
Bunkyō City, , Japan
Hiroshima, , Japan
Kagoshima, , Japan
Kurume-shi, , Japan
Musashino-shi, , Japan
Nagoya, , Japan
Omura-shi, , Japan
Osaka, , Japan
Saitama, , Japan
Sakaishi, , Japan
Sapporo, , Japan
Suita-shi, , Japan
Yokohama, , Japan
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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64294178HPC2003
Identifier Type: OTHER
Identifier Source: secondary_id
CR108264
Identifier Type: -
Identifier Source: org_study_id
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