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| ID | Type | Description | Link |
|---|---|---|---|
| TMC435HPC3004 | Other Identifier | Janssen Pharmaceutical K.K., Japan |
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The purpose of this study is to evaluate the efficacy and safety of TMC435 in combination with peginterferon alfa-2a (PegIFNα-2a) and ribavirin in genotype 1 hepatitis C virus (HCV)-infected participants who failed to respond to previous interferon (IFN)-based therapy in Japan.
This is a randomized (study drug assigned by chance), 2-arm, open-label study to evaluate the efficacy and safety of TMC435 (also referred to as jnj-38733214-aaa) in combination with the standard of care (SoC) therapy consisting of peginterferon alfa-2a (PegIFNα-2a ) and ribavirin (RBV) administered according to the manufacturer's prescribing information in adult, genotype 1 hepatitis C virus (HCV)-infected participants who failed to respond to previous interferon (IFN)-based therapy in Japan. The study objective is to evaluate the efficacy of TMC435 by the proportion of participants with undetectable HCV ribonucleic acid (RNA). Participants will receive 12 weeks of treatment with TMC435 (100 mg) once daily plus PegIFNα-2a (P) and RBV P) followed by 12 or 36 weeks of treatment with PR OR participants will receive 24 weeks of treatment with TMC435 (100 mg) once daily plus PR followed by 24 weeks of treatment with PR. TMC435 is a 100-mg capsule and will be taken orally (via the mouth). Treatment with PR will last 24 or 48 weeks: Pegylated interferon is supplied as a vial containing 1.0 mL solution with 180 mcg PegIFNα-2a and will be injected by a syringe under the skin once weekly. Ribavirin is given as 200-mg tablets (daily dose: 600-1000 mg based on body weight), and taken orally by mouth two times a day after meals. Participants will receive oral capsules of TMC435 (100 mg) once daily up to Week 12 or 24.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMC435 100 mg 12 Wks + PR24/48 | Experimental | Participants will receive TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment will be stopped at Week 24 if participants achieve plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels < 1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants will continue PR until Week 48. |
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| TMC435 100 mg 24 Wks + PR24/48 | Experimental | Participants will receive TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment will be stopped at Week 24 if participants achieve plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels < 1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants will continue PR until Week 48. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMC435 | Drug | 100-mg capsule taken by mouth once daily for 12 or 24 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Participants With a Sustained Virologic Response at the End of Treatment (EOT) and 12 Weeks After the Last Dose of Treatment (SVR12) | The table below shows the observed percentage of participants in each treatment group with a SVR12 defined as undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels at the EOT (Week 24 or 48) and at 12 weeks after the last dose of treatment (Week 36 or 60). | EOT (Week 24 or 48) and Week 36 or 60 |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Participants With a Sustained Virologic Response 24 Weeks After the End of Treatment (EOT) and 24 Weeks After the Last Dose of Treatment (SVR24) | The table below shows the observed percentage of participants in each treatment group with a SVR24 defined as undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels at the EOT (Week 24 or 48) and at 24 weeks after the last dose of treatment (Week 48 or 72). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K. Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amagasaki | Japan | |||||
Participants with genotype 1 HCV-infection who failed a previous course of interferon (IFN) based therapy received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) until Week 12 (OR Week 24), followed by PR until Week 24/48 based on response-guided treatment (RGT).
