A Phase IIb Clinical Study to Assess the Pharmacokinetics, Safety, and Efficacy of the Combination Regimen of Elbasvir (EBR)/Grazoprevir (GZR) in Participants Aged 3 to less than 18 Years with Chronic Hepatitis C Infection - The Combination Regimen of EBR/GZR in Pediatric Participants with Chronic Hepatitis C Infection

概览

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注册库

who.int

开始日期

2017年11月2日

结束日期

2020年7月23日

最后更新

5年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

•1\. The participant has HCV RNA (\=1,000 IU/mL in peripheral blood) at the time of screening.
•2\. The participant has documented chronic HCV GT1 or GT4 infection as follows:
•a) positive for anti\-HCV antibody, HCV RNA, or HCV GT1 or GT4 at least 6 months before Day 1; or
•b) positive for anti\-HCV antibody or HCV RNA with a liver biopsy consistent with chronic HCV infection (such as the presence of fibrosis) before Day 1\.
•3\. For participants with GT4, HCV RNA \<800,000 IU/mL at the time of screening.
•4\. For participants with GT1a, no evidence of NS5A RASs detected at screening at positions 28, 30, 31, and/or 93\.
•5\. The participant has liver disease staging assessment as follows:
•a) Absence of cirrhosis (F0 to F3\) defined as any one of the following:
•i. Liver biopsy performed within 24 months of Day 1 showing absence of cirrhosis, or
•ii. FibroScan® performed within 12 months of Day 1 with a result \=12\.5 kPa (only for participants aged 12 years up to 18 years), or

•1\. The participant has evidence of decompensated liver disease manifested by the presence of or history of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy, or other signs or symptoms of advanced liver disease.
•2\. The participant is cirrhotic AND has a Child\-Turcotte\-Pugh score \>6, corresponding to a Child Class B or C.
•3\. The participant is co\-infected with HIV.
•4\. Has evidence of past or present hepatitis B infection (either hepatitis B core antibody \[anti\-HBc] positive and/or hepatitis B surface antigen \[HBsAg] positive) at screening.
•5\. The participant has a history of malignancy \=5 years prior to signing informed consent or is under evaluation for other active or suspected malignancy including HCC.
•6\. A WOCBP is expecting to conceive or donate eggs from Day 1 through at least 14 days after the last dose of study treatment or longer if dictated by local regulations.
•7\. The participant has any of the following conditions:
•a) organ transplants (including hematopoietic stem cell transplants) other than cornea and hair.
•b) poor venous access that precludes routine peripheral blood sampling required for this study.
•c) history of gastric surgery (eg, stapling, bypass) or malabsorption disorders (eg, uncontrolled celiac sprue disease).