EUCTR2019-004902-85-GB进行中（未招募）1 期
A Phase 2a, Multicenter, Single-Blind, Placebo-Controlled, Multiple Cohort Study Evaluating ABI-H2158-Containing Regimens in Chronic Hepatitis B Infection
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
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
- •1. Willing and able to provide informed consent
- •2. Male or female between the ages 18 and 65 years (inclusive)
- •3. Female subjects must be non-pregnant and have a negative serum pregnancy test at Screening and a negative urine pregnancy test predose on Day 1.
- •4. Chronic hepatitis B infection, defined as HBV infection for =6 months documented, for example, by at least two measurements of HBsAg positivity and/or detectable HBV DNA =6 months apart (inclusive of Screening). For subjects without clear documentation of CHB, serum immunoglobulin M (IgM) antibody to the HBV core-related antigen (HBcrAb) must be negative at Screening to exclude acute HBV infection.
- •5. Body mass index (BMI) 18 to 36 kg/m2 and a minimum body weight of 45 kg (inclusive)
- •6. HBV DNA =2 × 105 IU/mL
- •7. HBeAg =500 IU/mL at Screening
- •8. HBsAg >1000 IU/mL at Screening
- •9. Lack of cirrhosis or advanced liver disease as documented by the following:
- •o Liver biopsy results of METAVIR F0-F2 (absence of bridging fibrosis or cirrhosis) within 1 year of Screening
- •o Fasting 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 ultrasonographer with expertise in evaluation of liver fibrosis) within 6 months of Screening indicating lack of cirrhosis or advanced liver disease (F0-F2 or equivalent).
- •10. Agreement to comply with protocol-specified contraceptive requirements.
- •11. Agreement to abstain 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 from screening until end of the study
- •12. In good general health, except for CHB
- •13. Have the ability to take oral medication and, in the opinion of the Investigator, be willing to adhere to study treatment
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 72
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •1. Prior treatment for CHB; specifically
- •a. lamivudine, telbivudine or adefovir (any duration)
- •b. NrtI treatment for > 4 weeks
- •c. HBV core inhibitors (any duration)
- •d. Previous treatment with an investigational agent for HBV infection
- •2. Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis E virus (HEV), or hepatitis D virus (HDV)
- •3. Females who are lactating, or wish to become pregnant during the course of the study
- •4. History or evidence of advanced liver disease or hepatic decompensation (including jaundice, ascites, portal hypertension, gastrointestinal bleeding esophageal varices, hepatic encephalopathy,) at any time prior to, or at the time of Screening.
- •5. History of persistent alcohol 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
- •6. Clinically significant cardiac or pulmonary disease, chronic or recurrent renal or urinary tract disease, liver disease other than CHB, 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, ongoing infection 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 study participation.
- •7. History of hepatocellular carcinoma (HCC)
- •8. 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
- •9. Poorly controlled or unstable hypertension; or sustained systolic blood pressure (BP) = 160 mmHg or <90 mmHg, or diastolic BP >95 mmHg or <50 mmHg at Screening
- •10. History or presence of electrocardiogram (ECG) abnormalities deemed clinically significant as described in the protocol.
- •11. History of hypersensitivity or idiosyncratic reaction to any components or excipients of the investigational drug or PBO formulation
- •12. History of any significant food or drug-related allergic reactions such as, anaphylaxis, Stevens-Johnson syndrome, or urticaria
- •13. The following exclusionary laboratory results at Screening and Baseline visit:
- •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’s syndrome; subjects with Gilbert’s syndrome are eligible for study participation if the direct bilirubin is within the normal range
- •d. Direct bilirubin >1.2 × ULN
- •e. ALT >5 × ULN
- •f. Serum alpha fetoprotein (AFP) =100 ng/mL. If AFP at Screening is > ULN but <100 ng/mL, the subject is eligible if a hepatic imaging study prior to initiation of study drug reveals no lesions indicative of possible HCC.
- •g. International Normalized Ratio (INR) >1.5 × ULN
- •h. 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) >6.5%
- •j. Any other laboratory abnormality deemed clinically significant by the Sponsor or the Investigator
- •14. Subjects receiving prohibited concomitant medications, grapefruit juice, herbal or over-the counter medications (Section 6.4.1) within 7 days or 5 half-lives (if known), whichever is longer, p
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