Safety, Antiviral Effect and PK of BI 207127 + BI 201335 +/- RBV for 4 up to 40 Weeks in Patients With Chronic HCV Genotype 1 Infection
22 декабря 2015 г. обновлено: Boehringer Ingelheim
Safety, Antiviral Effect and Pharmacokinetics of BI 207127 in Combination With BI 201335 and With or Without Ribavirin for 4, 16, 24, 28 or 40 Weeks in Patients With Chronic HCV Genotype 1 Infection (Randomized Phase Ib/II)
The substances BI 201335 and BI 207127 are being developed for the treatment of chronic hepatitis C virus infection. BI 201335 and BI 207127 work by preventing the virus from replicating.
The currently available medications pegylated interferon alfa and ribavirin for hepatitis C ca have considerable adverse events in patients and in many cases are not sufficiently effective. This is particularly the case in treatment of patients infected with genotype 1 of HCV.
A combination therapy of these new substances without pegylated interferon alfa may be associated with fewer adverse events that currently available (pegylated interferon-alfa-based) medication and may also provide a treatment option to the large number of patients with contraindications or intolerance to pegylated interferon alfa.
This clinical trial (1241.21) currently consists of 3 distinct studies: Part 1, Part 2 and Part 3.
Part 1 (SOUND-C1) is a 2 armed study as described in experimental arms 1 and 2 below (actual enrollment: 56 patients; randomized and treated: 32) Part 2 (SOUND-C2) is a 5 armed study as described in experimental arms 3 to 7 below (actual enrollment: 465; randomized and treated: 362) Part 3 (SOUND-C3) includes 3 arms as described in experimental arms 8 to 10 below (83 patients randomized and treated)
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
- Лекарство: BI 207127
- Лекарство: BI 201335
- Лекарство: BI 207127
- Лекарство: BI 201335
- Лекарство: Ribavirin
- Лекарство: Ribavirin
- Лекарство: BI 207127
- Лекарство: BI 207127
- Лекарство: BI 207127
- Лекарство: Ribavirin
- Лекарство: Ribavirin
- Лекарство: BI 207127
- Лекарство: BI 201335
- Лекарство: BI 201335
- Лекарство: Ribavirin
- Лекарство: BI 207127
- Лекарство: BI 207127
- Лекарство: BI 207127
- Лекарство: BI 207127
- Лекарство: BI 207217
Тип исследования
Интервенционный
Регистрация (Действительный)
488
Фаза
- Фаза 2
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Victoria
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Heidelberg, Victoria, Австралия
- 1241.21.61002 Boehringer Ingelheim Investigational Site
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Melbourne, Victoria, Австралия
- 1241.21.61001 Boehringer Ingelheim Investigational Site
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Linz, Австрия
- 1241.21.43003 Boehringer Ingelheim Investigational Site
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Wien, Австрия
- 1241.21.43001 Boehringer Ingelheim Investigational Site
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Wien, Австрия
- 1241.21.43002 Boehringer Ingelheim Investigational Site
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Berlin, Германия
- 1241.21.49002 Boehringer Ingelheim Investigational Site
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Berlin, Германия
- 1241.21.49003 Boehringer Ingelheim Investigational Site
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Düsseldorf, Германия
- 1241.21.49007 Boehringer Ingelheim Investigational Site
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Esslingen, Германия
- 1241.21.49005 Boehringer Ingelheim Investigational Site
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Frankfurt am Main, Германия
- 1241.21.49001 Boehringer Ingelheim Investigational Site
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Hamburg, Германия
- 1241.21.49006 Boehringer Ingelheim Investigational Site
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Hannover, Германия
- 1241.21.49009 Boehringer Ingelheim Investigational Site
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Leipzig, Германия
- 1241.21.49004 Boehringer Ingelheim Investigational Site
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Mainz, Германия
