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| ID | Type | Description | Link |
|---|---|---|---|
| TMC435HPC3005 | Other Identifier | Janssen R&D Ireland |
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The purpose of this study is to provide confirmatory efficacy and safety data of TMC435 as part of a treatment regimen including peginterferon-alpha (PegIFNα-2a) and ribavirin (RBV) in patients with genotype 1 Hepatitis C virus (HCV) infection.
This is a multicenter, randomized (study drug is assigned by chance), double-blind (neither sponsor, physician nor patient knows the name of the assigned study drug), Phase III study to compare the efficacy, tolerability and safety of TMC435 (in development for treatment of chronic hepatitis C virus [HCV] infection) versus placebo (a preparation containing no drug used as control) as part of a treatment regimen including peginterferon-alpha (PegIFNα-2a) and ribavirin (RBV) (both current therapies for HCV) in adult treatment-naïve patients (patients who have never taken HCV medications) with genotype 1 Hepatitis C virus (HCV) infection. The study will consist of a screening period with a maximum duration of 6 weeks, a response guided 24- or 48-week (TMC435 treatment groups) or 48-week (control group) treatment period, and a post-therapy follow-up period up to 72 weeks after the start of treatment. Patients will be randomly assigned in a 1:1:1 fashion to receive TMC435 or placebo, stratified by HCV genotype 1 subtype and IL28B genotype within each country. In the first 24 weeks, patients will receive 12 weeks TMC435 100 or 150 mg or placebo once-daily (q.d.) plus PegIFNα-2a plus RBV, after which they will continue with PegIFNα-2a and RBV. Response-guided treatment criteria will be used to determine PegIFNα-2a and RBV total treatment duration of 24 or 48 weeks for patients in the TMC435 treatment groups. In the control group, all patients will be required to complete 48 weeks of treatment with PegIFNα-2a and RBV. In all 3 treatment groups, there will be a post-therapy follow-up period up to 72 weeks after the start of treatment. The total study duration for each patient will be a maximum of 78 weeks (including the 6-week screening period).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMC435 150 mg | Experimental | Patients will receive 12 weeks TMC435 150 mg once daily (q.d.) plus peginterferon-alpha (PegIFNα-2a) and ribavirin (RBV), followed by PegIFNα-2a and RBV alone. Response-guided treatment criteria will be used to determine total treatment duration of 24 or 48 weeks for patients in the TMC435 treatment groups. Patients in the control group will continue to receive treatment with PegIFNα-2a and RBV until Week 48. |
|
| TMC435 100 mg | Experimental | Patients will receive 12 weeks TMC435 100 mg once daily (q.d.) plus peginterferon-alpha (PegIFNα-2a) and ribavirin (RBV), followed by PegIFNα-2a and RBV alone. Response-guided treatment criteria will be used to determine total treatment duration of 24 or 48 weeks for patients in the TMC435 treatment groups. Patients in the control group will continue PegIFNα-2a and RBV until Week 48. |
|
| Control | Placebo Comparator | Patients will receive placebo once daily (q.d.) plus peginterferon-alpha (PegIFNα-2a) and ribavirin (RBV) for 48 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMC435 | Drug | TMC435 100 mg or 150 mg capsules taken orally (by mouth) with food once-daily for 12 weeks (Week 12). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Study Drug Treatment (SVR12) | Participants considered to have achieved SVR12 if both conditions are met: 1). the hepatitis C virus ribonucleic acid (HCV RNA) is less than (<) lower limit of quantification (LLOQ; 25 international unit per milliliter [IU/mL]) undetectable at end of treatment and, 2). the HCV RNA is < LLOQ detectable or undetectable at 12 weeks after the planned end of study drug treatment. | 12 weeks after the end of treatment (EOT: Week 24 or 48) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Study Drug Treatment (SVR24) | Participants considered to have achieved SVR24 if both conditions are met: 1). the hepatitis C virus ribonucleic acid (HCV RNA) is less than (<) lower limit of quantification (LLOQ;25 IU/mL) undetectable at end of treatment and, 2). the HCV RNA is < LLOQ detectable or undetectable at 24 weeks after the planned end of study drug treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen R&D Ireland Clinical Trial | Janssen R&D Ireland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | China | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks. |
