NCT07040319招募中1 期
Phase I/II Study of the Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir Initiated in Pregnancy in Women With Hepatitis C With and Without HIV
National Institute of Allergy and Infectious Diseases (NIAID)19 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年6月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 19
- 主要终点
- Geometric mean AUC0-24h
研究概览
简要总结
This is a Phase I/II, multi-site, open-label, single arm study to describe the pharmacokinetics (PK) and safety of glecaprevir/pibrentasvir (GLE/PIB) initiated during pregnancy in women with hepatitis C virus (HCV) infection (acute or chronic) with or without HIV and to evaluate safety for their infants through 10 weeks postpartum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Of legal age or circumstance to provide independent informed consent as determined by site standard operating procedures (SOPs) and consistent with institutional review board/ethics committee (IRB/EC) policies and procedures
- •Willing and able to provide written informed consent for their own and their infant's study participation
- •At entry, 16-45 years of age (inclusive)
- •At entry, gestational age of 14-32 weeks, defined as greater than 13 weeks plus six days and less than or equal to 32 completed weeks gestation, as determined by the site investigator based on best obstetric estimate
- •At screening and at study entry, no evidence of multiple gestation, fetal anomalies, or intrauterine fetal growth restriction, as determined by the site investigator based on ultrasound
- •At screening, detectable HCV RNA test result based on testing of a specimen collected within 30 days prior to entry
- •At screening, negative test results for hepatitis B surface antigen based on testing of a specimen collected within 30 days prior to entry
- •At screening (i.e., from specimens collected within 30 days prior to entry), has normal, grade 1, grade 2, or grade 3 results for the following
- •Aspartate aminotransferase (AST) (<10.0 x ULN)
- •Alanine aminotransferase (ALT) (<10.0 x ULN)
- •At screening (i.e., from specimens collected within 30 days prior to entry), has normal, grade 1, or grade 2 results for the following
- •Hemoglobin (≥8.5 g/dL)
- •Creatinine (≤1.8 x ULN)
- •At screening (i.e., from specimens collected within 30 days prior to entry), has normal or grade 1 results for the following
- •International normalized ratio (INR) (<1.5 x ULN)
- •Platelet count (≥100,000 cells/mm3)
- •Total bilirubin (<1.6 x ULN)
- •HIV status determined based on testing meeting the requirements specified in protocol
- •For pregnant participants living with HIV: has a suppressed HIV viral load (HIV-1 RNA below the limit of quantification of the assay) on an ARV regimen for at least 30 consecutive days prior to entry that does not include efavirenz, etravirine, cobicistat, or any protease inhibitor (e.g., atazanavir, darunavir, lopinavir, ritonavir), as determined by the site investigator based on available medical records
- •At entry, expects to remain in the geographic area of the study site during pregnancy and for 10 weeks postpartum (or for 20 weeks post-entry, depending on gestational age at entry), as determined by the site investigator based on pregnant participant report
排除标准
- •Any previous treatment for hepatitis C, including HCV DAAs or interferon-based treatment
- •High risk of preterm delivery, defined as either of the following:
- •History of spontaneous preterm delivery at less than 34 weeks, as determined by the site investigator based on pregnant participant report and available medical records, or
- •Shortened cervix less than 20 mm if noted on ultrasound during the current pregnancy, as determined by the site investigator based on available medical records
- •Receipt of any prohibited medication, within 14 days prior to entry, as determined by the site investigator based on pregnant participant report and available medical records
- •Any of the following liver-related conditions:
- •Clinical diagnosis of acute hepatitis not otherwise attributable to hepatitis C with AST or ALT ≥2.5 x ULN
- •Evidence of decompensated cirrhosis including history of or present variceal hemorrhage, ascites, spontaneous bacterial peritonitis, hepatic encephalopathy, hepatocellular carcinoma, hepatorenal syndrome, or hepatopulmonary syndrome
