- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT01579474
Japanese Pegylated Interferon (PegIFN) Alfa-2b/Ribavirin (RBV) Combination Trial
Safety, Efficacy and Pharmacokinetics of BI 201335 NA in Patient With Genotype 1 Chronic Hepatitis C Virus Infection in Combination With Pegylated Interferon Alfa-2b and Ribavirin - Cohort 1 for Treatment-naive Patients: Randomised, Double-blind Part of BI 201335 NA for 12 or 24 Weeks - Cohort 2 for Treatment-experienced Patients: Open-label Part of BI 201335 NA for 24 Weeks
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 3
Контакты и местонахождение
Места учебы
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Chuo-ku, Chiba, Япония
- 1220.54.08104 Boehringer Ingelheim Investigational Site
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Chuo-ku, Kobe, Hyogo, Япония
- 1220.54.08118 Boehringer Ingelheim Investigational Site
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Fukui, Fukui, Япония
- 1220.54.08108 Boehringer Ingelheim Investigational Site
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Gifu, Gifu, Япония
- 1220.54.08110 Boehringer Ingelheim Investigational Site
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Itabashi-ku, Tokyo, Япония
- 1220.54.08105 Boehringer Ingelheim Investigational Site
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Izunokuni, Shizuoka, Япония
- 1220.54.08112 Boehringer Ingelheim Investigational Site
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Kanazawa, Ishikawa, Япония
- 1220.54.08107 Boehringer Ingelheim Investigational Site
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Kita-gun, Kagawa, Япония
- 1220.54.08120 Boehringer Ingelheim Investigational Site
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Kofu, Yamanashi, Япония
- 1220.54.08109 Boehringer Ingelheim Investigational Site
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Kurume, Fukuoka, Япония
- 1220.54.08123 Boehringer Ingelheim Investigational Site
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Mtsuyama, Ehime, Япония
- 1220.54.08121 Boehringer Ingelheim Investigational Site
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Nagoya, Aichi, Япония
- 1220.54.08113 Boehringer Ingelheim Investigational Site
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Nishinomiya, Hyogo, Япония
- 1220.54.08117 Boehringer Ingelheim Investigational Site
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Ogaki, Gifu, Япония
- 1220.54.08111 Boehringer Ingelheim Investigational Site
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Oo mura, Nagasaki,, Япония
- 1220.54.08124 Boehringer Ingelheim Investigational Site
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Osaka, Osaka, Япония
- 1220.54.08115 Boehringer Ingelheim Investigational Site
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Osakasayama, Osaka, Япония
- 1220.54.08116 Boehringer Ingelheim Investigational Site
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Sapporo, Hokkaido, Япония
- 1220.54.08101 Boehringer Ingelheim Investigational Site
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Sendai, Miyagi, Япония
- 1220.54.08102 Boehringer Ingelheim Investigational Site
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Tanabe, Wakayama, Япония
- 1220.54.08119 Boehringer Ingelheim Investigational Site
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Toyama,Toyama, Япония
- 1220.54.08106 Boehringer Ingelheim Investigational Site
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Tsu, Mie, Япония
- 1220.54.08114 Boehringer Ingelheim Investigational Site
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Yahatanishi-ku, Kitakyusyu, Fukuoka, Япония
- 1220.54.08122 Boehringer Ingelheim Investigational Site
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Yamagata, Yamagata, Япония
- 1220.54.08125 Boehringer Ingelheim Investigational Site
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion criteria:
Chronic hepatitis C infection, diagnosed by positive anti-HCV antibodies and detected HCV RNA at screening in addition to:
- positive anti-HCV antibodies or detected HCV RNA at least 6 months before screening; or,
- liver biopsy consistent with chronic HCV infection.
- HCV genotype 1 infection confirmed by genotypic testing at screening
- (For Cohort 1 only) Therapy-naïve to interferon, pegylated interferon, and ribavirin (For Cohort 2 only) Confirmed prior virological failure (null response, partial response, breakthrough or relapse) with an approved dose of PegIFN alfa/RBV or IFN beta/RBV for at least 12 weeks and with an 8-week washout period before screening
- HCV RNA = 100,000 IU/mL at screening
- Documentation of a liver biopsy within 3 years or fibroscan within 6 months before randomization (Visit 2)
- Age 20 to 70 years
Female patients who are infertile or who are of childbearing potential with a negative pregnancy test and agreeing to use one accepted method of birth control in addition to the use of a condom by their male partners.
or Male patients who are infertile, who are without pregnant female partners or who consistently and correctly use condoms.
