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| ID | Type | Description | Link |
|---|---|---|---|
| 64294178HPC2001 | Other Identifier | Janssen Research & Development, LLC | |
| 2015-004200-38 | EudraCT Number |
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The purpose of this study is to evaluate the efficacy (proportion of subjects with SVR12), safety, tolerability and pharmacokinetics of an 8- and 6-week treatment regimen of AL-335, odalasvir (ODV) and simeprevir (SMV) in chronic HCV genotype 1, 2, 4, 5 or 6 infected subjects without cirrhosis.
This is a Phase 2b multicenter study. The study will include a screening period of maximum 6 weeks, a treatment period of 6 or 8 weeks and a 24-weeks post-treatment follow-up period. The total study duration for each subject will be 36 to 38 weeks. This study investigates a 3 direct-acting antiviral agent (DAA) combination of AL-335 (HCV NS5B inhibitor), odalasvir (ODV) (a second generation HCV NS5A inhibitor) and simeprevir (SMV) (HCV NS3A4 protease inhibitor). The results of this study will enable the selection of treatment and duration to be further developed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | AL-335 (800 mg), odalasvir (25 mg) and simeprevir (75 mg) once daily during 6 weeks. |
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| Group B | Experimental | AL-335 (800 mg), odalasvir (25 mg) and simeprevir (75 mg) once daily during 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AL-335 | Drug | AL-335 800 mg (2*400) tablet will be administered once daily. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12) | The SVR 12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable 12 weeks after actual EOT. | Week 12 (Follow-Up Phase) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Treatment (SVR24) | The SVR24 was defined as HCV RNA \ | Week 24 (Follow-Up Phase) |
| Number of Participants With Viral Relapse |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antwerp | Belgium | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 6 Weeks | Participants received AL-335 800 milligram (mg) (2*400) tablets, Odalasvir (ODV) 25 mg tablet, and Simeprevir (SMV) 75 mg capsule once daily (qd) orally in the morning for 6 weeks. |
| FG001 | Arm B: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 8 Weeks |
| 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 |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 10, 2017 | Aug 6, 2018 |
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| Odalasvir | Drug | Odalasvir 25 mg tablet will be administered once daily. |
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| Simeprevir | Drug | Simeprevir 75 mg capsule will be administered once daily. |
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Viral Relapse: Participants who did not achieve SVR12, with HCV RNA <LLOQ 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) |
| Number of Participants With Late Viral Relapse | Late Viral Relapse: Participants who achieved SVR12 but had confirmed HCV RNA>=LLOQ afterwards during follow-up. | Up to Week 24 (Follow-up Phase) |
| Percentage of Participants With On-treatment Failure | On-treatment failure: Participants who did not achieve SVR12 and with confirmed HCV RNA>=LLOQ at the End of Treatment (EOT). | EOT up to Week 12 (Follow up Phase) |
| Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Treatment (EOT) | The SVR 4 was defined as participants were considered to have reached SVR4, if 4 weeks after the actual EOT, HCV RNA was \ | Week 4 (Follow-Up Phase) |
| Brussels |
| Belgium |
| Edegem | Belgium |
| Ghent | Belgium |
| Kortrijik | Belgium |
| Leuven | Belgium |
| Vancouver | British Columbia | Canada |
| Victoria | British Columbia | Canada |
| Toronto | Ontario | Canada |
| Vaughan | Ontario | Canada |
| Monteral | Quebec | Canada |
| Montreal | Quebec | Canada |
| Berlin | Germany |
| Essen | Germany |
| Frankfurt | Germany |
| Hamburg | Germany |
| Leipzig | Germany |
| Lodz | Poland |
| Lublin | Poland |
| Mysłowice | Poland |
| Warsaw | Poland |
| Wroclaw | Poland |
| Singapore | Singapore |
| Barcelona | Spain |
| Madrid | Spain |
| Málaga | Spain |
| Seville | Spain |
| Valencia | Spain |
Participants received AL-335 800 milligram (mg) (2*400) tablets, Odalasvir (ODV) 25 mg tablet, and Simeprevir (SMV) 75 mg capsule once daily (qd) orally in the morning for 8 weeks. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 6 Weeks | Participants received AL-335 800 milligram (mg) (2*400) tablets, Odalasvir (ODV) 25 mg tablet, and Simeprevir (SMV) 75 mg capsule once daily (qd) orally in the morning for 6 weeks. |
| BG001 | Arm B: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 8 Weeks | Participants received AL-335 800 milligram (mg) (2*400) tablets, Odalasvir (ODV) 25 mg tablet, and Simeprevir (SMV) 75 mg capsule once daily (qd) orally in the morning for 8 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 | Median | Full Range | years |
