EUCTR2009-018197-66-FR进行中（未招募）1 期
Safety, antiviral effect and pharmacokinetics of BI 207127 in combination with BI 201335 and with ribavirin for 4 (Part 1) and with or without ribavirin for 24-48 weeks (Part 2) in patients with chronic HCV genotype 1 infection (randomized, open label, Phase II)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 707
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 HCV serology test (HCV Ab positive) or detectable HCV RNA at least 6 months prior to screening, or by a liver biopsy typical of chronic hepatitis C in combination with positive HCV serology
- •2)HCV infection of genotype 1 (1a or 1b) confirmed by genotypic testing at screening.
- •3)Treatment naive, defined as no prior treatment with any interferon, pegylated interferon, and /or ribavirin and no prior treatment with at least one dose of any direct antiviral agent for acute or chronic hepatitis C infection
- •4)Plasma HCV RNA = 100,000 IU/mL at screening
- •5)Liver biopsy within two years or fibroscan within six months prior to screening that excludes cirrhosis.
- •6)Age 18 – 75 years
- •7)Female patients who are infertile or who are of childbearing potential with a negative pregnancy test and agreeing to abstain from intercourse or to use one accepted method of birth control in addition to the use of a condom, OR
- •Male patients who are sterile, or who agree to abstain from intercourse or who use a condom while their female partners use one medically accepted method of birth control
- •8)Signed informed consent form prior to trial participation
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Hepatitis C infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening
- •2) Evidence of liver disease due to causes other than chronic HCV infection
- •3) Positive ELISA for HIV-1 or HIV-2
- •4) Hepatitis B virus (HBV) infection based on presence of HBs-Ag
- •5) Decompensated liver disease, or history of decompensated liver disease
- •6) 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)
- •7) Patients with ongoing or historical photosensitivity or recurrent rash
- •8) History of alcohol or drug abuse (except cannabis) within the past 12 months
- •9) Body mass index <18 or > 35 kg/m2
- •10) Usage of any investigational drugs within 30 days prior to enrolment, or 5 half-lives, whichever is longer; or the planned usage of an investigational drug during the course of the current study
- •11) Known hypersensitivity to any ingredient of the study drugs
- •12) A condition that is defined as one which in the opinion of the investigator may either interfere with the patient’s capability for participation in the trial or may influence the results of the trial or the patient’s ability to participate in the trial.
- •13) 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 (e.g., ultrasound, CT scan, MRI) within 6 months prior to randomisation
- •14) Total bilirubin > 1.5 x ULN with ratio of direct/indirect > 1
- •15) AST or ALT > 5 x ULN
- •16) Prothrombin time INR (International Normalised Ratio) prolonged to >1.5 xULN
- •17) Requirement for chronic systemic corticosteroids (nasal or pulmonary steroids will be allowed)
- •18) Received concomitant systemic antiviral, hematopoietic growth factor, or
- •immunomodulatory treatment with 30 days prior to enrolment or 5 half-lives,
- •whichever is longer; patients being treated with oral antivirals such as acyclovir,
- •famcyclovir, valcyclovir for mild, localised recurrent herpes simplex infection, or
- •with oseltamivir and zanamivir for Influenza A may be enrolled.
- •19) Received silymarin (milk thistle) or glycyrrhizin or Sho-saiko-to (SST) within 30 days prior to enrolment
- •20) Hemoglobin <12.0g/dL for women and <13.0g/dL for men
- •21) White blood cell count <2,000 cells/mm3
- •22) Absolute neutrophil count < 1,500 cells/mm3
- •23) Platelet count < 100,000 /mm3
- •24) Creatinine > 1xULN
- •25) HbA1c > 7.5%
- •26) TSH and T4 outside normal limits (accepted if thyroid function adequately
- •controlled)
- •27) Chronic obstructive pulmonary disease
- •28) Screening ECG with any abnormalities suggestive of prior or active
- •cardiovascular disease
- •29) Chronic cardiac disease (e.g., coronary artery disease, congestive heart failure,
- •uncontrolled hypertension, significant arrhythmia)
- •30) Autoimmune disease, including autoimmune hepatitis
- •31) Hemoglobinopathy (e.g., thalassemia major or sickle cell anemia)
- •32) Glucose-6-phosphate dehydrogenase deficiency
- •33) History of moderate, severe or uncontrolled psychiatric disease, especially
- •depression, including a history of hospitalization or prior suicidal attempt
- •34) Abnormal findings in fundoscopy precluding IFN treatment within 6 months prior to randomisation
- •35) Organ transplant history, other than cornea or hair
- •36) Active seizure disorder within the past 2 years; patients may be enrolled if on stable medication and seizur
研究者
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