EUCTR2020-001249-37-IT进行中（未招募）1 期
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study with Deferred Active Treatment to Investigate the Efficacy, Safety, and Pharmacokinetics of JNJ-73763989 + Nucleos(t)ide Analog in Participants Co-infected with Hepatitis B and Hepatitis D Virus - REEF-D
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
- 145
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. male or female (according to their reproductive organs and functions assigned by chromosomal complement).
- •2. 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 65 years of age, inclusive.
- •3. medically stable on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening. Any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator.
- •4. must have:
- •- chronic hepatitis B infection either HBeAg positive or HBeAg negative and either receiving NA treatment or no NA treatment. Chronic HBV infection documented by serum HBsAg positivity at screening. In addition, chronicity must be documented by serum HBsAg positivity at least 6 months prior to screening or alternative markers of chronicity (HBeAg positivity or HBV DNA positivity at least 6 months prior to screening)
- •- chronic HDV infection documented by positive HDV antibodies or HDV RNA at screening. In addition, chronicity must be documented by positive HDV antibodies or HDV RNA at least 3 months prior to screening.
- •5. must have HDV RNA values at screening =1,000 IU/mL.
- •6. must have ALT levels <10x ULN at screening.
- •7. Participants must have a BMI (weight in kg divided by the square of height in meters) between 18.0 and 35.0 kg/m2, extremes included.
- •8. must have presence or absence of compensated cirrhosis based on:
- •a. No cirrhosis: LSM <12.5 kPa by VCTE (FibroScan) within 6 months prior to screening or at the time of screening or liver biopsy within 1 year prior to screening, OR
- •b. Cirrhosis: LSM =12.5 kPa by VCTE (FibroScan) within 6 months prior to screening or at the time of screening or liver biopsy within 1 year prior to screening; and a Child-Pugh score A.
- •Note: If FibroScan is not available, other radiologic liver staging modalities (eg, acoustic radiation force impulse) might be used at screening if standard practice at the site or if otherwise validated and agreed with the sponsor.
- •Note: Conventional imaging procedures (eg, conventional liver ultrasound, computed tomography [CT] or magnetic resonance imaging [MRI]) and serum marker panels are not allowed.
- •9. must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
- •10. must sign a separate ICF if he or she agrees to provide an optional DNA sample for research (where local regulations permit). Refusal to give consent for the optional DNA research sample does not exclude a participant from participation in the study.
- •11. a woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urine pregnancy test on Day 1 before the first dose of study intervention.
- •12. a woman must be (as defined in Section 10.8, Appendix 8, Contraceptive and Barrier Guidance)
- •a. Not of childbearing potential
- •b. Of childbearing potential and practicing a highly effective, preferably user independent method of contraception (failure rate of <1% per year when used consistently and correctly) for at least 30 days prior to screening and agrees to remain on a highly effective method while receiving study intervention and until 90 days after last dose - the end of relevant systemic exposure. Examples of highly effective methods of contracep
排除标准
- •1. Participants with evidence of hepatitis A virus infection (hepatitis A antibody immunoglobulin M [IgM]), hepatitis C virus (HCV) infection (HCV antibody), or hepatitis E virus (HEV) infection (hepatitis E antibody IgM), or human immunodeficiency virus type 1 (HIV-1) or HIV type 2 (HIV-2) infection (confirmed by antibodies) at screening.
- •- Participants with a positive HCV antibody test can be enrolled if they have negative HCV RNA at screening and documented negative HCV RNA at least 6 months prior to screening.
- •- Participants with a positive IgM antibody test for HEV infection may be enrolled after discussion with the sponsor if an active HEV infection can be ruled out by documentation of negative anti-HEV IgG.
- •2. any of the following laboratory abnormalities within 12 months prior to screening or at time of screening:
- •a. Total bilirubin >1.7x ULN,
- •b. Direct bilirubin >1.4x ULN,
- •c. Prothrombin time >1.3x ULN,
- •d. Serum albumin <3.2 g/dL.
- •3. history or evidence of clinical signs/symptoms of hepatic decompensation including but not limited to: portal hypertension, ascites, hepatic encephalopathy.
- •Note: Participants with uncomplicated splenomegaly may be enrolled after consultation with the sponsor.
- •4. Child-Pugh score >6.
- •5. evidence of liver disease of non-HDV or non-HBV etiology. This includes but is not limited to hepatitis virus infections mentioned in exclusion criterion 1, drug- or alcohol-related liver disease, autoimmune hepatitis, hemochromatosis, Wilson’s disease, a-1 antitrypsin deficiency, primary biliary cholangitis, primary sclerosing cholangitis, Gilbert’s syndrome (mild cases are allowed, see exclusion criterion 2a), or any other non-HBV/HDV or non-viral liver disease considered clinically significant by the investigator.
- •6. signs of HCC or clinically relevant renal abnormalities on an abdominal ultrasound performed within 6 months prior to screening or at the time of screening. In case of suspicious findings on conventional ultrasound, the participant may still be eligible if HCC or clinically relevant renal abnormalities has been ruled out by a more specific imaging procedure (contrast enhanced ultrasound, CT, or MRI).
- •7. one or more of the following laboratory abnormalities at screening as defined by the Division of Acquired Immunodeficiency Syndrome (DAIDS) Toxicity Grading Scale:
- •a. Estimated glomerular filtration rate (eGFR) =grade 3 (ie, <60 mL/min/1.73 m2) at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula,
- •b. Total amylase =grade 3,
- •c. Lipase elevation =grade 3,
- •d. Hemoglobin =10.9 g/dL (males), =10.4 g/dL (females),
- •e. Platelet count =100,000/dL,
- •f. Alpha-fetoprotein (AFP) >100 ng/mL,
- •g. Any other laboratory abnormality considered to be clinically significant by the investigator.
- •Note: Participants with AFP >ULN (but =100 ng/mL) may be eligible if HCC can be ruled out based on a sensitive imaging study (eg, enhanced ultrasound, CT, or MRI) during screening.
- •8. hemoglobin A1c >8% at screening.
- •9. history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence).
- •10. abnormal sinus rhythm (heart rate <45 or >100 beats per minute [bpm]); QT interval corrected for heart rate according to Fridericia (QTcF) >450 ms for male participants and >470 ms for female participants; Q
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