CTRI/2023/11/059507招募中2 期
A phase 2, open-label study to assess the safety and efficacy of Bemnifosbuvir (bem) and Ruzasvir (rzr) in subjects with chronic hepatitis c virus (hcv) infection
试验速览
- 阶段
- 2 期
- 状态
- 招募中
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
入选标准
- •Willing and able to provide written informed consent
- •- Male or female subjects between = 18 years of age (or the legal age of consent per local regulations) and = 85 years of age
- •- Fridericia-corrected QT (QTcF) interval = 440 ms for males and = 460 ms for females at Screening Note: The mean of the triplicate readings should be used to assess the QTcF.
- •- Female subjects of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or to the use of an acceptable effective contraception, as described in Section 5.9
- •- Females must have a negative pregnancy test at Screening and at Day 1 prior to dosing
- •- Subjects must be direct-acting antiviral (DAA)-treatment-naïve, defined as never exposed to an approved or experimental DAA for HCV Note: Prior exposure to (peg)interferon with or without ribavirin is acceptable, as long as it/they were not administered with a DAA.
- •-Subjects must have HCV GT1, GT2, GT3, GT4, GT5, GT6, or GT7 (with no evidence of non-typeable or mixed GT), documented at Screening.
- •- Documented medical history compatible with chronic HCV, including any one of the following:
- •- positive for anti-HCV antibody, HCV RNA, or an HCV GT at least 6 months prior to Day 1, or
- •-positive for anti-HCV antibody at Screening with clinical or laboratory evidence of chronic HCV disease, such as the presence of fibrosis by biopsy or noninvasive tests
- •- HCV RNA = 1,000 IU/mL at Screening.
- •- Liver disease staging assessment as follows:
- •-Absence of cirrhosis (F0 to F3) defined as any one of the following:
- •- Liver biopsy within 24 months of Day 1 showing absence of cirrhosis
- •- Fibroscan® within 12 months of Day 1 with a result of = 12.5 kPa
- •- Fibrosure® (Fibrotest®) performed during screening with a score of = 0.48 and an aspartate aminotransferase (AST)-to-platelet ratio index (APRI) of = 1
- •-Compensated cirrhosis (F4) defined as any one of the following:
- •- Liver biopsy performed prior to Day 1 showing cirrhosis (Metavir stage 4 or equivalent)
- •- Fibroscan® within 12 months of Day 1 showing cirrhosis with result > 12.5 kPa
- •- Fibrosure® (Fibrotest®) performed during screening with a score of > 0.75 and an APRI of > 2 APRI formula: AST ÷ lab upper limit of normal (ULN) for AST × 100 ÷ (platelet count ÷ 100). NOTE: In the absence of a definitive diagnosis of presence or absence of cirrhosis by the above criteria, a liver biopsy or Fibroscan® is required. Liver biopsy results supersede the results obtained by Fibroscan® or Fibrosure®.
- •- Subject is, in the opinion of the investigator, willing and able to comply with the study drug regimen and all other study requirements
排除标准
- •- Female subject is pregnant or breastfeeding
- •-Co-infected with hepatitis B virus (HBV; positive for hepatitis B surface antigen [HBsAg]) and/or human immunodeficiency virus (HIV)
- •-Abuse of alcohol and/or illicit drug use that could interfere with adherence to study requirements as judged by the investigator
- •-Prior exposure to any HCV DAA
- •-Requirement of any prohibited medications, as described in Section 5.8
- •-Use of other investigational drugs within 30 days of dosing or plans to enroll in another clinical trial of an investigational agent while participating in the present study
- •-Subject with known allergy to the study medications or any of their components
- •-History or signs of decompensated liver disease: ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or other clinical signs of portal hypertension or hepatic insufficiency
- •- Cirrhotic and has a Child-Pugh score >6, corresponding to a Child-Pugh Class B or C Note: To calculate the Child-Pugh score, refer to the following website: https://www.mdcalc.com/calc/340/child-pugh-score-cirrhosis-mortality
- •-History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC
- •-Active clinically significant diseases including:
- •-Evidence of history of chronic hepatitis not caused by HCV, including drug-induced hepatitis, hemochromatosis, Wilson’s disease, alpha-1-antitrypsin deficiency, alcoholic liver disease, and autoimmune hepatitis
- •-Cardiac abnormalities/dysfunction that may interfere with subject treatment, assessment, or compliance with the protocol, including unstable angina, unstable congestive heart failure, and unstable arrhythmia
- •-Malignant disease or suspicion or history of malignant disease within previous 5 years (except for adequately treated basal or basosquamous cell carcinoma)
- •-Any medical condition requiring chronic use of systemic corticosteroids or other immunosuppressive drugs (e.g., for organ transplantation or autoimmune conditions). Note: Topical or inhaled corticosteroids are permitted.
- •-Subject with intestinal malabsorption (e.g., structural defects, digestive failure, or enzyme deficiencies, with the exception of lactose intolerance)
- •-Any other clinically significant medical condition that, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results
- •- Clinically significant abnormal ECG at Screening, as determined by the investigator.
- •- Any of the following laboratory parameters at Screening:
- •-Alanine aminotransferase (ALT) or AST > 10 x ULN
- •-Total bilirubin > 3 mg/dL ( > 51.3 µmol/L)
- •-Albumin < 2.8 g/dL ( < 28 g/L)
- •-International Normalized Ratio (INR) > 2.2 unless subject has a stable INR on an anticoagulant
- •-Hemoglobin < 10 g/dL
- •-Hemoglobin A1c (HbA1c) > 8.5%
- •-Platelet count < 50 x 109/L
- •-Estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73 m2 as estimated by the Modification of Diet in Renal Disease (MDRD) formula
- •Note: Retests of Screening laboratory parameters or assessments may be permitted once in certain scenarios with medical monitor approval. Such scenarios may include lab processing error, results inconsistent with subject’s historical values/medical history, or other extenuating circumstances such as a recent or intercurrent illness potential
研究者
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