- 1241.21.49008 Boehringer Ingelheim Investigational Site
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Barcelona, Испания
- 1241.21.34002 Boehringer Ingelheim Investigational Site
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Barcelona, Испания
- 1241.21.34005 Boehringer Ingelheim Investigational Site
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Madrid, Испания
- 1241.21.34003 Boehringer Ingelheim Investigational Site
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Madrid, Испания
- 1241.21.34004 Boehringer Ingelheim Investigational Site
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Majadahonda-Madrid, Испания
- 1241.21.34001 Boehringer Ingelheim Investigational Site
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Valencia, Испания
- 1241.21.34006 Boehringer Ingelheim Investigational Site
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Auckland NZ, Новая Зеландия
- 1241.21.64001 Boehringer Ingelheim Investigational Site
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Aveiro, Португалия
- 1241.21.35103 Boehringer Ingelheim Investigational Site
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Coimbra, Португалия
- 1241.21.35104 Boehringer Ingelheim Investigational Site
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Lisboa, Португалия
- 1241.21.35101 Boehringer Ingelheim Investigational Site
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Lisboa, Португалия
- 1241.21.35105 Boehringer Ingelheim Investigational Site
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Porto, Португалия
- 1241.21.35102 Boehringer Ingelheim Investigational Site
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Bucharest, Румыния
- 1241.21.40001 Boehringer Ingelheim Investigational Site
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Bucharest, Румыния
- 1241.21.40002 Boehringer Ingelheim Investigational Site
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Bucharest, Румыния
- 1241.21.40003 Boehringer Ingelheim Investigational Site
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California
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La Jolla, California, Соединенные Штаты
- 1241.21.0003 Boehringer Ingelheim Investigational Site
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San Diego, California, Соединенные Штаты
- 1241.21.0006 Boehringer Ingelheim Investigational Site
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San Francisco, California, Соединенные Штаты
- 1241.21.0004 Boehringer Ingelheim Investigational Site
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Florida
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Palm Harbor, Florida, Соединенные Штаты
- 1241.21.0011 Boehringer Ingelheim Investigational Site
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Indiana
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Valparaiso, Indiana, Соединенные Штаты
- 1241.21.0013 Boehringer Ingelheim Investigational Site
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Massachusetts
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Springfield, Massachusetts, Соединенные Штаты
- 1241.21.0008 Boehringer Ingelheim Investigational Site
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North Carolina
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Fayetteville, North Carolina, Соединенные Штаты
- 1241.21.0019 Boehringer Ingelheim Investigational Site
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Texas
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Arlington, Texas, Соединенные Штаты
- 1241.21.0012 Boehringer Ingelheim Investigational Site
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Austin, Texas, Соединенные Штаты
- 1241.21.0005 Boehringer Ingelheim Investigational Site
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Dallas, Texas, Соединенные Штаты
- 1241.21.0007 Boehringer Ingelheim Investigational Site
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Houston, Texas, Соединенные Штаты
- 1241.21.0010 Boehringer Ingelheim Investigational Site
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Washington