The study was conducted between 05-Jan-2011 to 05-Sep-2012 and recruited participants with chronic Hepatitis C Virus (HCV) infection from 23 study centers in Japan. A total of 108 participants were randomized, 106 started treatment, and 101 completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | TMC435 100 mg 12 Wks + PR 24/48 | Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable HCV RNA at Week 12. All other participants continued PR until Week 48. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Peginterferon alfa-2a (PegIFNα-2a ) | Drug | PegIFNα-2a (PEGASYS) will be administered according to the manufacturer's prescribing information as 180 mcg once weekly injected subcutaneous (under the skin) for up to 24-48 weeks. |
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| Ribavirin (RBV) | Drug | RBV (COPEGUS) will be administered according to the manufacturer's prescribing information. If body weight is > 80 kg the total daily dose of RBV will be 1000 mg, taken by mouth as 400 mg (2 tablets of 200 mg) after breakfast and 600 mg (3 tablets of 200 mg) after supper. If body weight is > 60 kg to <=80 kg the total daily dose will be 800 mg, taken by mouth as 400 mg (2 tablets of 200 mg per intake) after breakfast and supper. If body weight is <=60 kg the total daily dose of RBV will be 600 mg, taken by mouth as 200 mg (1 tablet of 200 mg) after breakfast and 400 mg (2 tablets of 200 mg) after supper. Total duration of RBV will be 24-48 weeks. |
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| EOT (Week 24 or 48) and Week 48 or 72 |
| The Percentage of Participants Who Achieved a Greater Than or Equal to 2 log10 IU/mL Drop From Baseline in Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at Each Time Point During Treatment and Follow-up | The table below shows the percentage of participants in each treatment group with a greater than (>) or equal to (=) 2 log10 IU/mL drop from baseline in HCV RNA at each time point during treatment and post-treatment follow-up. | Day 3, Day 7, and Weeks 2, 3, 4, 8, 12, 16, 20, 24, 28, 36, 48, 60, 72, EOT, and Follow-up (FU) Weeks 4, 12, and 24 |
| The Percentage of Participants With Undetectable Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) During Treatment and at the End of Treatment (EOT) | The table below shows the percentage of participants with undetectable HCV RNA (<1.2 log10 IU/mL) during treatment at Weeks 4, 12, 24, 36, 48, 60, 72, and at EOT (Week 24 or 48). | Weeks 4, 12, 24, 36, 48, 60, 72, and at EOT |
| The Percentage of Participants With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels During Treatment for Participants Who Did Not Achieve Undetectable Plasma HCV RNA Levels at Week 12 | The table below shows the percentage of participants with undetectable HCV RNA at Weeks 24, 48, end of treatment (EOT), at the time of assessment for a sustained virologic response (SVR) 12 weeks after the last planned dose (SVR12) (Week 36 or 60), and SVR24 (Week 48 or 72) who did not achieve undetectable HCV RNA levels at Week 12. The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x) if different from the "Number of Participants Analyzed." Results are not available for Weeks 24, 48, and EOT because there were no participants who met the criteria for a SVR at those time points. | Weeks 24, 48, EOT (Weeks 24 or 48), SVR12 (Weeks 36 or 60), and SVR24 (Weeks 48 or 72) |
| The Number of Participants With Viral Breakthrough During the Study | The table below shows the number of all participants in each treatment group who experienced viral breakthrough during the treatment period in the study (Baseline to end of treatment [EOT], ie, Week 24 or 48). Viral breakthrough is defined as a confirmed increase of greater than (>) 1 log10 IU/mL in plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached or a confirmed value of plasma HCV RNA of > 2.0 log10 IU/mL in all participants whose plasma HCV RNA level had previously been below 1.2 log10 IU/mL detectable or undetectable. | Up to EOT (Week 24 or 48) |
| The Number of Participants Demonstrating Viral Relapse During the Study | The table below shows the number of participants in each treatment group who demonstrated viral relapse during the study. Viral relapse is defined as undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels at EOT and detectable HCV RNA during follow-up or detectable HCV RNA at the time points for a sustained viral response (SVR) assessment. The incidence of viral relapse was only calculated for participants with undetectable HCV RNA levels at EOT and with at least one follow-up HCV RNA measurement. | Up to 72 weeks |
| The Number Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal ALT Levels at the End of Treatment (EOT) | The table below shows the number of participants in each treatment group with abnormal ALT levels at baseline (Day 1) who achieved normalization of ALT levels defined as having an ALT value less than or equal to the Upper Limit of Normality (ie, 40 IU/mL) at the EOT. At Baseline, 34/53 participants in the TMC435 100 mg 12 Wks PR 24/48 treatment group and 35/53 participants in the TMC435 100 mg 24 Wks PR 24/48 treatment group had abnormal ALT levels. | EOT (Week 24 or 48) |
