EUCTR2017-001110-29-BE进行中（未招募）1 期
A Phase 2a, Randomized, Partially-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Pharmacokinetics of 24 Weeks of Treatment With Multiple Doses of JNJ-56136379 as Monotherapy and in Combination With a Nucleos(t)ide Analog in Subjects With Chronic Hepatitis B Virus Infection
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 220
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
- •Subjects must be 18 (or older legal age of consent as per local requirements) to 70 years of age, inclusive.
- •Subjects must have CHB infection documented by:
- •- Serum HBsAg-positive at screening and at least 6 months prior to screening.
- •- Serum IgM anti-HBc antibody negative at screening.
- •In subjects currently not being treated (Treatment Arms 1-2-3 and 6-7-8):
- •- Subjects must not be receiving any CHB treatment at screening, ie,
- •? Have never received treatment with HBV antiviral medicines, including NAs or IFN products, OR
- •? Have not been on treatment with HBV antiviral medicines, including NAs or IFN products within 6 months prior to baseline (first intake of study drugs), AND
- •- Subjects must be HBeAg-positive and have HBV DNA =20,000 IU/mL, OR be HBeAg-negative and have HBV DNA =2,000 IU/mL at screening, AND
- •- Subjects must have HBsAg >250 IU/mL at screening, AND
- •- Subjects must have ALT > ULN and =5 x ULN at screening, determined in the central laboratory.
- •Note: If subjects were treated with investigational anti-HBV agents more than 6 months before screening, the sponsor should be contacted to discuss the case. Subjects who have received treatment with a CAM for more than 4 weeks any time prior to screening are excluded.
- •In virologically suppressed subjects (Treatment Arms 4-5 and 9-10):
- •- Subjects must be virologically suppressed by current NA treatment (ETV or TDF) as defined by HBV DNA <60 IU/mL at screening and at least 6 months prior to screening, AND
- •- Subjects must be on the same NA treatment (ETV or TDF) and the same dose for =12 months prior to screening, AND
- •- Subjects must have HBsAg >250 IU/mL at screening, AND
- •- Subjects must have ALT =2x ULN at screening
- •Note: If subjects were treated with investigational anti-HBV agents more than 6 months before screening, the sponsor should be contacted to discuss the case. Subjects who have received treatment with a CAM for more than 4 weeks any time prior to screening are excluded.
- •Subjects must have:
- •- A liver biopsy result classified as Metavir F0-F2 within 1 year prior to screening or at the time of screening, OR
- •- FibroScan™ liver stiffness measurement <8.0 kPa within 6 months prior to screening or at the time of screening.
- •Female subjects of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin) at screening.
- •Female subjects must be:
- •- Not of childbearing potential
- •- Of childbearing potential and
- •o Practicing a highly effective, preferably user-independent method of contraception (failure rate of <1% per year when used consistently and correctly) and agrees to remain on a highly effective method while receiving study treatment and until 90 days after last dose of JNJ-56136379.
- •A female subject must agree not to donate eggs (ova, oocytes) during the study until at least 90 days after the last dose of JNJ-56136379.
- •A male subject must agree to wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the study until at least 90 days after the last dose of JNJ-56136379.
- •A male subject must agree not to donate sperm during the study and for at least 90 days after receiving the last dose of JNJ-56136379.
- •Subject 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.
- •Subject must sign a separate ICF i
排除标准
- •Subjects who test positive for anti-HBs antibodies.
- •Subjects with current hepatitis A virus infection (confirmed by hepatitis A antibody IgM), HCV infection (confirmed by HCV antibody), HDV infection (confirmed by HDV antibody), hepatitis E virus infection (confirmed by hepatitis E antibody IgM), or HIV-1 or HIV-2 infection (confirmed by antibodies) at screening. Evidence of other active infection (bacterial, viral, fungal, including acute tuberculosis) deemed clinically relevant by the investigator that would interfere with study conduct or its interpretation will also lead to exclusion.
- •Subjects with any evidence of hepatic decompensation at any time point prior to or at the time of screening:
- •- Direct bilirubin >1.2x ULN, or
- •- International normalized ratio >1.5x ULN, or
- •- Serum albumin < lower limit of normal (LLN), or
- •- Documented history or current evidence of variceal bleeding, ascites, or hepatic encephalopathy.
- •Subjects with any evidence of liver disease of non-HBV etiology. This includes but is not limited to hepatitis virus infections mentioned above, drug- or alcohol-related liver disease, autoimmune hepatitis, hemochromatosis, Wilson’s disease, Gilbert’s syndrome, a-1 antitrypsin deficiency, primary biliary cirrhosis, primary sclerosing cholangitis, or any other non-HBV liver disease considered clinically significant by the investigator.
- •Subjects who have signs of hepatocellular carcinoma (HCC) on an abdominal ultrasound performed within 2 months prior to screening or at the time of screening. In case of suspicious findings on conventional ultrasound, subject may still be eligible if HCC has been ruled out by a more specific imaging procedure (contrast enhanced ultrasound, CT or MRI).
研究者
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