EUCTR2017-001110-29-GB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
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
- 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
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 6-7-8):
- •- 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 cir
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
相似试验
进行中（未招募）
1 期
A 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 InfectioEUCTR2017-001110-29-DEJanssen Sciences Ireland UC220
进行中（未招募）
1 期
A 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 InfectioChronic Hepatitis B Virus InfectionMedDRA version: 20.1Level: PTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestationsEUCTR2017-001110-29-ESJanssen Sciences Ireland UC232
进行中（未招募）
1 期
A 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 InfectioChronic Hepatitis B Virus InfectionMedDRA version: 20.1Level: PTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestationsEUCTR2017-001110-29-ITJanssen Sciences Ireland Unlimited Company220
进行中（未招募）
1 期
A Study to Assess the Efficacy, Safety, and Pharmacokinetics of 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 InfectioEUCTR2017-001110-29-PLJanssen Sciences Ireland UC220
进行中（未招募）
1 期
A 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 InfectioEUCTR2017-001110-29-BEJanssen Sciences Ireland UC220