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Seattle, Washington, Соединенные Штаты
- 1241.21.0017 Boehringer Ingelheim Investigational Site
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Clichy, Франция
- 1241.21.33005 Boehringer Ingelheim Investigational Site
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Grenoble cédex 9, Франция
- 1241.21.33007 Boehringer Ingelheim Investigational Site
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Lyon, Франция
- 1241.21.33003 Boehringer Ingelheim Investigational Site
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Marseille, Франция
- 1241.21.33001 Boehringer Ingelheim Investigational Site
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Montpellier, Франция
- 1241.21.33002 Boehringer Ingelheim Investigational Site
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Paris, Франция
- 1241.21.33004 Boehringer Ingelheim Investigational Site
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Paris, Франция
- 1241.21.33008 Boehringer Ingelheim Investigational Site
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Vandoeuvre Cedex, Франция
- 1241.21.33006 Boehringer Ingelheim Investigational Site
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Basel, Швейцария
- 1241.21.41003 Boehringer Ingelheim Investigational Site
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Bern, Швейцария
- 1241.21.41006 Boehringer Ingelheim Investigational Site
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St. Gallen, Швейцария
- 1241.21.41001 Boehringer Ingelheim Investigational Site
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Zürich, Швейцария
- 1241.21.41002 Boehringer Ingelheim Investigational Site
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
От 18 лет до 75 лет (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
Inclusion criteria:
- Chronic hepatitis C virus (HCV) infection of genotype (GT) 1
- Parts 1-3:Treatment naive to Interferon -alfa (IFN), Pegylated interferon -alfa (PegIFN), ribavirin (RBV), and any direct acting antiviral agent for chronic hepatitis C
- Part 4: Treatment experienced with confirmed prior virological failure to an approved dose of PegIFN/RBV (null-response)
- HCV RNA >=10,000 IU/mL at screening
- Liver biopsy within two years or fibroscan within six months prior to baseline
- Liver biopsy within two years or fibroscan within 6 months prior to screening
- Age 18-75 years
Exclusion criteria:
- Hepatitis C virus (HCV) infection of mixed genotype
- Evidence of liver disease due to causes other than chronic HCV infection
- Positive ELISA for human immunodeficiency virus (HIV)
- Hepatitis B virus (HBV) infection
- Decompensated liver disease or history of decompensated liver disease
- Active or suspected malignancy within the last 5 years
- Ongoing or historical photosensitivity or recurrent rash
- History of alcohol or drug abuse (except cannabis) within the past 12 months
- Body mass index (BMI)I <18 or > 35 kg/m2
- Usage of any investigational drugs within 30 days prior to enrolment, or 5 half-lives, whichever is longer; o the planned usage of an investigational drug during the course of the current study
- Known hypersensitivity to any ingredient of the study drugs
- A condition that is defined as one which in the opinion of the investigator may interfere with the patient's capability for participation in the trial or may influence the results of the trial
- Alpha fetoprotein >100ng/mL at screening; if >20ng/mL and <=100ng/mL, patients can be included if there is no evidence of liver cancer in an appropriate imaging study within 6 months prior to randomisation
- Total bilirubin > 2 mg/dL with ratio of direct/indirect > 1
- AST or ALT >5xULN
- INR prolonged to >1.7xULN
- Requirement for chronic systemic corticosteroids
- Received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 30 days prior to enrolment or 5 half-lives, whichever is longer
- Received silymarin or glycyrrhizin or Sho-saiko-to within 30 days prior to enrolment
- Contraindications pertaining to PegIFN or RBV
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 2