| The Percentage of Participants Who Met Response Guided Treatment (RGT) Criteria and Completed Treatment With Peginterferon Alpha-2a (PegIFNα-2a) and Ribavirin (RBV) at Week 24 | The table below shows the percentage of participants in each treatment group who met RGT criteria (ie, who had plasma levels of hepatitis C virus ribonucleic acid [HCV RNA] <1.2 log10 IU/mL detectable/undetectable at Week 4 and <1.2 log 10 IU/mL undetectable at Week 12) and completed treatment with PegIFNα-2a and RBV at Week 24. Participants in the TMC435 treatment groups not meeting RGT criteria continued treatment with PegIFNα-2a and RBV to Week 48. | Week 24 |
| Plasma Concentrations of TMC435 | The table below shows median (range) TMC435 predose plasma concentration (C0h) values and TMC435 maximum plasma concentration (Cmax) values for participants in each treatment group at Week 12, Week 24, and Overall (Weeks 4, 12, and 24). The time frame of "Overall" representes the median exposure estimate using all available data collected at Weeks 4, 12, and 24 for each participant in the study. The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x) if different from the "Number of Participants Analyzed." | Week 12, Week 24, and Overall (Weeks 4, 12, and 24) |
| Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC435 | The table below shows the median (range) AUC24h values for participants in each treatment group at Week 12, Week 24, and Overall (Weeks 4, 12, and 24). The time frame of "Overall" represents the median exposure estimate using all available data collected at Weeks 4, 12, and 24 for each participant in the study. The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x) if different from the "Number of Participants Analyzed." | Week 12, Week 24, and Overall (Weeks 4, 12, and 24) |
| Ichikawa |
| Japan |
| Kagoshima | Japan |
| Kanazawa | Japan |
| Kawasaki | Japan |
| Kitakyushu | Japan |
| Kumamoto | Japan |
| Kurume | Japan |
| Kyoto | Japan |
| Matsumoto | Japan |
| Musashino | Japan |
| Nishinomiya | Japan |
| Osaka | Japan |
| Ōsaka-sayama | Japan |
| Sakai | Japan |
| Sapporo | Japan |
| Suita | Japan |
| Tokyo | Japan |
| Yokohama | Japan |
| FG001 | TMC435 100 mg 24 Wks + PR 24/48 | Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable HCV RNA at Week 12. All other participants continued PR until Week 48. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | TMC435 100 mg 12 Wks + PR 24/48 | Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable HCV RNA at Week 12. All other participants continued PR until Week 48. |
| BG001 | TMC435 100 mg 24 Wks + PR 24/48 | Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable HCV RNA at Week 12. All other participants continued PR until Week 48. |
| 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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| 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 | The Percentage of Participants With a Sustained Virologic Response at the End of Treatment (EOT) and 12 Weeks After the Last Dose of Treatment (SVR12) | The table below shows the observed percentage of participants in each treatment group with a SVR12 defined as undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels at the EOT (Week 24 or 48) and at 12 weeks after the last dose of treatment (Week 36 or 60). | The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication. | Posted | Number | Percentage of participants | EOT (Week 24 or 48) and Week 36 or 60 |
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| Secondary | The Percentage of Participants With a Sustained Virologic Response 24 Weeks After the End of Treatment (EOT) and 24 Weeks After the Last Dose of Treatment (SVR24) | The table below shows the observed percentage of participants in each treatment group with a SVR24 defined as undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels at the EOT (Week 24 or 48) and at 24 weeks after the last dose of treatment (Week 48 or 72). | The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication. | Posted | Number | Percentage of participants | EOT (Week 24 or 48) and Week 48 or 72 |
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| Secondary | The Percentage of Participants Who Achieved a Greater Than or Equal to 2 log10 IU/mL Drop From Baseline in Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at Each Time Point During Treatment and Follow-up | The table below shows the percentage of participants in each treatment group with a greater than (>) or equal to (=) 2 log10 IU/mL drop from baseline in HCV RNA at each time point during treatment and post-treatment follow-up. | The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication. | Posted | Number | Percentage of participants | Day 3, Day 7, and Weeks 2, 3, 4, 8, 12, 16, 20, 24, 28, 36, 48, 60, 72, EOT, and Follow-up (FU) Weeks 4, 12, and 24 |
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| Secondary | The Percentage of Participants With Undetectable Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) During Treatment and at the End of Treatment (EOT) | The table below shows the percentage of participants with undetectable HCV RNA (<1.2 log10 IU/mL) during treatment at Weeks 4, 12, 24, 36, 48, 60, 72, and at EOT (Week 24 or 48). | The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication. | Posted | Number | Percentage of participants | Weeks 4, 12, 24, 36, 48, 60, 72, and at EOT |