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| Sex: Female, Male | 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 | Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12) | The SVR 12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable 12 weeks after actual EOT. | Intent-To-Treat (ITT) population included all randomized participants who took at least 1 dose of the study drug [that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)]. | 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 After End of Treatment (SVR24) | The SVR24 was defined as HCV RNA \ | ITT population included all randomized participants who took at least 1 dose of the study drug (i.e., AL-335, ODV or SMV). Last Observation Carried Forward (LOCF) method was used to impute the missing values. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Week 24 (Follow-Up Phase) |
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| Secondary | Number of Participants With Viral Relapse | Viral Relapse: Participants who did not achieve SVR12, with HCV RNA <LLOQ at the EOT and confirmed HCV RNA greater than or equal to (>=) LLOQ during follow-up. | ITT population included all randomized participants who took at least 1 dose of the study drug (i.e, AL-335, ODV or SMV). | Posted | Number | Participants | End of Treatment up to Week 24 (Follow up phase) |
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| Secondary | Number of Participants With Late Viral Relapse | Late Viral Relapse: Participants who achieved SVR12 but had confirmed HCV RNA>=LLOQ afterwards during follow-up. | ITT population included all randomized participants who took at least 1 dose of the study drug (i.e, AL-335, ODV or SMV). | Posted | Number | Participants | Up to Week 24 (Follow-up Phase) |
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| Secondary | Percentage of Participants With On-treatment Failure | On-treatment failure: Participants who did not achieve SVR12 and with confirmed HCV RNA>=LLOQ at the End of Treatment (EOT). | ITT population included all randomized participants who took at least 1 dose of the study drug (i.e, AL-335, ODV or SMV). | Posted | Number | Percentage of Participants | EOT up to Week 12 (Follow up Phase) |
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| Secondary | Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Treatment (EOT) | The SVR 4 was defined as participants were considered to have reached SVR4, if 4 weeks after the actual EOT, HCV RNA was \ | ITT population included all randomized participants who took at least 1 dose of the study drug (i.e, AL-335, ODV or SMV). | Posted | Number | 95% Confidence Interval | Percentage of Participants | Week 4 (Follow-Up Phase) |
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Screening up to Follow-up (Week 24)
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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 | Arm A: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 6 Weeks | Participants received AL-335 800 milligram (mg) (2*400) tablets, Odalasvir (ODV) 25 mg tablet, and Simeprevir (SMV) 75 mg capsule once daily (qd) orally in the morning for 6 weeks. | 0 | 183 | 7 | 183 | 83 | 183 |
| EG001 | Arm B: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 8 Weeks | Participants received AL-335 800 milligram (mg) (2*400) tablets, Odalasvir (ODV) 25 mg tablet, and Simeprevir (SMV) 75 mg capsule once daily (qd) orally in the morning for 8 weeks. | 1 | 182 | 4 | 182 | 85 | 182 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Intestinal Strangulation | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Infective Keratitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
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| Lower Respiratory Tract Infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Benign Breast Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
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| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
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| Ivth Nerve Paresis | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Parkinsonism | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
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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 in writing, such publication will be withheld for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Physician, Medical Department | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 27, 2017 | Aug 6, 2018 | SAP_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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| 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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| Canada |
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| Germany |
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| Spain |
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| Italy |
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| Poland |
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| Singapore |
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