4 weeks of high dose TID BI 207127 and QD BI 201335 in combination with RBV, Part 1
|
28 weeks, high dose, TID
40 weeks, QD
4 weeks, low dose TID
24 weeks, QD
16 weeks, according to label
28 weeks, according to label
40 weeks, high dose, TID
24 weeks, very high dose, BID
16 weeks, standard dose, BID
48 weeks, according to label
40 weeks, according to label
16 weeks, high dose, TID
28 weeks, QD
16 weeks, QD
24 weeks, according to label
24 weeks, standard dose, BID
16 weeks, high dose, BID
24 weeks, high dose, TID
4 weeks, high dose, TID
|
|
Экспериментальный: 1
4 weeks of low dose three times per day (TID) BI 207127 and once daily (QD) BI 201335 in combination with RBV, Part 1
|
28 weeks, high dose, TID
40 weeks, QD
4 weeks, low dose TID
24 weeks, QD
16 weeks, according to label
28 weeks, according to label
40 weeks, high dose, TID
24 weeks, very high dose, BID
16 weeks, standard dose, BID
48 weeks, according to label
40 weeks, according to label
16 weeks, high dose, TID
28 weeks, QD
16 weeks, QD
24 weeks, according to label
24 weeks, standard dose, BID
16 weeks, high dose, BID
24 weeks, high dose, TID
4 weeks, high dose, TID
|
|
Экспериментальный: 3
16 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2
|
28 weeks, high dose, TID
40 weeks, QD
4 weeks, low dose TID
24 weeks, QD
16 weeks, according to label
28 weeks, according to label
40 weeks, high dose, TID
24 weeks, very high dose, BID
16 weeks, standard dose, BID
48 weeks, according to label
40 weeks, according to label
16 weeks, high dose, TID
28 weeks, QD
16 weeks, QD
24 weeks, according to label
24 weeks, standard dose, BID
16 weeks, high dose, BID
24 weeks, high dose, TID
4 weeks, high dose, TID
|
|
Экспериментальный: 4
28 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2
|
28 weeks, high dose, TID
40 weeks, QD
4 weeks, low dose TID
24 weeks, QD
16 weeks, according to label
28 weeks, according to label
40 weeks, high dose, TID
24 weeks, very high dose, BID
16 weeks, standard dose, BID
48 weeks, according to label
40 weeks, according to label
16 weeks, high dose, TID
28 weeks, QD
16 weeks, QD
24 weeks, according to label
24 weeks, standard dose, BID
16 weeks, high dose, BID
24 weeks, high dose, TID
4 weeks, high dose, TID
|
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Экспериментальный: 5
40 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2
|
28 weeks, high dose, TID
40 weeks, QD
4 weeks, low dose TID
24 weeks, QD
16 weeks, according to label
28 weeks, according to label
40 weeks, high dose, TID
24 weeks, very high dose, BID
16 weeks, standard dose, BID
48 weeks, according to label
40 weeks, according to label
16 weeks, high dose, TID
28 weeks, QD
16 weeks, QD
24 weeks, according to label
24 weeks, standard dose, BID
16 weeks, high dose, BID
24 weeks, high dose, TID
4 weeks, high dose, TID
|
|
Экспериментальный: 6
28 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 2
|
40 weeks, QD
24 weeks, QD
16 weeks, according to label
28 weeks, according to label
48 weeks, according to label
40 weeks, according to label
28 weeks, QD
16 weeks, QD
24 weeks, according to label
28 weeks, high dose BID
|
|
Экспериментальный: 7
28 weeks of TID BI 207127 and QD BI 201335 without RBV, Part 2
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28 weeks, high dose, TID
40 weeks, QD
4 weeks, low dose TID
24 weeks, QD
40 weeks, high dose, TID
24 weeks, very high dose, BID
16 weeks, standard dose, BID
16 weeks, high dose, TID
28 weeks, QD
16 weeks, QD
24 weeks, standard dose, BID
16 weeks, high dose, BID
24 weeks, high dose, TID
4 weeks, high dose, TID
|
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Экспериментальный: 8
16 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 3
|
28 weeks, high dose, TID
40 weeks, QD
4 weeks, low dose TID
24 weeks, QD
16 weeks, according to label
28 weeks, according to label
40 weeks, high dose, TID
24 weeks, very high dose, BID
16 weeks, standard dose, BID
48 weeks, according to label
40 weeks, according to label
16 weeks, high dose, TID
28 weeks, QD
16 weeks, QD
24 weeks, according to label
24 weeks, standard dose, BID
16 weeks, high dose, BID