- Signed informed consent form before trial participation
Exclusion criteria:
- HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening,
- Evidence of acute or chronic liver disease due to causes other than chronic HCV infection. Steatosis diagnosed incidentally (e.g. by biopsy) without clinical relevance is not an exclusion criterion.
- HIV co-infection,
- Hepatitis B virus (HBV) infection based on presence of hepatitis B surface antigen (HBsAg),
- Active malignancy, or history of malignancy within the last 5 years prior to screening (with an exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix),
- Active or, history of alcohol or illicit drug abuse within the past 12 months,
- A condition that is defined as one which in the opinion of investigator may put the patient at risk because of participation in this study, may influence the results of this study, or limit the patient's ability to participate in this study,
- Usage of any investigational drugs within 30 days prior to screening, or planned usage of an investigational drug during the course of this study,
- Received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 30 days prior to screening. Patients being treated with oral antivirals such as acyclovir, famciclovir or valacyclovir for recurrent herpes simplex infection; or with oseltamivir or zanamivir for influenza A infection, may be screened,
- Received silymarin (milk thistle), glycyrrhizin (Stronger Neo-Minophagen C; SNMC), or Sho-saiko-to (SST) within 28 days prior to randomization (Visit 2) and throughout the treatment phase of this trial,
- (For Cohort 2 only) Patients who have been previously treated with at least one dose of any antiviral or immunomodulatory drug other than (pegylated) interferon alfa, interferon beta or ribavirin for acute or chronic HCV infection including and not restricted to protease or polymerase inhibitors,
- Known hypersensitivity to any ingredient of the study drugs,
- Alpha fetoprotein value >100 ng/mL at screening; if >20 ng/mL and =100 ng/mL, patients may be included if there is no evidence of liver cancer in an appropriate imaging study (e.g., ultrasound, CT scan, or MRI) within last 6 months prior to randomization (Visit 2),
Other exclusion criteria related to pegylated interferon and/or ribavirin restrictions are not listed here.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: 1. BI 201335 low dose plus PegIFN/RBV
low dose BI 201335 NA once daily for 12 or 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-naive patients
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BI 201335 low dose with PegIFN/RBV
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Экспериментальный: 2. BI 201335 high dose plus PegIFN/RBV
high dose BI 201335 NA once daily for 12 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-naive patients
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BI 201335 high dose with PegIFN/RBV
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Экспериментальный: 3. BI 201335 high dose plus PegIFN/RBV
high dose BI 201335 NA once daily for 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients
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BI 201335 high dose with PegIFN/RBV
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Экспериментальный: 4. BI 201335 high dose plus PegIFN/RBV
high dose BI 201335 NA once daily for 24 weeks combined with PegIFN/RBV for 48 weeks in treatment-experienced (null responder, partial responder, breakthrough) patients
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BI 201335 high dose with PegIFN/RBV
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Number of Patients With Investigator Defined Drug-related Adverse Events
Временное ограничение: Up to 52 weeks
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Drug-related AEs were defined as those whose causal relationship with any one of the investigational products was considered by the investigator.
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Up to 52 weeks
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Sustained Virological Response (SVR12), Defined as Plasma HCV RNA Undetectable at 12 Weeks After End of Treatment (EOT)
Временное ограничение: EOT (up to Week 24 or 48) and 12 weeks after the EOT (up to Week 36 or 60)
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Plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration
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EOT (up to Week 24 or 48) and 12 weeks after the EOT (up to Week 36 or 60)
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Sustained Virological Response (SVR24), Defined as Plasma HCV RNA Undetectable at 24 Weeks After End of Treatment (EOT)
Временное ограничение: EOT (up to Week 24 or 48) and 24 weeks after the EOT (up to Week 48 or 72)
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Plasma HCV RNA level <25 IU/mL (undetected) 24 weeks after the originally planned treatment duration
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EOT (up to Week 24 or 48) and 24 weeks after the EOT (up to Week 48 or 72)
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Early Treatment Success (ETS), Defined as Plasma HCV RNA <25 IU/mL at Week 4 and HCV RNA Undetectable at Week 8
Временное ограничение: up to 8 weeks
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Plasma HCV RNA level <25 IU/mL (detected or undetected) at Week 4 and HCV RNA <25 IU/mL (undetected) at Week 8
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up to 8 weeks
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Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES
Временное ограничение: EOT (up to Week 24 or 48)
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This will be presented as the number of patients.