- •Has any other documented or suspected clinically significant medical condition or any other condition that, in the opinion of the site investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives
研究组 & 干预措施
GLE/PIB
Experimental
Pregnant participants will take three (3) GLE/PIB fixed-dose combination tablets orally once daily with food for eight weeks
干预措施: Glecaprevir/pibrentasvir (Drug)
结局指标
主要结局
Geometric mean AUC0-24h
时间窗: At weeks 3 & 6
Area under the curve from start of dose to 24 hours post dose
Geometric mean Cmax
时间窗: At weeks 3 & 6
Peak concentration from start of dose to 24 hours post dose
Geometric mean C24h
时间窗: At weeks 3 & 6
Concentration at 24 hours post dose
Percentage of pregnant/ postpartum participants who experience a grade 3 or higher adverse event assessed as related to study drug
时间窗: Initiation of treatment to a) completion of treatment and b) latter of 10 weeks post-partum or 20 weeks post treatment initiation
Percentage of pregnant participants who experience a serious adverse event assessed as related to study drug
时间窗: Initiation of treatment to a) completion of treatment and b) latter of 10 weeks post-partum or 20 weeks post treatment initiation
次要结局
- Percentage of infants with a serious adverse events assessed as related to study drug(From birth through 10 weeks of age)
- Percentage of pregnant/postpartum participants with sustained virologic response (SVR12)(12 weeks after planned treatment completion)
- Percentage of pregnant participants with spontaneous abortions or miscarriage(At birth/delivery)
- Percentage of pregnant participants with stillbirths(At birth/delivery)
- Percentage of infants small for gestational age(At birth/delivery)
- Percentage of infants with low birth weight(At birth/delivery)
- Percentage of pre-term births(At birth/delivery)
- Percentage of pregnancies with occurrence of any of the following adverse pregnancy events(At birth/delivery)
- Percentage of infants with a congenital abnormality(At birth/delivery)
- Percentage of infants with a grade 5 adverse event(From birth through 10 weeks of age)
- Percentage of infants with Grade 3 or higher adverse event assessed as related to study drug(From birth through 10 weeks of age)
- Percentage of occurrence of any of the following in infants: grade 5 adverse event within 28 days of birth, grade 3 or higher adverse event assessed as related to study drug, or severe adverse event assessed as related to study drug(From birth through 10 weeks of age)
- Median weight of infants(At birth and 10 weeks of age)
- Median length of infants(At birth and 10 weeks of age)
- Median head circumference of infants(At birth and 10 weeks of age)
- Percentage of pregnant/postpartum participants with sustained virologic response (SVR12)(12 weeks after planned treatment completion)
- Percentage of pregnant participants with spontaneous abortions or miscarriage(At birth/delivery)
- Percentage of pregnant participants with stillbirths(At birth/delivery)
- Percentage of infants small for gestational age(At birth/delivery)
- Percentage of infants with low birth weight(At birth/delivery)
- Percentage of pre-term births(At birth/delivery)
- Percentage of pregnancies with occurrence of any of the following adverse pregnancy events(At birth/delivery)
- Percentage of infants with a congenital abnormality(At birth/delivery)
- Percentage of infants with a grade 5 adverse event(From birth through 10 weeks of age)
- Percentage of infants with Grade 3 or higher adverse event assessed as related to study drug(From birth through 10 weeks of age)
- Percentage of infants with a serious adverse events assessed as related to study drug(From birth through 10 weeks of age)
- Percentage of occurrence of any of the following in infants: grade 5 adverse event within 28 days of birth, grade 3 or higher adverse event assessed as related to study drug, or severe adverse event assessed as related to study drug(From birth through 10 weeks of age)
- Median weight of infants(At birth and 10 weeks of age)
- Median length of infants(At birth and 10 weeks of age)
- Median head circumference of infants(At birth and 10 weeks of age)
- Percentage of infants with quantifiable hepatitis C RNA(At 10 or more weeks of age)
研究者
研究点 (19)
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