| FG001 | Simeprevir (TMC435) 100mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Peginterferon-alpha (PegIFNα-2a) | Drug | PegIFNα-2a (180 micrograms [μg] once weekly) administered as weekly subcutaneous (s.c.) (under the skin) injections of 0.5 mL for 24 or 48 weeks. |
|
| Ribavirin (RBV) | Drug | Ribavirin 1000 or 1200 mg/day (taken as 100 mg or 200 mg tablets) depending on body weight (If body weight is < 75 kg the total daily dose of RBV will be 1000 mg, administered as 400 mg intake with food in the morning and 600 mg intake with food in the evening. If body weight is > or = 75 kg the total daily dose will be 1200 mg, administered as 2 x 600 mg per intake with food, morning and evening) for 24 or 48 weeks. |
|
| Placebo | Drug | Matching placebo capsules taken orally with food once-daily for 48 weeks. |
|
| 24 weeks after the end of treatment (EOT: Week 24 or 48) |
| Percentage of Participants With Sustained Virologic Response at Week 72 (SVRW72) | Week 72 |
| Percentage of Participants With On-treatment Failure | A participant with on-treatment failure refers to a participant with confirmed detectable HCV RNA at the end of treatment. | End of Treatment (EOT: Week 24 or 48) |
| Percentage of Participants With Viral Breakthrough | The number of patients who experience viral breakthrough will be determined by measuring Hepatitis C virus (HCV) ribonucleic acid (RNA) levels in plasma. Viral breakthrough was defined as a confirmed increase of >1 log10 IU/mL in HCV RNA level from the lowest level reached, or a confirmed HCV RNA level of >100 IU/mL in subjects whose HCV RNA levels had previously been below the limit of quantification (<25 IU/mL detectable) or undetectable (<25 IU/mL undetectable) while on study treatment. | Week 24 or 48 (End of Treatment) |
| Percentage of Participants With Viral Relapse | Viral relapse was defined as undetectable HCV RNA at the actual end of treatment and last HCV RNA measurement during follow-up ≥25 IU/mL. | 72 weeks after the EOT (Week 24 or 48) |
| Percentage of Participants With On-treatment Normalization of Alanine Aminotransferase Level | Percentage of participants with on-treatment normalization of alanine aminotransferase level were assessed. | 72 weeks after the EOT (Week 24 or 48) |
| Changchun |
| China |
| Changsha | China |
| Chengdu | China |
| Chongqing | China |
| Guangzhou | China |
| Hangzhou | China |
| Harbin | China |
| Jinan | China |
| Lanzhou | China |
| Nanjing | China |
| Shanghai | China |
| Shenyang | China |
| Tianjin | China |
| Wuhan | China |
| Zhengzhou | China |
| Busan | South Korea |
| Chuncheon, Gangwon-Do | South Korea |
| Gyeongsangnam-Do | South Korea |
| Incheon | South Korea |
| Seoul | South Korea |
Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
| FG002 | Simeprevir (TMC435) 150mg | Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks. |
| BG001 | Simeprevir (TMC435) 100mg | Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups. |
| BG002 | Simeprevir (TMC435) 150mg | Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 Study Drug Treatment (SVR12) | Participants considered to have achieved SVR12 if both conditions are met: 1). the hepatitis C virus ribonucleic acid (HCV RNA) is less than (<) lower limit of quantification (LLOQ; 25 international unit per milliliter [IU/mL]) undetectable at end of treatment and, 2). the HCV RNA is < LLOQ detectable or undetectable at 12 weeks after the planned end of study drug treatment. | Intent-to-treat (ITT) population included all the randomized participants who took at least 1 dose of study drug. | Posted | Number | Percentage of participants | 12 weeks after the end of treatment (EOT: Week 24 or 48) |
|
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| ||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Study Drug Treatment (SVR24) | Participants considered to have achieved SVR24 if both conditions are met: 1). the hepatitis C virus ribonucleic acid (HCV RNA) is less than (<) lower limit of quantification (LLOQ;25 IU/mL) undetectable at end of treatment and, 2). the HCV RNA is < LLOQ detectable or undetectable at 24 weeks after the planned end of study drug treatment. | ITT population included all the randomized participants who took at least 1 dose of study drug. | Posted | Number | percentage of participants | 24 weeks after the end of treatment (EOT: Week 24 or 48) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Sustained Virologic Response at Week 72 (SVRW72) | ITT population included all the randomized participants who took at least 1 dose of study drug. 