EUCTR2009-012782-63-FR进行中（未招募）1 期
Boceprevir and Peginterferon/Ribavirin for the Treatment of Chronic Hepatitis C in Treatment-Naive Subjects: A Comparison of Erythropoietin Versus Ribavirin Dose Reduction for the Management of Anemia
Schering-Plough Research Institution, A Division of Schering Corporation0 个研究点目标入组 660 人开始时间: 2009年11月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 660
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
入选标准
- •Inclusion Criteria for CHC
- •1. Subject must have previously documented CHC genotype 1 infection.
- •Subjects with other or mixed genotypes are not eligible. The HCV-RNA result
- •obtained from the central laboratory at the Screening Visit must confirm
- •genotype 1 infection and be =10,000 IU/mL.
- •2. Hemoglobin concentration at Screening must be =15 g/dL for both females
- •and males and will be strictly observed.
- •3. Subject must have a liver biopsy with histology consistent with CHC and no
- •other etiology. Copies of the pathology report and histology slides (suitable
- •for evaluation by the trial central pathologist) are required for the subject to be
- •included in the trial. The slides and the pathology report must be accessible
- •by the trial site prior to Day 1. Using the Scoring Systems for Hepatic Fibrosis, the investigator must determine the level of fibrosis demonstrated by the biopsy.
- •a. For subjects with fibrosis F0-3 the biopsy must have been obtained
- •within 3 years of the screening visit. If the timing of the liver biopsy
- •does not meet this criterion, the liver biopsy may be performed
- •between Screening and Day 1 (only if the subject’s Screening Visit
- •confirms that the subject meets the other trial inclusion criteria).
- •b. For subjects with F4 (cirrhosis), any historic liver biopsy demonstrating
- •cirrhosis will be accepted regardless of length of time since biopsy.
- •Two unstained slides are preferred for reading by the central pathologist
- •selected by the sponsor; however, one slide stained with hematoxylin plus
- •eosin (H & E) plus one slide stained with Masson’s trichrome will be accepted
- •(slides should be reviewed by the investigator to confirm adequacy). The
- •central pathologist reading will be used for analysis purposes only; Day 1
- •procedures will be performed based upon the local report.
- •4. Subjects with bridging fibrosis (F3) or cirrhosis (F4) must have an ultrasound
- •within 6 months of the Screening Visit (or between Screening and Day 1) with
- •no findings suspicious for hepatocellular carcinoma (HCC).
- •5. Subject must be =18 years of age.
- •6. Subject’s weight must be =40 kg and =125 kg.
- •7. Subject and subject’s partner(s) must each agree to use acceptable methods
- •of contraception as specified for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations.
- •8. Subjects must be willing to give written informed consent.
- •9. Subjects must be willing to attend frequent site visits for the duration of the
- •10. Subjects must not have any contraindications for the use of erythropoietin.
- •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
排除标准
- •1. Coinfected with HIV or hepatitis B
- •2. Prior treatment for HCV; except herbal remedies, except those with hepatotoxicity. Herbal remedies must be discontinued, except silymarin
- •3. Any investigational drug within 30 days
- •4. Receiving any of the following medication within 2 weeks: alfuzosin, antiarrhythmics (amiodarone, bepridil, flecainide,propafenone, and quinidine), ergot derivatives, cisapride, lovastatin, simvastatin,pimozide, triazolam, and orally administered midazolam.
- •5. Participation in other clinical trial within 30 days or intention to participate during this trial. Collection of additional blood, urine, or tissue samples beyond that specified, is prohibited (unless related to the subject’s medical care)
- •6. Decompensated liver disease including, clinical ascites, bleeding varices, or hepatic encephalopathy
- •7. Diabetic or hypertensive with significant ocular examination findings: retinopathy, cotton wool spots, optic nerve disorder, retinal hemorrhage, or any other significant abnormality
- •8. Pre-existing psychiatric condition(s), including:
- •a. Moderate or severe depression.
- •b. Depression associated with:
- •i. Hospitalization
- •ii. Electroconvulsive therapy
- •iii. Prolonged absence from work or significant disruption of daily functions
- •c. Suicidal or homicidal ideation or attempt
- •d. Severe psychiatric disorders (not limited to schizophrenia, psychosis, bipolar disorder, post-traumatic stress disorder or mania)
- •e. Lithium use
- •f. Antipsychotic drug use
- •9. Substance abuse of specified drugs within specified timeframes (not including time spent in detoxification, hospitalization, or incarceration):
- •a. Alcohol, IV drugs, inhalational (not marijuana), psychotropics, narcotics, cocaine use, prescription or over-the-counter drugs: within 1 year
- •b. Multi-drug abuse within 3 years
- •c. Receiving opiate agonist substitution therapy within 1 year (unless monitored in an opioid substitution maintenance program)
- •d. Marijuana use is excessive or interfering with daily function. Discontinue any recreational marijuana
- •10. Pre-existing medical condition that could interfere with participation/completion of the trial:
- •a. CNS trauma requiring intubation, intracranial pressure monitoring, brain meningeal or skull surgery, or resulting in seizure, coma, permanent neurologic deficits, abnormal brain imaging, or CSF leak. Prior brain hemorrhage or intracranial aneurysms b. Seizure disorder unless seizure was >10 years ago, a single isolated event, no medications prescribed, and a normal neurological examination is documented
- •c. Stroke or transient ischemic attack
- •d. Immunologically mediated disease, celiac disease, rheumatoid arthritis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, sarcoidosis, severe psoriasis, or symptomatic thyroid disorder
- •e. Chronic pulmonary disease
- •f. Significant cardiac abnormalities/dysfunction including uncontrolled hypertension or use of antianginal agents
- •g. Medical condition requiring chronic systemic cortico
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