24 weeks, high dose, TID
4 weeks, high dose, TID
|
|
Экспериментальный: 9
24 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 3
|
28 weeks, high dose, TID
40 weeks, QD
4 weeks, low dose TID
24 weeks, QD
16 weeks, according to label
28 weeks, according to label
40 weeks, high dose, TID
24 weeks, very high dose, BID
16 weeks, standard dose, BID
48 weeks, according to label
40 weeks, according to label
16 weeks, high dose, TID
28 weeks, QD
16 weeks, QD
24 weeks, according to label
24 weeks, standard dose, BID
16 weeks, high dose, BID
24 weeks, high dose, TID
4 weeks, high dose, TID
|
|
Экспериментальный: 10
24 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 3
|
28 weeks, high dose, TID
40 weeks, QD
4 weeks, low dose TID
24 weeks, QD
16 weeks, according to label
28 weeks, according to label
40 weeks, high dose, TID
24 weeks, very high dose, BID
16 weeks, standard dose, BID
48 weeks, according to label
40 weeks, according to label
16 weeks, high dose, TID
28 weeks, QD
16 weeks, QD
24 weeks, according to label
24 weeks, standard dose, BID
16 weeks, high dose, BID
24 weeks, high dose, TID
4 weeks, high dose, TID
|
|
Экспериментальный: 11
16 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 4
|
28 weeks, high dose, TID
40 weeks, QD
4 weeks, low dose TID
24 weeks, QD
16 weeks, according to label
28 weeks, according to label
40 weeks, high dose, TID
24 weeks, very high dose, BID
16 weeks, standard dose, BID
48 weeks, according to label
40 weeks, according to label
16 weeks, high dose, TID
28 weeks, QD
16 weeks, QD
24 weeks, according to label
24 weeks, standard dose, BID
16 weeks, high dose, BID
24 weeks, high dose, TID
4 weeks, high dose, TID
|
|
Экспериментальный: 12
24 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 4
|
28 weeks, high dose, TID
40 weeks, QD
4 weeks, low dose TID
24 weeks, QD
16 weeks, according to label
28 weeks, according to label
40 weeks, high dose, TID
24 weeks, very high dose, BID
16 weeks, standard dose, BID
48 weeks, according to label
40 weeks, according to label
16 weeks, high dose, TID
28 weeks, QD
16 weeks, QD
24 weeks, according to label
24 weeks, standard dose, BID
16 weeks, high dose, BID
24 weeks, high dose, TID
4 weeks, high dose, TID
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Part 1: Rapid Virological Response (RVR)
Временное ограничение: 4 weeks
|
Part 1: Rapid virological response (RVR), defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) <25IU/mL at Week 4 of treatment
|
4 weeks
|
|
Part 2: Sustained Virological Response (SVR)
Временное ограничение: From drug administration until 12 weeks after end of treatment, up to 52 weeks
|
Part 2: Sustained virological response (SVR), defined as HCV RNA <25 IU/mL and undetectable at 12 weeks after end of treatment
|
From drug administration until 12 weeks after end of treatment, up to 52 weeks
|
|
Part 3 and 4: Sustained Virological Response (SVR)
Временное ограничение: From drug administration until 12 weeks after end of treatment, up to 36 weeks
|
Part 3 and 4: Sustained virological response (SVR) defined as HCV RNA <25IU/mL and undetectable at 12 weeks after end of treatment
|
From drug administration until 12 weeks after end of treatment, up to 36 weeks
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Part 1: Time to Virological Response
Временное ограничение: From drug administration until end of drug administration, up to 4 weeks
|
Part 1: Time to virological response, defined as the timepoint of the first measurement of plasma HCV RNA level <25 IU/mL.
The percentage of participants who achieved virological response within each time period are displayed for this outcome measure.
|
From drug administration until end of drug administration, up to 4 weeks
|
|
Part 2: Time to Virological Response
Временное ограничение: From drug administration until end of drug administration, up to 40 weeks
|
Part 2: Time to virological response, defined as the timepoint of the first measurement of plasma HCV RNA level <25 IU/mL.
The percentage of participants who achieved virological response within each time period are displayed for this outcome measure.