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| Secondary | The Percentage of Participants With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels During Treatment for Participants Who Did Not Achieve Undetectable Plasma HCV RNA Levels at Week 12 | The table below shows the percentage of participants with undetectable HCV RNA at Weeks 24, 48, end of treatment (EOT), at the time of assessment for a sustained virologic response (SVR) 12 weeks after the last planned dose (SVR12) (Week 36 or 60), and SVR24 (Week 48 or 72) who did not achieve undetectable HCV RNA levels at Week 12. The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x) if different from the "Number of Participants Analyzed." Results are not available for Weeks 24, 48, and EOT because there were no participants who met the criteria for a SVR at those time points. | The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication. | Posted | Number | Percentage of participants | Weeks 24, 48, EOT (Weeks 24 or 48), SVR12 (Weeks 36 or 60), and SVR24 (Weeks 48 or 72) |
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| Secondary | The Number of Participants With Viral Breakthrough During the Study | The table below shows the number of all participants in each treatment group who experienced viral breakthrough during the treatment period in the study (Baseline to end of treatment [EOT], ie, Week 24 or 48). Viral breakthrough is defined as a confirmed increase of greater than (>) 1 log10 IU/mL in plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached or a confirmed value of plasma HCV RNA of > 2.0 log10 IU/mL in all participants whose plasma HCV RNA level had previously been below 1.2 log10 IU/mL detectable or undetectable. | The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication. | Posted | Number | Participants | Up to EOT (Week 24 or 48) |
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| Secondary | The Number of Participants Demonstrating Viral Relapse During the Study | The table below shows the number of participants in each treatment group who demonstrated viral relapse during the study. Viral relapse is defined as undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels at EOT and detectable HCV RNA during follow-up or detectable HCV RNA at the time points for a sustained viral response (SVR) assessment. The incidence of viral relapse was only calculated for participants with undetectable HCV RNA levels at EOT and with at least one follow-up HCV RNA measurement. | The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication. | Posted | Number | Participants | Up to 72 weeks |
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| Secondary | The Number Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal ALT Levels at the End of Treatment (EOT) | The table below shows the number of participants in each treatment group with abnormal ALT levels at baseline (Day 1) who achieved normalization of ALT levels defined as having an ALT value less than or equal to the Upper Limit of Normality (ie, 40 IU/mL) at the EOT. At Baseline, 34/53 participants in the TMC435 100 mg 12 Wks PR 24/48 treatment group and 35/53 participants in the TMC435 100 mg 24 Wks PR 24/48 treatment group had abnormal ALT levels. | The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication. | Posted | Number | Participants | EOT (Week 24 or 48) |
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| Secondary | The Percentage of Participants Who Met Response Guided Treatment (RGT) Criteria and Completed Treatment With Peginterferon Alpha-2a (PegIFNα-2a) and Ribavirin (RBV) at Week 24 | The table below shows the percentage of participants in each treatment group who met RGT criteria (ie, who had plasma levels of hepatitis C virus ribonucleic acid [HCV RNA] <1.2 log10 IU/mL detectable/undetectable at Week 4 and <1.2 log 10 IU/mL undetectable at Week 12) and completed treatment with PegIFNα-2a and RBV at Week 24. Participants in the TMC435 treatment groups not meeting RGT criteria continued treatment with PegIFNα-2a and RBV to Week 48. | The Full Analysis Set (FAS) consisted of all randomized participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication. | Posted | Number | Percentage of participants | Week 24 |
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| Secondary | Plasma Concentrations of TMC435 | The table below shows median (range) TMC435 predose plasma concentration (C0h) values and TMC435 maximum plasma concentration (Cmax) values for participants in each treatment group at Week 12, Week 24, and Overall (Weeks 4, 12, and 24). The time frame of "Overall" representes the median exposure estimate using all available data collected at Weeks 4, 12, and 24 for each participant in the study. The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x) if different from the "Number of Participants Analyzed." | Pharmacokinetic analysis was performed in the pharmacokinetic (PK) population, defined as all participants from whom sparse blood samples were drawn and who received at least 1 dose of study medication. | Posted | Median | Full Range | ng/mL | Week 12, Week 24, and Overall (Weeks 4, 12, and 24) |
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| Secondary | Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC435 | The table below shows the median (range) AUC24h values for participants in each treatment group at Week 12, Week 24, and Overall (Weeks 4, 12, and 24). The time frame of "Overall" represents the median exposure estimate using all available data collected at Weeks 4, 12, and 24 for each participant in the study. The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x) if different from the "Number of Participants Analyzed." | Pharmacokinetic analysis was performed in the pharmacokinetic (PK) population, defined as all participants from whom sparse blood samples were drawn and who received at least 1 dose of study medication. | Posted | Median | Full Range | ng.h/mL | Week 12, Week 24, and Overall (Weeks 4, 12, and 24) |
