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| ID | Type | Description | Link |
|---|---|---|---|
| 64294178HPC2003 | Other Identifier | Janssen Pharmaceutical K.K., Japan |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (Chronic Hepatitis C Without Cirrhosis) | Experimental | Participants will receive 800 milligram (mg) AL-335 +odalasvir (ODV) 25 mg+simeprevir (SMV) 75 mg once daily for 8 weeks in Cohort 1. |
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| Cohort 2 (Chronic Hepatitis C With Compensated Cirrhosis) | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AL-335 | Drug | Participants will receive AL-335 800 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Week 4 (follow-up phase) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K., Japan Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amagasaki-shi | Japan | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Chronic Hepatitis C Without Cirrhosis | Participants received AL-335 800 milligram (mg) (2*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks. |
| FG001 | Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 8, 2018 | May 3, 2019 |
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| Odalasvir (ODV) | Drug | Participants will receive ODV 25 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2. |
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| Simeprevir (SMV) | Drug | Participants will receive SMV 75 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2. |
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| 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. | Week 12 (follow-up phase) |
| 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. | Week 24 (follow-up phase) |
| 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. | End of treatment up to Week 24 (follow up phase) |
| 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. | EOT up to Week 12 (follow up phase) |
| 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. | Day 2, Day 3, Week 1, 2, 3, 4, 6, 8 (for Cohort 1), 10, and 12 (for Cohort 2 only) |
| Time to Achieve HCV RNA Not Detected or HCV RNA <LLOQ | Time to Achieve HCV RNA not Detected or HCV RNA \ | EOT up to Week 24 (follow up phase) |
| 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 |
Participants received AL-335 800 mg (2*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Chronic Hepatitis C Without Cirrhosis | Participants received AL-335 800 milligram (mg) (2*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks. |
| BG001 | Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis | Participants received AL-335 800 mg (2*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The safety analysis set included all enrolled participants who received at least 1 dose of study drug. | Posted | Number | participants | Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2) |
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| Secondary | 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). | Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, ODV or SMV) and had at least 1 postbaseline efficacy measurement in this study. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 4 (follow-up phase) |
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| Secondary | 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. | Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, ODV or SMV) and had at least 1 postbaseline efficacy measurement in this study. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 12 (follow-up phase) |
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| Secondary | 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. | Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, ODV or SMV) and had at least 1 postbaseline efficacy measurement in this study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 24 (follow-up phase) |
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| Secondary | 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. | Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)] and had at least 1 postbaseline efficacy measurement in this study. | Posted | Number | Percentage of participants | End of treatment up to Week 24 (follow up phase) |
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| Secondary | 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. | Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, ODV or SMV) and had at least 1 postbaseline efficacy measurement in this study. | Posted | Number | Percentage of Participants | EOT up to Week 12 (follow up phase) |
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| Secondary | 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. | Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, ODV or SMV) and had at least 1 postbaseline efficacy measurement in this study. | Posted | Number | Percentage of participants | Day 2, Day 3, Week 1, 2, 3, 4, 6, 8 (for Cohort 1), 10, and 12 (for Cohort 2 only) |
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| Secondary | Time to Achieve HCV RNA Not Detected or HCV RNA <LLOQ | Time to Achieve HCV RNA not Detected or HCV RNA \ | Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, ODV or SMV) and had at least 1 postbaseline efficacy measurement in this study. | Posted | Mean | Standard Deviation | Days | EOT up to Week 24 (follow up phase) |
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Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2)
Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)].
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: Chronic Hepatitis C Without Cirrhosis | Participants received AL-335 800 milligram (mg) (2*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks. | 0 | 22 | 0 | 22 | 15 | 22 |
| EG001 | Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis | Participants received AL-335 800 mg (2*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks. | 0 | 11 | 1 | 11 | 9 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA Version 20.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular Block First Degree | Cardiac disorders | MedDRA Version 20.0 | Non-systematic Assessment |
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| Supraventricular Extrasystoles | Cardiac disorders | MedDRA Version 20.0 | Non-systematic Assessment |
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| Cataract | Eye disorders | MedDRA Version 20.0 | Non-systematic Assessment |
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| Eye Discharge | Eye disorders | MedDRA Version 20.0 | Non-systematic Assessment |
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| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
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| Gastrointestinal Motility Disorder | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
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| Malaise | General disorders | MedDRA Version 20.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
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| Oral Herpes | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
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| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
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| Alanine Aminotransferase Increased | Investigations | MedDRA Version 20.0 | Non-systematic Assessment |
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| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 20.0 | Non-systematic Assessment |
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| Blood Cholesterol Increased | Investigations | MedDRA Version 20.0 | Non-systematic Assessment |
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| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
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| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
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| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
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As the sponsor decided to discontinue the development of JNJ-64294178, the study enrollment to reach the target number of participants was not completed in Cohort 2.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Leader | Janssen Pharmaceutical K.K., Japan | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jul 27, 2017 | Sep 10, 2019 | Prot_001.pdf |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000629483 | adafosbuvir |
| C000629482 | odalasvir |
| D000069616 | Simeprevir |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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