ISRCTN16857338已完成未知
Response guided therapy with sofosbuvir and velpatasvir for 12 or 24 weeks in patients with genotype 3 chronic hepatitis C virus: is longer therapy worthwhile?
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Voluntarily signed informed consent form
- •2. Aged 18 years or older
- •3. Chronic HCV infection, defined by anti-HCV antibody or HCV RNA detection for greater than 6 months
- •4. Infected with genotype 3 HCV (identified by referring hospital)
- •5. Meets NHS England treatment criteria to commence sofosbuvir/velpatasvir
- •6. Pre-treatment HCV RNA >10,000 iu/mL (can be any time before treatment week 0)
- •7. HCV RNA > or equal to 30 iu/mL at treatment week 2 (+/- 3 days)
- •8. Has cirrhosis defined by: evidence of portal hypertension, OR APRI >2 plus AST:ALT ratio >1, OR radiological evidence of cirrhosis, OR fibroscan score >11.5kPa, OR liver biopsy showing cirrhosis
- •9. Patients with decompensated cirrhosis (variceal bleeding, ascites and encephalopathy) can be included
- •10. Patients with malignancy including hepatocellular carcinoma can be included
- •11. Patients with liver transplant can be included
- •12. Patients coinfected with chronic hepatitis B virus or human immunodeficiency virus can be included
- •13. Female subjects of childbearing potential must have documented negative pregnancy test prior to enrolment (negative urinary pregnancy test), and if engaged in heterosexual intercourse must use protocol specified method of contraception (see below) during study drug treatment and for 30 days after last dose
- •14. Male subjects engaged in heterosexual intercourse with a female of childbearing potential should protocol specified method of contraception during study drug treatment and for 30 days after last dose
排除标准
- •1. Any of the above inclusion criteria not met
- •2. Any of the following criteria excludes a subject from enrolling into this study
- •3. Clinically-significant medical or psychiatric illness (other than chronic HCV) in the past, present, or being evaluated, that may interfere with participant treatment, safety, assessment or compliance with the protocol.
- •4. Severe renal impairment with eGFR <30 mL/min/1.73m2 or requiring dialysis
- •5. Alcohol consumption or illicit drug abuse likely to interfere with participant treatment, safety, assessment or compliance with protocol, as deemed by the investigator
- •6. Previous exposure to sofosbuvir (or other NS5B inhibitor) or NS5A inhibitor
- •7. Severe allergy to study drugs, its metabolites or formulation excipient (see SmPC for details)
- •8. Any investigational medicinal product = 6 weeks prior to treatment start
- •9. Pregnant or nursing female, or males wishing to conceive during the period of study treatment + 30 days after
- •10. Patients who adhered to less than 90% of prescribed sofosbuvir/velpatasvir at screening
- •11. In accordance with the SmPC of sofosbuvir/velpatasvir concomitant use of the following medications are contraindicated:
- •11.1. Anticonvulsants - carbamazepine, phenytoin, phenobarbital, oxcarbazepine
- •11.2. Antimycobacterials – rifampicin, rifabutin, rifapentine
- •11.3. Antiretrovirals - efavirenz
- •11.4. St John’s wort
- •11.5. Modafinil
- •11.6. Proton-pump inhibitors should be avoided and if necessary, should be administered 4 hours after at maximum doses equivalent to 20mg omeprazole per day
- •11.7. Amiodarone should be avoided and if necessary, close monitoring is required
- •12. Using effective contraception if of child-bearing potential
研究者
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