EUCTR2012-003535-27-IT进行中（未招募）不适用
A phase III randomised, partially double-blind and placebo-controlled study of BI 207127 in combination with faldaprevir and ribavirin for chronic genotype 1 hepatitis C infection in an extended population of treatment naïve patients that includes those ineligible to receive peginterferon
BOEHRINGER ING.0 个研究点目标入组 835 人开始时间: 2012年10月19日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 835
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Chronic hepatitis C infection, diagnosed by positive anti-HCV
- •antibodies and detected HCV RNA at screening in addition to at least one
- •of the following:
- •a. positive anti-HCV antibodies or detected HCV RNA at least 6 months
- •prior to screening, or
- •b. liver biopsy indicating chronic HCV infection, or
- •c. history of elevated alanine aminotransferase (ALT) levels at least 6
- •months prior to screening.
- •2. HCV infection of:
- •a. sub-GT1b confirmed by genotypic testing at screening; or,
- •b. sub-GT1a, GT1(with undefined subtype), or mixed sub-GT1a/1b
- •confirmed by genotypic testing at screening in patients with IL-28b CC
- •3. HCV viral load >= 1,000 IU/mL at randomisation.
- •4. Patients who have never been previously treated with interferon
- •alone, interferon+RBV, PegIFN+RBV or PegIFN+RBV+an
- •investigational/approved DAA or any other HCV treatment regimen.
- •5. Results of the IL-28b genotyping (rs12979860 polymorphism) at
- •randomisation.
- •6. Availability of a liver biopsy within 3 years or fibroscan within 6
- •months prior to randomisation.
- •7. Age 18 to 75 years (inclusive).
- •8. Female patients:
- •a. with documented hysterectomy,
- •b. who have had both ovaries removed,
- •c. with documented tubal ligation,
- •d. who are post-menopausal with last menstrual period at least 12
- •months prior to screening, or
- •e. of childbearing potential with a negative serum pregnancy test at
- •screening and Day 1, who, if sexually active, agree to use two nonhormonal
- •methods of birth control from the date of screening until 7
- •months after the last dose of RBV. Patients must agree not to breastfeed
- •at any time from the date of screening until 7 months after the last
- •dose of RBV. Accepted methods of contraception in the study include
- •diaphragm with spermicidal substance, cervical caps, intrauterine
- •devices and condoms. Note: Systemic hormonal contraceptives may not
- •be as effective in women taking BI 207127/FDV combination therapy
- •and are not accepted methods of contraception in the study.
- •Male patients:
- •a. who are documented to be sterile, or
- •b. who are without pregnant female partner(s) and consistently and
- •correctly use a condom while their female partner(s) (if of child-bearing
- •potential) use one of the appropriate medically accepted methods of
- •birth control from the date of screening until 7 months after the last
- •dose of RBV. It is in the responsibility of the male patient to ensure that
- •his partner(s) is not pregnant prior to screening into the study or
- •becomes pregnant during the treatment and the observation phase.
- •Female partners of childbearing potential should perform monthly
- •pregnancy tests from the date of screening until 7 months after the last
- •dose of RBV (tests will be provided by the sponsor).
- •9. Signed informed consent form prior to trial participation
- 另有 6 项未显示
排除标准
- •1. HCV infection of mixed GT (1/2, 1/3, and 1/4) diagnosed by genotypic
- •testing at screening.
- •2. HCV infection of sub-GT1a in patients with IL-28b CT or TT (non-CC
- •polymorphisms).
- •3. Liver disease due to causes other than chronic HCV infection which
- •may include but is not limited to hemochromatosis, Wilson's disease, or
- •autoimmune liver diseases. Note: patients with steatosis as part of the
- •histological findings of the liver biopsy are not excluded.
- •4. HIV infection.
- •5. Hepatitis B virus (HBV) infection based on presence of HBs-Ag.
- •6. Confirmed or suspected 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).
- •7. History of illicit drug abuse other than cannabis or chronic alcohol abuse within 12 months prior to randomisation.
- •8. Subject is not willing to comply with the precautionary measures to
- •prevent photosensitivity (avoid excessive sun exposure and use sun
- •block on a daily basis).
- •9. A condition that is insufficiently diagnosed, treated or clinically
- •unstable which in the opinion of investigator may put the patient at risk
- •because of participation in this study, influence the results of this study,
- •or limit the patient's ability to participate in this study, including but not
- •limited to severe chronic obstructive pulmonary disease, uncontrolled
- •psychiatric disease.
- •10. Decompensated liver disease, or history of decompensated liver
- •disease, as evidenced by ascites, hepatic encephalopathy, history of
- •esophageal variceal bleeding, or any other evidence of previous
- •decompensation.
- •11. Total bilirubin >2 mg/dL with ratio of direct/indirect >1.
- •12. Serum albumin <=3.5 g/dL.
- •13. Prothrombin time Institutional Normalised Ratio (INR) >=1.7.
- •14. Clinical evidence of unstable cardiovascular disease which may
- •further decompensate due to anemia, including unstable angina, recent
- •myocardial infarction, cardiomyopathy, congestive heart failure,
- •uncontrolled hypertension or significant arrhythmia.
- •15. Red blood cell (RBC) disorders which include but are not limited to:
- •thalassemia major, sickle cell anemia or G6PD deficit. Patients with
- •traits or minor diseases (e.g. sickle cell trait or thalassemia minor) may
- •be enrolled if the disease did not result in anemia at screening,
- •according to the investigator's clinical judgment.
- •16. Body weight <40 kg or >125 kg.
- •17. Usage of any investigational drugs within 28 days prior to
- •randomisation, or planned usage of an investigational drug during the
- •course of this study.
- •18. Received concomitant hematopoietic growth factor within 28 days
- •prior to enrolment.
- •19. Received silymarin (milk thistle), glycyrrhizin, Sho-saiko-to (SST) or
- •any medication listed in a restricted medication list provided in ISF
- •within 28 days prior to randomisation, with the exception of parenteral
- •analgesics used during liver biopsy procedure.
- 另有 8 项未显示
研究者
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