'N' (number of participants analyzed) signifies those participants who were analyzed for this measure. | Posted | Number | percentage of participants | Week 72 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With On-treatment Failure | A participant with on-treatment failure refers to a participant with confirmed detectable HCV RNA at the end of treatment. | ITT population included all the randomized participants who took at least 1 dose of study drug. | Posted | Number | percentage of participants | End of Treatment (EOT: Week 24 or 48) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Viral Breakthrough | The number of patients who experience viral breakthrough will be determined by measuring Hepatitis C virus (HCV) ribonucleic acid (RNA) levels in plasma. Viral breakthrough was defined as a confirmed increase of >1 log10 IU/mL in HCV RNA level from the lowest level reached, or a confirmed HCV RNA level of >100 IU/mL in subjects whose HCV RNA levels had previously been below the limit of quantification (<25 IU/mL detectable) or undetectable (<25 IU/mL undetectable) while on study treatment. | ITT population included all the randomized participants who took at least 1 dose of study drug. 'N' (number of participants analyzed) signifies those participants who were analyzed for this measure. | Posted | Number | percentage of participants | Week 24 or 48 (End of Treatment) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Viral Relapse | Viral relapse was defined as undetectable HCV RNA at the actual end of treatment and last HCV RNA measurement during follow-up ≥25 IU/mL. | ITT population included all the randomized participants who took at least 1 dose of study drug. 'N' (number of participants analyzed) signifies those participants who were analyzed for this measure. | Posted | Number | percentage of participants | 72 weeks after the EOT (Week 24 or 48) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With On-treatment Normalization of Alanine Aminotransferase Level | Percentage of participants with on-treatment normalization of alanine aminotransferase level were assessed. | ITT population included all the randomized participants who took at least 1 dose of study drug. 'N' (number of participants analyzed) signifies those participants who were analyzed for this measure. | Posted | Number | percentage of participants | 72 weeks after the EOT (Week 24 or 48) |
|
up to 4 weeks after End of treatment (EOT: Week 24 or Week 48)
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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 | Placebo | Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks. | 9 | 152 | 149 | 152 | ||
| EG001 | Simeprevir (TMC435) 100mg | Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups. | 5 | 153 | 149 | 153 | ||
| EG002 | Simeprevir (TMC435) 150mg | Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups. | 5 | 152 | 149 | 152 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Traumatic lung injury | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Cholesterosis | Metabolism and nutrition disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Ureteric stenosis | Renal and urinary disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Incision site infection | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Chronic hepatitis C | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Undifferentiated connective tissue disease | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutrophil count decreased | Investigations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Red blood cell count decreased | Investigations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Haematocrit decreased | Investigations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Blood bilirubin unconjugated increased | Investigations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Monocyte count decreased | Investigations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Neutrophil percentage decreased | Investigations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Low density lipoprotein decreased | Investigations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Mean cell haemoglobin concentration decreased | Investigations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Mean cell volume increased | Investigations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Blood cholesterol decreased | Investigations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
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 | |
|---|---|---|---|---|
| ASSOCIATE DIRECTOR, MEDICAL DEPARTMENT | Janssen R&D US | 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069616 | Simeprevir |
| 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 |
|
Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups. |
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| OG002 | Simeprevir (TMC435) 150mg | Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups. |
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