EUCTR2019-002086-35-BG进行中（未招募）1 期
A PHASE II, RANDOMISED, ADAPTIVE, OPEN-LABEL PLATFORM TRIAL TO EVALUATE EFFICACY ANDSAFETY OF MULTIPLE COMBINATION THERAPIES IN PARTICIPANTS 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
- 65
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
- •- Participant must be 18 to 65 years of age
- •- Body mass index between 18 and 32 kg/m2 inclusive
- •- Participants with CHB infection (HBsAg [Hepatitis B surface antigen] positive for >= 6 months) who are on established Nucleos[t]ide (NUC) monotherapy for >=12 months, having received the same NUC therapy for >=3 months prior to screening
- •- Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) below the limit of quantification (LLOQ) or < 20 IU/mL for > 6 months prior to screening and confirmed at screening
- •- Alanine transaminase (ALT) <=1.5 x upper limit of normal (ULN) for > 6 months prior to screening, and confirmed at screening
- •- Screening laboratory values within normal range, or judged not clinically significant by the Investigator
- •- Female Participants: Women of non-childbearing potential or women of childbearing potential who agree to remain abstinent or use highly effective contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 6 months after the final dose of study treatment and willing to undergo a urine pregnancy test every 3 months until the end of the study
- •- Male Participants: remain abstinent, refrain from donating sperm or use contraceptive measures such as condom with a pregnant female partner or such as condom plus an additional contraceptive method that together result in failure rate of <1% per year with a female partner of childbearing potential during the treatment period and for at least 6 months after the final dose of 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 65
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Pregnant or lactating women
- •- Co-infection with pathogens such as hepatitis A (HAV), hepatitis C (HCV), hepatitis D (HDV), hepatitis E (HEV), or human immunodeficiency virus (HIV)
- •- History of cirrhosis or current evidence of significant liver fibrosis or cirrhosis, or decompensated liver disease (e.g., ascites, hepatic encephalopathy). Liver biopsy or transient/ Acoustic radiation force impulse/ magnetic resonance elastography result must be obtained within 6 months prior to randomisation
- •- History of or suspicion of Hepatocellular carcinoma
- •- Thyroid disease poorly controlled on prescribed medications or clinically relevant abnormal thyroid function tests at screening, as judged by the Investigator
- •- Clinically significant disease other than CHB that, in the opinion of the Investigator, makes the participant unsuitable for the study
- •- Pre-existing cardiac disease that in the opinion of the Investigator would increase the risk for the participant to take part in the study
- •- History of alcohol abuse and/or drug abuse within one year of randomization.
- •- History of having received (in the last 6 months) or currently receiving any systemic antineoplastic or immunosuppressive or immune modulating treatment for malignant or non-malignant disorders.
- •- Currently taking, or have received within 3 months of Day 1, systemic corticosteroids at a high-dose (e.g., 40 mg prednisolone per day for) > 7 days, or a low-dose (e.g., 20 mg prednisolone per day) for > 14 days.
- •- Electrocardiogram with clinically significant abnormalities
- •- Laboratory parameters at screening
- •Hemoglobin < lower limit of normal (LLN); platelets < LLN; international normalized ratio (INR) > 1.1 x ULN
- •Albumin < 3 g/dL; total bilirubin > ULN (exception: Gilbert’s disease).
- •Positive results for anti-mitochondrial antibodies (AMA > 1:80), antinuclear antibody (ANA > 1:80), anti–smooth muscle antibody (ASMA > 1:40), or anti-thyroperoxidase antibodies (a-TPO >= ULN)
- •White blood cell count < 2500 cells/mm3; neutrophil count < 1500 cells/mm3
- •Glomerular filtration rate < 60 mL/min
- •Positive test for drugs of abuse and/or positive alcohol test at screening. For positive cannabinoids test, the eligibility is at the Investigator’s discretion.
- •- Previous treatment with an investigational agent for HBV within 6 months prior to screening
- •- Unable to comply with any drugs or nutrients listed in prohibited medications and prohibited food sections in the respective treatment arm appendix.
- •- Known hypersensitivity to any excipients of the study drug
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