EUCTR2015-001956-31-DK进行中（未招募）1 期
Direct acting antiviral therapy of hepatitis C in Denmark: treatment response, adverse events and resistance associated variants
Department of Infectious Diseases, Copenhagen University Hospital, Hvidovre.0 个研究点目标入组 111 人开始时间: 2015年6月10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
- 111
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
- •Patients of both sexes between 18-70 years
- •Patients are followed at one of the 18 departments affiliated with DANHEP, diagnosed with chronic HCV infection (verified by real-time PCR as the presence of HCV RNA in two blood samples taken 6 months apart).
- •Treatment-naïve or previous treatment with pegylated interferon / ribavirin or discontinuing treatment with pegylated interferon / ribavirin / telaprevir / boceprevir due to side effects.
- •Treatment demanding chronic hepatitis C virus infection.
- •Liver biopsy or Fibroscanning showing moderate to severe fibrosis (Metavir =F2 score) or cirrhosis. Liver fibrosis or cirrhosis examined by liver biopsy ranked by the Danish scoring system based on the Metavir scoring system, where stage F2 indicate moderate fibrosis stage F3; severe fibrosis and stage F4; cirrhosis. If the diagnosis is made with Fibroscanning; values> 7 kPa and <17kPa indicate moderate to severe fibrosis and values =17 kPa indicate cirrhosis.
- •- Clinically diagnosed cirrhosis in the absence of liver biopsy or Fibroscanning, defined as overt cirrhosis at ultrasound (+/- spleen enlargement), low platelet count =110 * 109 cells / L, PT=75 / INR> 1.7 (increased clotting of the blood) , serum albumin <6g / L or the presence of complications: ascites confirmed by ultrasound, esophageal varices diagnosed by gastroscopy or hepatic encephalopathy.
- •Infected with genotype 1 or genotype 3.
- •Women of childbearing potential must use effective contraception defined as copper or progesten spiral and condom must be used by partner throughout the treatment period.
- •Men who are treated in the trial must use condoms throughout treatment and for at least 7 months after completion of treatment.
- •Must be able to read and understand Danish.
- •Must be able to sign informed consent.
- •patients co-infected with HIV must be in anti-viral therapy.
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 11
排除标准
- •Hypersensitivity to any of the ingredients in the medicine.
- •Severe untreated psychiatric illness which the investigator believe may affect treatment.
- •Severe mental illness; schizophrenia, psychosis, bipolar disorder, post-traumatic stress disorder, mania.
- •Current alcohol (> 25 objects weekly), intravenous drug or other drug abuse.
- •Decompensated cirrhosis.
- •Diagnosed with hepatocellular carcinoma or are being investigated for this.
- •Severe heart failure NYHA class III and IV
- •Previous stroke, TIA or AMI.
- •Severe angina pectoris, cardiomyopathy, pulmonary hypertension, uncontrolled hypertension or significant arrhythmia diagnosed by ECG.
- •Severe chronic lung disease; COPD, pulmonary fibrosis or sarcoidosis defined as; GOLD stage 3: FEV1 / FVC <0.7 and FEV1 between 30-50% predicted and GOLD stage 4: FEV1 / FVC <0.7 and FEV1 between the 30% predicted.
- •Myelodysplastic diseases.
- •Organ transplantation (except from hair or cornea)
- •Active cancer or diagnosed with cancer (other than basal cell skin cancer) within the past 5 years.
- •Autoimmune liver disease.
- •Haemoglobinopathies; sickle cell anemia and thalassemia.
- •Neutropenia <1.5 x 103 l
- •Thrombocytopenia <50 x 103 ul
- •Renal impairment (GFR <50 ml / min., Including hemodialysis)
- •thyroid disease that is not controlled by conventional therapy.
- •Insufficient treated epilepsy.
- •Pregnancy / lactation.
- •Severe untreated anemia, hemoglobin = 5 mmol / l.
- •Treatment with carbamazepine, phenytoin, rifabutin, rifampicin, herbal preparations containing St. John's wort and modafinil.
- •Insufficient treated severe diabetes, HbA1c> 8.5%.
- •Severe hepatic impairment (Child-Pugh C).
- •The use of contraceptives with ethinylestradiol
- •Treatment with CYP3A4 substrates; Alfuzosin, amiodarone, Atorvastatin, ergotamine, Fusidic acid, Lovastatin, Oral midazolam, pimozide, Quetiapine, Salmeterol, Sildenafil against pulmonary arterial hypertension, Simvastatin, Triazolam, Rosuvastatin.
- •Treatment with potent CYP3A4 inducers or other enzyme inducers; Efavirenz, etravirine, Enzalutamid, Mitotane, Nevirapine, Phenobarbital.
- •The treatment with strong CYP3A4 inhibitors; Clarithromycin, Cobicistat, itraconazole, lopinavir / ritonavir, posaconazole, voriconazole.
- •Treatment with strong CYP2C8 inhibitors; Gemfibrozil.
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