| ID | Type | Description | Link |
|---|---|---|---|
| TMC435HPC3021 | Other Identifier | Janssen R&D Ireland | |
| 2014-003446-27 | EudraCT Number |
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The purpose of this study is to show superiority of simeprevir (SMV) in combination with sofosbuvir for 12 weeks versus a historical control. Historical control will be a composite of the observed historical sustained virological response at Week 12 (SVR12) rates of SMV in combination with (pegylated) interferon (PegIFN)/ribavirin (RBV) of the subpopulations in study HPC3011 (NCT01567735) and will depend on the percentage of treatment-naive, prior relapser, prior non-responder, interferon (IFN)-intolerant and other subjects enrolled in this study.
This is a Phase 3, open-label (all people know the identity of the intervention), single-arm, multicenter study (conducted at multiple sites). The study consists of 3 periods: a Screening period (up to 4 weeks), Treatment period (12 Weeks) and Post treatment follow-up period (until 24 weeks after end of treatment). The duration of the subjects' participation will be approximately 40 weeks. In the treatment period subjects will receive oral capsule simeprevir along with oral tablet sofosbuvir once daily for 12 weeks. Primarily efficacy will be evaluated as percentage of subjects with sustained virologic response at Week 12 after the end of treatment. Subjects' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simeprevir and Sofosbuvir | Experimental | Subjects will receive oral capsule of Simeprevir 150 milligram (mg) along with oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simeprevir | Drug | Subjects will receive oral capsule of Simeprevir 150 mg, once a day from Day 1 up to Week 12. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12) | SVR12 is defined as the percentage of participants with 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. | 12 weeks after EOT |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Therapy (SVR4) | SVR4 is defined as the percentage of participants with hepatitis C virus ribonucleic acid (HCV RNA) less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable 4 weeks after actual EOT. | 4 weeks after EOT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen R&D Ireland Clinical Trials | Janssen R&D Ireland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Badalona | Spain | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27896822 | Derived | Buti M, Calleja JL, Lens S, Diago M, Ortega E, Crespo J, Planas R, Romero-Gomez M, Rodriguez FG, Pascasio JM, Fevery B, Kurland D, Corbett C, Kalmeijer R, Jessner W. Simeprevir in combination with sofosbuvir in treatment-naive and -experienced patients with hepatitis C virus genotype 4 infection: a Phase III, open-label, single-arm study (PLUTO). Aliment Pharmacol Ther. 2017 Feb;45(3):468-475. doi: 10.1111/apt.13883. Epub 2016 Nov 29. |
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| ID | Title | Description |
|---|---|---|
| FG000 | SMV+SOF 12 Weeks | Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Sofosbuvir | Drug | Subjects will receive oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12. |
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| Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Therapy (SVR24) | Participants were considered to have reached SVR24, if at the time point of SVR24 (that is [i.e.], 24 weeks after the end of treatment [EOT]) the following condition has been met: HCV RNA < lower limit of quantification (LLOQ), i.e., 15 IU/mL, detectable or undetectable. | At 24 weeks after EOT |
| Percentage of Participants With On-treatment Virologic Response of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) | Percentage of participants with HCV RNA less than (<) 15 IU/mL undetectable or detectable or detectable /undetectable at specific time points were observed. | Week 2, 3, 4, 12 and EOT |
| Percentage of Participants With On-Treatment Failure | Participants were considered on-treatment failures if they have at EOT (confirmed) detectable HCV RNA, i.e., <LLOQ detectable or >=LLOQ. | through 12 weeks (EOT) |
| Percentage of Participants With Viral Breakthrough | Participants with confirmed >1.0 log10 increase in HCV RNA from nadir or confirmed HCV RNA >100 IU/mL in participants who had previously achieved HCV RNA \ | Up to follow-up Week 24 |
| Percentage of Participants With Viral Relapse | Participants were considered to have viral relapse if they did not achieve SVR12 and meet the following conditions: 1) at EOT, HCV RNA less than (<)LLOQ, undetectable, and 2) during the follow-up period, HCV RNA greater than or equal to (>=)LLOQ. | Up to follow-up week 24 |
| Barcelona |
| Spain |
| Madrid | Spain |
| Santander | Spain |
| Seville | Spain |
| Valencia | Spain |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | SMV+SOF 12 Weeks | Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12. |
| 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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| 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) | SVR12 is defined as the percentage of participants with 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 received at least 1 dose of study medication (SMV and/or SOF). | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after EOT |
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| Secondary | Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Therapy (SVR4) | SVR4 is defined as the percentage of participants with hepatitis C virus ribonucleic acid (HCV RNA) less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable 4 weeks after actual EOT. | ITT population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF). | Posted | Number | 95% Confidence Interval | percentage of participants | 4 weeks after EOT |
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| Secondary | Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Therapy (SVR24) | Participants were considered to have reached SVR24, if at the time point of SVR24 (that is [i.e.], 24 weeks after the end of treatment [EOT]) the following condition has been met: HCV RNA < lower limit of quantification (LLOQ), i.e., 15 IU/mL, detectable or undetectable. | ITT population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF). | Posted | Number | 95% Confidence Interval | percentage of participants | At 24 weeks after EOT |
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| Secondary | Percentage of Participants With On-treatment Virologic Response of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) | Percentage of participants with HCV RNA less than (<) 15 IU/mL undetectable or detectable or detectable /undetectable at specific time points were observed. | ITT population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF). | Posted | Number | percentage of participants | Week 2, 3, 4, 12 and EOT |
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| Secondary | Percentage of Participants With On-Treatment Failure | Participants were considered on-treatment failures if they have at EOT (confirmed) detectable HCV RNA, i.e., <LLOQ detectable or >=LLOQ. | ITT population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF). | Posted | Number | percentage of participants | through 12 weeks (EOT) |
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| Secondary | Percentage of Participants With Viral Breakthrough | Participants with confirmed >1.0 log10 increase in HCV RNA from nadir or confirmed HCV RNA >100 IU/mL in participants who had previously achieved HCV RNA \ | ITT population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF). | Posted | Number | percentage of participants | Up to follow-up Week 24 |
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| Secondary | Percentage of Participants With Viral Relapse | Participants were considered to have viral relapse if they did not achieve SVR12 and meet the following conditions: 1) at EOT, HCV RNA less than (<)LLOQ, undetectable, and 2) during the follow-up period, HCV RNA greater than or equal to (>=)LLOQ. | ITT population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF). | Posted | Number | percentage of participants | Up to follow-up week 24 |
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Up to EOT (Week 12)
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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 | SMV+SOF 12 Weeks | Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12. | 0 | 40 | 17 | 40 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Catarrh | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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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 | |
|---|---|---|---|---|
| Trial Physician | Janssen R&D BE | ClinicalTrialDisclosure@its.jnj.com |
| 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 |
|---|---|
| D000069616 | Simeprevir |
| D000069474 | Sofosbuvir |
| 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 |
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
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