EUCTR2009-012344-17-IT进行中（未招募）不适用
A randomized, open label, single center, phase IIa controlled trial to assess tolerability, safety and effect of treatment with deferasirox plus standard antiviral therapy versus standard antiviral therapy in chronic hepatitis C patients na?ve to treatment with interferon and/or ribavirin - ND
AZIENDA OSPEDALIERA POLICLINICO DI MODENA0 个研究点开始时间: 2009年9月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Male or female patients with chronic hepatitis C, genotype 1, candidate to antiviral therapy, viral load ≥ 400,000 IU/ml of viral Hapatitis C RNA at the time of screening only and METAVIR score F0, F1, F2 or F3 Age ≥18 years. HCV-RNA and HCV-antibodies positivity Serum ferritin >100 ng/ml (male) or > 50 ng/ml (female)
- •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
- •Decompensated cirrhosis Prior treatment with standard or pegylated Interferon monotherapy or in combination with ribavirin hemoglobin concentration of less than 12 g per deciliter in women and less than 13 g per deciliter in men Patients with ALT (SGPT) levels > 10 x ULN. White-cell count less than 3000 per cubic millimeter Neutrophil count less than 1500 per cubic millimeter Platelet count less than 90,000 per cubic millimeter TSH alterations HIV infection HBV infection HCC or focal hepatic lesions at the ultrasound examination in the 3 months before alcohol abuse (more than 25 grams per day) Prior organ transplantation Severe psychiatric conditions Seizure disorder Cardiovascular disease Patients with serum creatinine > ULN or with significant proteinuria as indicated by a urinary protein/creatinine ratio ≥ 1.0 in a non-first void urine sample at baseline. Hemoglobinopathy Hemophilia Poorly controlled diabetes mellitus Immunologically mediated diseases Patients with considerable impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral deferasirox / ICL670 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection). History of clinically relevant ocular or ear disorders. Patients with psychiatric or addictive disorders which prevent them from giving their informed consent or undergoing any of the treatment options or patients unwilling or unable to comply with the protocol Patients with a known history of HIV seropositivity (Elisa or Western blot). History of malignancy of any organ system, treated or untreated, within the past 5 years whether there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. Pregnant or nursing (lactating) women are not eligible to participate in the study. Patients participating in another clinical trial or receiving an investigational drug. History of non-compliance with medical regimens or patients who are considered potentially unreliable and/or not cooperative, unwilling or unable to comply with the protocol.
研究者
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