EUCTR2012-003533-41-IE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 in Treatment-Naïve Patients with Chronic Genotype 1 HCV Infection
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 460
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 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 sub-GT1b confirmed by genotypic testing at screening.
- •3. Treatment naïve defined as:
- •a. no prior treatment with any interferon, pegylated interferon, and /or ribavirin
- •b. no prior treatment with at least one dose of any other licensed or investigational
- •antiviral agent of for acute or chronic hepatitis C infection
- •4. Plasma HCV RNA = 1,000 IU/mL at screening
- •5. Liver biopsy within three years or fibroscan within 6 months prior to randomisation.
- •Note: patients with a liver biopsy performed 3 or more years or fibroscan performed 6
- •months or more prior to randomisation demonstrating cirrhosis do not need to repeat a
- •liver biopsy or fibroscan. Patients with a liver biopsy performed 3 or more years (or
- •fibroscan performed 6 months or more) prior to randomisation, negative for the presence
- •of cirrhosis need to repeat the liver biopsy or fibroscan, with the result available before
- •randomisation visit.
- •6. Age 18 – 75 years (inclusive)
- •7. Female patients with a negative urine pregnancy test (dipstick) at Visit 2 prior to randomisation:
- •a. with documented hysterectomy, OR
- •b. who have had both ovaries removed, OR
- •c. with documented tubal ligation, OR
- •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 on Day 1
- •(Visit 2), that agree to use two non-hormonal methods of birth control from the date
- •of screening until 7 months after the last dose of ribavirin. They must not breast-feed
- •at any time from the date of screening until 7 months after the last dose of ribavirin.
- •Accepted methods of contraception for females in this trial are diaphragm with
- •spermicide substances, intrauterine devices, cervical caps 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
- •Male patients
- •a.who are documented to be sterile, OR
- •b. who consistently and correctly use a condom while their female partners (if of
- •child-bearing potential) agree to use one of the appropriate medically accepted
- •methods of birth control from the date of screening until 7 months after the last dose
- •of ribavirin, AND
- •c. without pregnant female partners. It is in the responsibility of the male patient to
- •ensure that his partner (or partners) is not pregnant prior to enrolment into the study
- •or becomes pregnant during the treatment and follow-up phase. Female partners of
- •childbearing potential must perform monthly pregnancy tests from the date of
- •screening until 7 months after the last dose of ribavirin (tests will be provided by the
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 415
- 另有 2 项未显示
排除标准
- •1. HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing
- •at screening
- •2. HCV subtype 1a, mixed 1a/1b and GT1 undefined.
- •3. Evidence of liver disease mainly due to causes other than chronic HCV infection
- •such as autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis or
- •Wilson’s disease.
- •Note: patients with steatosis as part of the histologic findings on liver biopsy are not
- •4. HIV-1 or HIV-2 infection
- •5. Hepatitis B virus (HBV) infection based on presence of HBs-Ag
- •6. Evidence of decompensated liver disease, or history of decompensated liver disease,
- •defined as history of ascites, hepatic encephalopathy, bleeding esophageal varices or
- •any other evidence of previous decompensation
- •7. International Normalized Ratio (INR) of =1.7
- •8. Serum albumin =3.3 g/dL
- •9. Serum total bilirubin >2.0 times the upper limit of normal (ULN), unless history of
- •Gilbert’s disease
- •10. Active or suspected malignancy or history of malignancy within the last 5 years
- •(with the exception of appropriately treated basal cell carcinoma of the skin or in situ
- •carcinoma of the uterine cervix)
- •11. Patients with ongoing or historical photosensitivity or recurrent rash
- •12. Alcohol or drug abuse (except cannabis) within the past 12 months
- •13. Body mass index <18 or > 35 kg/m2
- •14. Usage of any investigational drugs within 28 days prior to randomisation, or the
- •planned usage of an investigational drug during the course of the current study
- •15. Known hypersensitivity to any ingredient of the study drugs
- •16. 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
- •17. Alpha fetoprotein value >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
- •18. A history of severe pre-existing cardiac disease, including unstable or uncontrolled
- •cardiac disease (e.g. congestive heart failure, myocardial infarction, unstable angina
- •and arrhythmic disorders) current or within the previous 12 months before
- •randomisation
- •19. Received concomitant hematopoietic growth factor, or immunomodulatory treatment
- •within 28 days prior to randomisation
- •20. 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
- •The following exclusion criteria are potential contraindications for the use of PegIFN
- •+/- RBV (for rationale please cf. Section 3.2)
- •21. Pre-existing psychiatric conditions including but not limited to severe depression or
- •hospitalization for depression, suicidal ideation and attempted suicide, schizophrenia,
- •bipolar illness, severe anxiety or personality disorder, a period of disability or
- •impairment due to a psychiatric disease current or within the previous 3 years before
- •randomisation
- •22. Abnormal thyroid function that cannot be controlled effectively by medication
- •23. Active autoimmune-mediated disease known to be exacerbated by peginterferon
- •therapy (e.g., Crohn’s disease, ulcerative colitis, idiopathic thrombocytopenic
- 另有 1 项未显示
研究者
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