SVR12 means Sustained virological response 12 weeks post-treatment.
BL = Baseline
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EOT (up to Week 24 or 48)
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Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO
Временное ограничение: EOT (up to Week 24 or 48)
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This will be presented as the number of patients.
SVR12 means Sustained virological response 12 weeks post-treatment.
BL = Baseline
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EOT (up to Week 24 or 48)
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Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES
Временное ограничение: 12 weeks after the EOT (up to Week 36 or 60)
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This will be presented as the number of patients.
SVR12 means Sustained virological response 12 weeks post-treatment.
BL = Baseline
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12 weeks after the EOT (up to Week 36 or 60)
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Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO
Временное ограничение: 12 weeks after the EOT (up to Week 36 or 60)
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This will be presented as the number of patients.
SVR12 means Sustained virological response 12 weeks post-treatment.
BL = Baseline
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12 weeks after the EOT (up to Week 36 or 60)
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Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES
Временное ограничение: EOT (up to Week 24 or 48)
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This will be presented as the number of patients.
SVR12 means Sustained virological response 12 weeks post-treatment.
BL = Baseline
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EOT (up to Week 24 or 48)
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Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO
Временное ограничение: EOT (up to Week 24 or 48)
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This will be presented as the number of patients.
SVR12 means Sustained virological response 12 weeks post-treatment.
BL = Baseline
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EOT (up to Week 24 or 48)
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Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES
Временное ограничение: 12 weeks after the EOT (up to Week 36 or 60)
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This will be presented as the number of patients.
SVR12 means Sustained virological response 12 weeks post-treatment.
BL = Baseline
|
12 weeks after the EOT (up to Week 36 or 60)
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Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO
Временное ограничение: 12 weeks after the EOT (up to Week 36 or 60)
|
This will be presented as the number of patients.
SVR12 means Sustained virological response 12 weeks post-treatment.
BL = Baseline
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12 weeks after the EOT (up to Week 36 or 60)
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Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 1220.54
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования Гепатит С
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Meir Medical CenterЗавершенныйРазработка новой методики измерения отношения C/D по изображениям цифровых стереооптических дисков | Воспроизводимость измерений C/D внутри наблюдателя | Межнаблюдательная изменчивость измерений C/D
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University Hospital, GrenobleClinical Investigation Centre for Innovative Technology NetworkЗавершенныйC. Хирургическая процедураФранция
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Cairo UniversityЗавершенныйОсложнения; C, кишечный (внутренний)Египет
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Erasme University HospitalJean Paul Van VoorenНеизвестный
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Fudan UniversityНеизвестныйC. Доставка; Хирургия (Предыдущая), Гинекология
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Fudan UniversityЗавершенныйC. Доставка; Хирургия (Предыдущая), Гинекология
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Fudan UniversityНеизвестныйC. Доставка; Хирургия (Предыдущая), Гинекология
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Cairo UniversityНеизвестныйC-образный корневой каналЕгипет
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University Hospital, Basel, SwitzerlandЗавершенныйКалечащие операции на женских половых органах / Обрезание (FGM/C)Швейцария
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Brigham and Women's HospitalCenters for Disease Control and Prevention; Harvard Pilgrim Health Care Institute; Massachusetts... и другие соавторыРекрутингC. ТрудныйСоединенные Штаты
Клинические исследования BI 201335 low dose
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Boehringer IngelheimЗавершенный
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Boehringer IngelheimЗавершенный
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Boehringer IngelheimЗавершенныйГепатит С, хроническийСоединенные Штаты, Аргентина, Австралия, Австрия, Канада, Чешская Республика, Франция, Германия, Корея, Республика, Нидерланды, Португалия, Румыния, Испания, Швейцария, Соединенное Королевство
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Boehringer IngelheimЗавершенный
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Boehringer IngelheimЗавершенный
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Boehringer IngelheimЗавершенныйГепатит С, хроническийСоединенные Штаты, Австрия, Канада, Франция, Германия, Венгрия, Ирландия, Италия, Нидерланды, Португалия, Румыния, Российская Федерация, Испания, Соединенное Королевство
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Boehringer IngelheimЗавершенный
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Boehringer IngelheimПрекращено