EUCTR2012-000955-15-IT进行中（未招募）不适用
A phase IIa open-label, single arm, multi-center trial evaluating the safety of standard antiviral therapy (pegylated interferon and ribavirin) plus deferasirox in thalassemia patients with transfusion dependent iron overload and chronic hepatitis C
AZIENDA OSPEDALIERA POLICLINICO DI MODENA0 个研究点开始时间: 2012年9月26日最近更新:
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
- •- Age =18 years; - ß-thalassemia patients with transfusional iron overload: Iron overload: ? 20 units (about 100 ml/kg) of packed red blood cells received or when there is evidence from clinical monitoring that chronic iron overload is present (e.g. serum ferritin >1,000 µg/l); - Patients previously treated with any iron chelator (deferoxamine, deferiprone, deferasirox) and already receiving deferasirox at least two months before study start; - Cardiac MRI T2* >15msec; - LVEF at MRI =56%; -Adult male or female patients with diagnosis of chronic hepatitis C (HCV-RNA and HCV-antibodies positivity), any genotype, candidate to antiviral therapy; - Women of childbearing potential should use a valid contraceptive method; - Written Informed Consent obtained from the patient.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 39
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •- Decompensated cirrhosis;- Patients with ALT 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 (with or without HRT);- HBsAg positive / HIV seropositivity (Elisa or Western blot);- HCC or focal hepatic lesions at the ultrasound examination in the 3 months before; - Alcohol abuse (more than 25 grams per day); - Prior organ or HSC transplantation; -Severe psychiatric conditions; - Seizure disorder or other conditions contraindicated to receive peg-IFN and/or Ribavirin, such as history or clinical evidence of chronic pulmonary disease, history of immunologically mediated disease, history of ophthalmologic disorders, history of organ transplantation other than cornea or hair transplant, history of known coagulopathy including hemophilia; - Active cardiovascular disease (heart failure or malignant arrhythmias); - Poorly controlled diabetes mellitus; - Patients with considerable impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral deferasirox (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection); - History of galactose intolerance, lactase deficiency or glucose-galactose malabsorption; - History of hypersensitivity to any of the study drugs or to drugs with similar chemical structure; - Received concomitant systemic antibiotics, antifungals or antivirals for the treatment of active infection within 14 days prior to baseline; - Received systemic corticosteroids (prednisone equivalent of >10mg/day) within 14 days prior to baseline; - Active inflammatory disease that may interfere with accurate measurement of serum ferritin; - 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; - History of malignancy of any organ system, treated or untreated, within the past 5 years, regardless of 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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