Back to resultsA 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
Primary Purpose
Hepatitis C, Chronic
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
AL-335
Odalasvir (ODV)
Simeprevir (SMV)
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C, Chronic
Eligibility Criteria
Inclusion Criteria:
- Chronic hepatitis C virus (HCV) infection
- 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:
- Infection with HCV genotype - 3, 4, 5, or 6
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cohort 1 (Chronic Hepatitis C Without Cirrhosis)
Cohort 2 (Chronic Hepatitis C With Compensated Cirrhosis)
Arm Description
Participants will receive 800 milligram (mg) AL-335 +odalasvir (ODV) 25 mg+simeprevir (SMV) 75 mg once daily for 8 weeks in Cohort 1.
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).
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events (AEs)
An adverse event was any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Secondary Outcome Measures
Percentage of Participants With Sustained Virologic Response 4 Weeks (SVR4) After Actual End-of-Treatment
SVR4 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detected or not detected at 4 weeks after the actual End-of-treatment (EOT).
Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) After Actual End-of-treatment
SVR12 was defined as HCV RNA < LLOQ (15 IU/mL) detected or not detected at 12 weeks after the actual EOT.
Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) After Actual End-of-treatment
SVR 24 was defined as HCV RNA < LLOQ (15 IU/mL) detected or not detected at 24 weeks after the actual EOT.
Percentage of Participants With Viral Relapse
Viral relapse was defined as participants who did not achieve SVR12, with HCV RNA < LLOQ (15 IU/mL) at the EOT and confirmed HCV RNA greater than or equal to (>=) LLOQ during follow-up.
Percentage of Participants With On-treatment Failure
On-treatment failure was defined as participants who did not achieve SVR12, with confirmed HCV RNA >= LLOQ (15 IU/mL) at the actual EOT.
Percentage of Participants With On-treatment Virologic Response
Percentage of participants with On-treatment Virologic Response with HCV RNA < LLOQ (15 IU/mL), not detected at specified time points during treatment were reported.
Time to Achieve HCV RNA Not Detected or HCV RNA <LLOQ
Time to Achieve HCV RNA not Detected or HCV RNA <LLOQ (15 IU/mL) was reported.
Full Information
NCT ID
NCT02993250
First Posted
December 13, 2016
Last Updated
September 10, 2019
Sponsor
Janssen Pharmaceutical K.K.
1. Study Identification
Unique Protocol Identification Number
NCT02993250
Brief Title
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
Official Title
A Phase 2a, Multicenter, Open-label Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Subjects With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naïve
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
December 21, 2016 (Actual)
Primary Completion Date
May 7, 2018 (Actual)
Study Completion Date
May 7, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Pharmaceutical K.K.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main purpose of this study is to evaluate the safety and tolerability of a combination treatment of AL-335, odalasvir (ODV), and simeprevir (SMV) for 8 weeks in Japanese participants with genotype 1 or 2 chronic hepatitis C virus (HCV) infection without cirrhosis and for 12 weeks in direct-acting antiviral (DAA)-naive Japanese participants with genotype 1 or 2 chronic HCV infection with compensated cirrhosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1 (Chronic Hepatitis C Without Cirrhosis)
Arm Type
Experimental
Arm Description
Participants will receive 800 milligram (mg) AL-335 +odalasvir (ODV) 25 mg+simeprevir (SMV) 75 mg once daily for 8 weeks in Cohort 1.
Arm Title
Cohort 2 (Chronic Hepatitis C With Compensated Cirrhosis)
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
AL-335
Other Intervention Name(s)
JNJ-64146212
Intervention Description
Participants will receive AL-335 800 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.
Intervention Type
Drug
Intervention Name(s)
Odalasvir (ODV)
Other Intervention Name(s)
JNJ-64289901
Intervention Description
Participants will receive ODV 25 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.
Intervention Type
Drug
Intervention Name(s)
Simeprevir (SMV)
Other Intervention Name(s)
TMC435
Intervention Description
Participants will receive SMV 75 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs)
Description
An adverse event was any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time Frame
Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response 4 Weeks (SVR4) After Actual End-of-Treatment
Description
SVR4 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detected or not detected at 4 weeks after the actual End-of-treatment (EOT).
Time Frame
Week 4 (follow-up phase)
Title
Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) After Actual End-of-treatment
Description
SVR12 was defined as HCV RNA < LLOQ (15 IU/mL) detected or not detected at 12 weeks after the actual EOT.
Time Frame
Week 12 (follow-up phase)
Title
Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) After Actual End-of-treatment
Description
SVR 24 was defined as HCV RNA < LLOQ (15 IU/mL) detected or not detected at 24 weeks after the actual EOT.
Time Frame
Week 24 (follow-up phase)
Title
Percentage of Participants With Viral Relapse
Description
Viral relapse was defined as participants who did not achieve SVR12, with HCV RNA < LLOQ (15 IU/mL) at the EOT and confirmed HCV RNA greater than or equal to (>=) LLOQ during follow-up.
Time Frame
End of treatment up to Week 24 (follow up phase)
Title
Percentage of Participants With On-treatment Failure
Description
On-treatment failure was defined as participants who did not achieve SVR12, with confirmed HCV RNA >= LLOQ (15 IU/mL) at the actual EOT.
Time Frame
EOT up to Week 12 (follow up phase)
Title
Percentage of Participants With On-treatment Virologic Response
Description
Percentage of participants with On-treatment Virologic Response with HCV RNA < LLOQ (15 IU/mL), not detected at specified time points during treatment were reported.
Time Frame
Day 2, Day 3, Week 1, 2, 3, 4, 6, 8 (for Cohort 1), 10, and 12 (for Cohort 2 only)
Title
Time to Achieve HCV RNA Not Detected or HCV RNA <LLOQ
Description
Time to Achieve HCV RNA not Detected or HCV RNA <LLOQ (15 IU/mL) was reported.
Time Frame
EOT up to Week 24 (follow up phase)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic hepatitis C virus (HCV) infection
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:
Infection with HCV genotype - 3, 4, 5, or 6
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Pharmaceutical K.K., Japan Clinical Trial
Organizational Affiliation
Janssen Pharmaceutical K.K.
Official's Role
Study Director
Facility Information:
City
Amagasaki-shi
Country
Japan
City
Bunkyo-ku
Country
Japan
City
Hiroshima-shi
Country
Japan
City
Kagoshima-shi
Country
Japan
City
Kurume-shi
Country
Japan
City
Musashino-shi
Country
Japan
City
Nagoya-shi
Country
Japan
City
Omura-shi
Country
Japan
City
Osaka-shi
Country
Japan
City
Saitama
Country
Japan
City
Sakai-shi
Country
Japan
City
Sapporo-shi
Country
Japan
City
Suita-shi
Country
Japan
City
Yokohama-shi
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
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
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