NCT04885855已完成2 期
Efficacy and Safety of 8- Versus 12-week Sofosbuvir-ravidasvir Treatment of Non-cirrhotic Chronic Hepatitis C Patients: An Open-label, Randomized, Multicenter Study in Malaysia
Muhammad Radzi Abu Hassan1 个研究点 分布在 1 个国家目标入组 322 人开始时间: 2021年3月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 322
- 试验地点
- 1
- 主要终点
- SVR12
研究概览
简要总结
This is open-label, randomized, multicentre study to compare the efficacy and safety of the 8-week versus 12-week of SOF-RVD combination treatment for non-cirrhotic chronic hepatitis C patients.
All the recruited subjects will receive the treatment accordingly and be followed up for 24 weeks following the completion of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has evidence of chronic HCV infection, defined as:
- •a. Positive anti-HCV antibody or detectable HCV RNA or HCV genotype and HCV viral load ≥104 IU/mL within 6 months prior to the time of blood collection for screening.
- •Willing and able to provide written informed consent.
- •Men and women age ≥ 18 years and < 70 years.
- •Body Mass Index (BMI) of 18 to 35 kg/m
- •Intention to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.
- •Women with a negative pregnancy test at screening and baseline assessment.
- •Women of childbearing potential who accept effective contraception from 2 weeks prior to day 1 of study to 1 month after treatment (double contraceptive method including at least one barrier method). A woman is of non-childbearing potential if she (a) reached natural menopause determined retrospectively after 12 months of amenorrhea without any other obvious medical cause or (b) had procedures like bilateral tubal ligation or hysterectomy or bilateral oophorectomy.
- •Subjects who are compliant in opioid substitution maintenance program may be included as long as there is no concern about study medications adherence and interaction or compliance to study schedules.
- •HIV/HCV co-infected patients receiving cART fulfilling the below criteria are eligible for the study:
- •Antiretroviral therapy has been initiated at least 6 months prior to screening (to avoid the possibility of Immune reconstitution inflammatory syndrome - IRIS)
- •Patient has been on the same protocol-approved ARV regimen for ≥ 8 weeks prior to screening and is expected to continue the current ARV regimen through the end of study.
- •HIV ARVs: agents allowed in this study should be administered per the prescribing information in the package insert
- •Screening HIV RNA <50 copies/mL.
- •Screening CD4 cell count ≥100 cells/uL
- •HIV/HCV co-infected patients not receiving cART: Screening CD4 cell count must be ≥ 500 cells/uL
排除标准
- •Has evidence of liver cirrhosis in which, liver cirrhosis is determined by;
- •APRI score of ≥ 1.5,
- •In case where APRI score is >1.0 but <1.5,
- •Perform fibroscan* (where TE ≥12.5 kPa indicates liver cirrhosis) or
- •Calculate FIB-4 index (where ≥3.25 indicates liver cirrhosis) *Depending on availability at facility
- •Current/past history of decompensation including ascites, variceal bleeding, bacterial peritonitis, or hepatic encephalopathy.
- •Additional laboratory exclusion criteria:
- •Direct bilirubin >3x ULN
- •AST, ALT >10x ULN
- •Low neutrophil count (≤599 cells/mm3), haemoglobin (<9.0 g/dL), platelets (<150000 cells/mm3).
- •Patients with serum creatinine >1.5 ULN or end-stage renal disease.2
- •Hepatitis B co-infection (HBsAg positive).
- •Pregnancy, as documented by positive pregnancy tests at screening and baseline assessment.
- •Breastfeeding.
- •Subjects currently receiving or unable to stop the use for at least 1 week prior to receiving the first dose of study drug any medications or herbal supplements known to be potent inhibitors or moderate inducers of cytochrome P450 (CYP) 3A4 and potent inducers of P-glycoprotein. This includes subjects who are on amiodarone or other contraindicated drugs. Refer to www.hep_druginteractions.org, the investigator manual and the investigator's brochure for detailed information.
- •Participation in other clinical trials within 3 months.
- •Any clinically significant findings or unstable condition during the screening, medical history or physical examination that, in the investigator's opinion, would compromise participation in this study. This could include patients with poorly controlled hypertension, asthma, diabetes, or other life-threatening conditions.
- •Current or history of use within the preceding 6 months of immunosuppressive or immune-modulating agents. Corticosteroid used to treat any medical condition are allowed if systemic for not more than 2 weeks or if topical.
- •History of solid organ or bone marrow transplantation.
- •Any prior DAA use or NS5A inhibitors therapy.
- •Patients with significant cardiovascular conditions including myocardial infarction within the previous 6 months or heart failure NYHA class III or IV; history of Torsade de pointes
- •HIV/HCV co-infected patients who are yet to receive stable antiretroviral therapy or for whom ART treatment initiation maybe scheduled during the study period.
研究组 & 干预措施
12-week
Active Comparator
Patient will be receiving treatment of tablet Sofosbuvir 400mg and tablet Ravidasvir 200mg combination once daily for the duration of 12 weeks.
干预措施: Sofosbuvir 400 MG (Drug)
8-week
Experimental
Patient will be receiving treatment of tablet Sofosbuvir 400mg and tablet Ravidasvir 200mg combination once daily for the duration of 8 weeks.
干预措施: Sofosbuvir 400 MG (Drug)
8-week
Experimental
Patient will be receiving treatment of tablet Sofosbuvir 400mg and tablet Ravidasvir 200mg combination once daily for the duration of 8 weeks.
干预措施: Ravidasvir 200mg (Drug)
12-week
Active Comparator
Patient will be receiving treatment of tablet Sofosbuvir 400mg and tablet Ravidasvir 200mg combination once daily for the duration of 12 weeks.
干预措施: Ravidasvir 200mg (Drug)
结局指标
主要结局
SVR12
时间窗: 12 weeks upon completion of treatment
Sustained Virological Response (SVR) at week-12 post treatment, as evidenced by Hepatitis C Viral (HCV) ribonucleic acid (RNA) level less than the lower limit of quantification of 15 IU/mL.
次要结局
未报告次要终点
研究者
Muhammad Radzi Abu Hassan
Consultant Gastroenterologist
Hospital Sultanah Bahiyah
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Simeprevir in Combination With Sofosbuvir in Treatment-Naïve or -Experienced Adults With Chronic Genotype 4 Hepatitis C Virus InfectionChronic Hepatitis CNCT02253550Peter J. Ruane, M.D.30
已完成
3 期
SOF (Sovaldi®) +RBV for 16 or 24 Weeks and SOF+RBV+Peg-IFN for 12 Weeks in Adults With Genotype 2 or 3 Chronic HCV InfectionHepatitis CNCT01962441Gilead Sciences601
已完成
不适用
Safety and Efficacy of Sofosbuvir-based Regimens in Clinical Practice for the Treatment of Chronic Hepatitis C Virus Infection in IndiaHepatitis C VirusNCT02592057Gilead Sciences532
招募中
4 期
Strategic Treatment Reduction in Very Early Liver Disease With 4 Weeks Sofosbuvir Plus Glecepravir-pibrentasvirHepatitis CNCT03855917Kirby Institute30
已完成
2 期
Pilot Study to Assess Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-dose Combination in Treatment Experienced Subjects With Hepatitis C Virus (HCV) Genotype 1 - HIV Co-infectionViral Hepatitis CHIVNCT02125500ANRS, Emerging Infectious Diseases68