EUCTR2008-000495-24-DE进行中（未招募）不适用
A Multicenter, Open-Label, Pilot Study to Explore the Safety and Efficacy of Intravenous Bortezomib in Patients with Hepatitis C - ViroLogik CT-02
适应症
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
- 10
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. Male and females aged <18 years
- •2. CD4-counts > 250/µl
- •3. Documented laboratory diagnosis of HCV infection with detectable viral load
- •4. Not tolerating or responding to hepatitis C treatment with interferon and ribavirin
- •5. No treatment with a HCV active antiviral therapy such as ribavirin and/or interferon =28 days before Baseline
- •6. Serum HCV ribonucleic acid (RNA) levels > 100 000 copies/mL
- •7. Patients without relevant uncontrolled infections and in good general health
- •8. Patients without clinically significant abnormalities at physical examination, vital signs, ECG and laboratory parameters, which may in the judgment of the Investigator/principal Investigator, interfere with the safety of the patient or confound the objectives of the study
- •9. Normal renal function defined as renal clearance >= 80 mL/min (according to Cockroft & Gault formula at Screening)
- •10. Negative urine pregnancy test (females of childbearing potential only)
- •11. Women who are post-menopausal (natural menopause established in retrospect after 12 consecutive months of amenorrhoea without hormone replacement therapy during the last 5 months), surgically sterilized or using a highly effective method of contraception (an implanted or injected hormonal contraceptive, some intrauterine contraceptive devices (IUDs) containing hormones, sexual abstinence, or have a vasectomised partner). Females using combined oral contraceptives should use a different or additional highly effective method of contraception as listed above
- •12. Willingness to use highly effective contraception (double barrier method) by both males and females while on study treatment and for 3 months following Bortezomib treatment
- •13. The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
- •14. Liver biopsy at any time prior to enrollment with a pathology report confirming the histological diagnosis consistent with chronic hepatitis
- •15. HIV test performed at screening day with negative result
- •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. Patients with a familiar history of, a known hypersensitivity or multiple allergies toward drugs, especially hypersensitivity to Bortezomib, boron or mannitol
- •2. Uncontrolled infection or any chronic infection which requires acute treatment
- •3. Patients with clinically significant gastrointestinal, renal, hepatic, respiratory, cardiovascular, metabolic or hormonal disorders
- •4. Patient having experienced cerebral seizures in the past
- •5. Active or past abnormal function of peripheral nervous system (polyneuropathy)
- •6. Patients with a present condition, which may alter the pharmacokinetics of a drug, including but not limited to blockers and inducers of cytochrome P450 3A and 2C19 such as HIV 1 PIs, HIV-1 NNRTIs, rifampicin or carbamazepin.
- •7. Renal dysfunction defined as creatinine clearance <80mL/min (acc. to the Cockcroft & Gault formula) at Screening
- •8. Hepatic dysfunction defined as follows:
- •Alanine aminotransferase (AL(A)T) and aspartate aminotransferase
- •AS(A)T) >3 x upper limit of the normal range (ULN)
- •Total bilirubin >1.5mg/dL
- •9. Abnormal haematologic function (absolute neutrophil count (ANC) <2000/mm3; platelets <150,000/mm3 [±15%] or haemoglobin <12.0g/dL)
- •10. Low blood pressure (< 110 mm Hg systolic blood pressure) and patients with history of syncope
- •11. Patients receiving ongoing therapy, or therapy within 7 days of study enrolment, with any of the drugs outlined in Section 6.7
- •12. Pregnant women or women who are breast-feeding
- •13. Positive drug test before administration of study medication for the following: cocaine, amphetamines, opiates, ethanol > 0.5 pro mille
- •14. Current alcohol or substance abuse judged by the Investigator to potentially interfere with patient compliance
- •15. Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the dosing requirements
- •16. CD4 counts = 250/µL
- •17. Participation in a study of an investigational drug or device concomitantly or within 30 days prior to this study
- •18. Patients thought to be unreliable or incapable of complying with the requirements of the protocol
- •19. Patient is relative of, or staff directly reporting to the investigator
- •20. Patient is employee of the sponsor.
研究者
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