EUCTR2017-001110-29-DE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 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
- •1. Subjects must be 18 (or older legal age of consent as per local requirements) to 70 years of age, inclusive.
- •2. Subjects must have a body mass index (weight in kg divided by the square of height in meters) of 18.0 to 35.0 kg/m2, extremes included.
- •3. Criterion modified per Amendment 3
- •3.1 Subjects must have CHB infection documented by:
- •- Serum HBsAg-positive at screening and serum HBsAg- or HBV DNA positive at least 6 months prior to screening.
- •- Serum IgM anti-HBc antibody negative at screening.
- •4. In subjects currently not being treated (Treatment Arms 1-2-3 and 6-
- •- Subjects must not be receiving any CHB treatment at screening, ie,
- •o Have never received treatment with HBV antiviral medicines, including NAs or IFN products, OR
- •o 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,
- •- 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.
- •5. Criterion modified per Amendment 3
- •5.1 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.
- •Note: The current NA treatment can either be a branded product or a locally approved generic alternative (including different salt forms [eg,
- •tenofovir maleate or succinate]). During the study, subjects will receive branded ETV (Baraclude®) or TDF (Viread®) treatment, as applicable.
- •6. 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.
- •Note: Conventional imaging procedures (eg, conventional liver ultrasound, computed tomography [CT] or magnetic resonance imaging
- •[MRI]) and serum marker panels are not allowed to rule out severe fibrosis or cirrhosis.
- •7. Female subjects of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin) at
- •8. 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 af
排除标准
- •1. Subjects who test positive for anti-HBs antibodies.
- •2. Criterion modified per Amendment 3
- •2.1 Subjects with current hepatitis A virus infection (confirmed by hepatitis A antibody IgM), 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:
- •subjects with a history of or current HCV infection (confirmed by HCV antibody). 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.
- •3. 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.
- •4. 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.
- •5. 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).
- •Additional exclusion criteria are listed in section 4.2 of the protocol.
研究者
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