|
From drug administration until end of drug administration, up to 40 weeks
|
|
Part 1 and 2: Plasma HCV RNA Level Not Detectable at Week 4
Временное ограничение: 4 weeks
|
Part 1 and 2: Plasma Hepatitis C Virus Ribonucleic acid (HCV RNA) level not detectable at Week 4
|
4 weeks
|
|
Part 2: Sustained Virological Response at 4 and 24 Weeks After End of Treatment
Временное ограничение: 4 weeks and 24 weeks after the end of treatment, up to 64 weeks
|
Part 2: Sustained virological response at 4 and 24 weeks after end of treatment
|
4 weeks and 24 weeks after the end of treatment, up to 64 weeks
|
|
Part 3 and 4: Plasma HCV RNA Level <25 IU/mL at Week 4 and 12 of Treatment
Временное ограничение: Week 4 and 12
|
Part 3 and 4: Plasma Hepatitis C Virus Ribonucleic acid (HCV RNA) level <25 IU/mL at week 4 and 12 of treatment
|
Week 4 and 12
|
|
Part 3 and 4: Sustained Virological Response (SVR) at 4 Weeks After End of Treatment
Временное ограничение: up to 28 weeks
|
Part 3 and 4: Sustained virological response (SVR) at 4 weeks after end of treatment
|
up to 28 weeks
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- Zeuzem S, Mantry P, Soriano V, Buynak RJ, Dufour JF, Pockros PJ, Wright D, Angus P, Buti M, Stern JO, Kadus W, Vinisko R, Bocher W, Mensa FJ. Short article: Faldaprevir, deleobuvir and ribavirin in IL28B non-CC patients with HCV genotype-1a infection included in the SOUND-C3 phase 2b study. Eur J Gastroenterol Hepatol. 2016 Aug;28(8):923-6. doi: 10.1097/MEG.0000000000000649.
- Asselah T, Zeuzem S, Soriano V, Bronowicki JP, Lohse AW, Mullhaupt B, Schuchmann M, Bourliere M, Buti M, Roberts SK, Gane EJ, Stern JO, Voss F, Baum P, Gallivan JP, Bocher WO, Mensa FJ. ITPA Genotypes Predict Anemia but Do Not Affect Virological Response with Interferon-Free Faldaprevir, Deleobuvir, and Ribavirin for HCV Infection. PLoS One. 2015 Dec 9;10(12):e0144004. doi: 10.1371/journal.pone.0144004. eCollection 2015.
- Zeuzem S, Soriano V, Asselah T, Gane EJ, Bronowicki JP, Angus P, Lohse AW, Stickel F, Mullhaupt B, Roberts S, Schuchmann M, Manns M, Bourliere M, Buti M, Stern JO, Gallivan JP, Voss F, Sabo JP, Bocher W, Mensa FJ; SOUND-C2 Study Group. Efficacy and safety of faldaprevir, deleobuvir, and ribavirin in treatment-naive patients with chronic hepatitis C virus infection and advanced liver fibrosis or cirrhosis. Antimicrob Agents Chemother. 2015 Feb;59(2):1282-91. doi: 10.1128/AAC.04383-14. Epub 2014 Dec 15.
- Zeuzem S, Soriano V, Asselah T, Bronowicki JP, Lohse AW, Mullhaupt B, Schuchmann M, Bourliere M, Buti M, Roberts SK, Gane EJ, Stern JO, Vinisko R, Kukolj G, Gallivan JP, Bocher WO, Mensa FJ. Faldaprevir and deleobuvir for HCV genotype 1 infection. N Engl J Med. 2013 Aug 15;369(7):630-9. doi: 10.1056/NEJMoa1213557.
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Полезные ссылки
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 мая 2010 г.
Первичное завершение (Действительный)
1 октября 2014 г.
Завершение исследования (Действительный)
1 октября 2014 г.
Даты регистрации исследования
Первый отправленный
3 мая 2010 г.
Впервые представлено, что соответствует критериям контроля качества
26 мая 2010 г.
Первый опубликованный (Оценивать)
28 мая 2010 г.
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
1 февраля 2016 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
22 декабря 2015 г.
Последняя проверка
1 декабря 2015 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Заболевания пищеварительной системы
- РНК-вирусные инфекции
- Вирусные заболевания
- Инфекции
- Инфекции, передающиеся через кровь
- Передающиеся заболевания
- Заболевания печени
- Флавивирусные инфекции
- Гепатит, Вирусный, Человеческий
- Гепатит, хронический
- Гепатит
- Гепатит С
- Гепатит С, хронический
- Молекулярные механизмы фармакологического действия
- Противоинфекционные агенты
- Противовирусные агенты
- Антиметаболиты
- Рибавирин
Другие идентификационные номера исследования
- 1241.21
- 2009-018197-66 (Номер EudraCT: EudraCT)
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. .