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Up to approximately 52 weeks (includes all serious and other adverse events that newly occurred or worsened after treatment with TMC435, PegIFNα-2b or ribavirin, until the end date of the last study medication intake + 28 days).
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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 | TMC435 100 mg 12 Wks + PR 24/48 | Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable HCV RNA at Week 12. All other participants continued PR until Week 48. | 2 | 53 | 53 | 53 | ||
| EG001 | TMC435 100 mg 24 Wks + PR 24/48 | Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable HCV RNA at Week 12. All other participants continued PR until Week 48. | 3 | 53 | 52 | 53 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Laceration | Injury, poisoning and procedural complications | MedDRA Version 15.0 | Non-systematic Assessment |
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| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Pyelonephritis acute | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Calculus ureteric | Renal and urinary disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Malaise | General disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Injection site reaction | General disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Injection site erythema | General disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA Version 15.0 | Non-systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA Version 15.0 | Non-systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA Version 15.0 | Non-systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA Version 15.0 | Non-systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA Version 15.0 | Non-systematic Assessment |
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| Haematocrit decreased | Investigations | MedDRA Version 15.0 | Non-systematic Assessment |
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| Red blood cell count decreased | Investigations | MedDRA Version 15.0 | Non-systematic Assessment |
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| Blood cholesterol decreased | Investigations | MedDRA Version 15.0 | Non-systematic Assessment |
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| Blood triglycerides increased | Investigations | MedDRA Version 15.0 | Non-systematic Assessment |
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| High density lipoprotein decreased | Investigations | MedDRA Version 15.0 | Non-systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA Version 15.0 | Non-systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA Version 15.0 | Non-systematic Assessment |
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| Blood calcium decreased | Investigations | MedDRA Version 15.0 | Non-systematic Assessment |
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| Blood thyroid stimulating hormone increased | Investigations | MedDRA Version 15.0 | Non-systematic Assessment |
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| Bilirubin conjugated increased | Investigations | MedDRA Version 15.0 | Non-systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA Version 15.0 | Non-systematic Assessment |
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| Lipase increased | Investigations | MedDRA Version 15.0 | Non-systematic Assessment |
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| Low density lipoprotein decreased | Investigations | MedDRA Version 15.0 | Non-systematic Assessment |
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| Weight decreased | Investigations | MedDRA Version 15.0 | Non-systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Dental caries | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Cheilitis | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Retinopathy | Eye disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Dry eye | Eye disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA Version 15.0 | Non-systematic Assessment |
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| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA Version 15.0 | 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 to allow for filing of a patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager | Janssen Pharmaceutical K.K., Japan | 81 3 44115639 |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069616 | Simeprevir |
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| 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 |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Male |
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| OG001 | TMC435 100 mg 24 Wks + PR24/48 | Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48. |
|
|
Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
|
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Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
|
|
Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
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