EUCTR2018-002042-36-GB进行中（未招募）1 期
A Phase 2a, Multi-center, Double-blind, Placebo-controlled Study Evaluating ABI-H0731 + Entecavir vs Entecavir Alone for the Treatment of Viremic, HBeAg-positive Patients with Chronic Hepatitis B
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Body mass index (BMI) 18 to 36 kg/m2 and a minimum body weight of 45 kg (inclusive)
- •- Agreement to adhere to Lifestyle Considerations (including abstaining from alcohol abuse [defined as alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol)] and the use of illicit substances, herbal or other substances, or unnecessary over-the-counter medications; see Protocol Section 5.4) throughout study duration
- •- In good general health except for chronic HBV infection (defined as HBV infection for at least 6 months documented by at least two repeated HBsAg positivity and/or history of detectable viral load documented at least two times =6 months apart), and serum IgM anti-HBV core-related antibody negative at screening
- •- HBV viral load =2×105 IU/mL
- •- HBeAg-positive at screening
- •- HBsAg >1000 IU/mL at screening
- •- Liver biopsy results of
- •oMetavir F0-F2 (absence of bridging fibrosis or cirrhosis) within 1 year of screening
- •oFasting FibroScan =8 kPa within 3 months of screening (including screening visit) or other Sponsor-approved hepatic imaging study (hepatic magnetic resonance imaging [MRI], or hepatic ultrasound by a ultrasongrapher with expertise in evaluation of liver fibrosis) within 6 months of screening indicating lack of cirrhosis or advanced liver disease (F0-F2 or equivalent).
- •Subjects with an ambiguous non-invasive result, eg, a fasting FibroScan >8 kPa and =10 kPa are excluded unless a biopsy within the 12 months before first visit confirms the absence of bridging fibrosis and cirrhosis. Subjects with a FibroScan >10 kPa are excluded
- •- Have the ability to take oral medication and be willing to adhere to the ABI-H0731-202 regimen in the opinion of the Investigator
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 24
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •- Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis E virus (HEV), or hepatitis D virus (HDV)
- •- History or evidence of hepatic decompensation (including gastrointestinal bleeding or esophageal varices) at any time prior to or at time of screening
- •- Subject is febrile (temperature >37.5°C) at screening
- •- Clinically significant cardiac or pulmonary disease, chronic or recurrent renal or urinary tract disease, liver disease other than HBV, endocrine disorder, autoimmune disorder, diabetes mellitus requiring treatment with insulin or hypoglycemic agents, neuromuscular, musculoskeletal, or mucocutaneous conditions requiring frequent treatment, seizure disorders requiring treatment, or other medical conditions requiring frequent medical management or pharmacologic or surgical treatment that in the opinion of the Investigator or the Sponsor makes the subject unsuitable for the study
- •- Any prior treatment with lamivudine or telbivudine, previous treatment with an investigational agent for HBV other than ABI-H0731; or any other SOC treatment for >4 weeks
- •- Participation in another clinical trial of a drug or device whereby the last investigational drug/device administration is within 60 days or five half-lives prior to the first study drug administration, whichever is longer
- •- History of persistent ethanol abuse (alcohol consumption exceeding 2 standard drinks per day on average [1 standard drink = 10 grams of alcohol]) or illicit drug abuse within 3 years before screening
- •- Females who are lactating or pregnant or wish to become pregnant
- •- History of hepatocellular carcinoma (HCC)
- •- A history of malignancy other than HCC unless the subject’s malignancy has been in complete remission off chemotherapy and without additional medical or surgical interventions during the 3 years before screening
- •- Exclusionary laboratory results
- •a.Platelet count <100,000/mm3
- •b.Albumin < lower limit of normal (LLN)
- •c.Total bilirubin >1.2×upper limit of normal (ULN) unless known Gilbert syndrome; subjects with Gilbert syndrome are eligible if direct bilirubin is within normal limits
- •d.Direct bilirubin >1.2×ULN
- •e.ALT >10×ULN at screening
- •f.Serum alpha fetoprotein (AFP) =100 ng/mL. If AFP at screening is >ULN but <100 ng/mL, subject is eligible if a hepatic imaging study prior to initiation of study drug reveals no lesions suspicious of possible HCC
- •g.Prothrombin time: International Normalized Ratio (INR) >1.5×ULN
- •Glomerular filtration rate (GFR) <60 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation [Levey 2009]
- •i.Serum hemoglobin A1c (HbA1c) >8%
- •j.Any other laboratory abnormality deemed clinically significant by the Sponsor or the Investigator
研究者
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