NL-OMON50813撤回2 期
A PHASE II, RANDOMISED, ADAPTIVE, OPEN-LABEL PLATFORM TRIAL TO EVALUATE EFFICACY AND SAFETY OF MULTIPLE COMBINATION THERAPIES IN PARTICIPANTS WITH CHRONIC HEPATITIS B - COMBINATION THERAPIES FOR CHB
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Covance
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Informed Consent
- •1. Able and willing to provide written informed consent and to comply with the
- •protocol according to International Council for Harmonization (ICH) and local
- •regulations.
- •2. Participants must be between 18 and 65 years of age, inclusive, at the time
- •signing the informed consent.
- •3. Body mass index between 18 and 32 kg/m2 inclusive.
- •Type of Participants and Disease Characteristics
- •4. Participants with CHB infection (HBsAg positive for **6 months) who are on
- •(entecavir or tenofovir alafenamide/disoproxil fumarate) monotherapy
- •for *12 months, having received the same NUC therapy for** 3 months prior to
- •5. HBV DNA below the LLOQ or < 20 IU/mL for > 6 months prior to screening and
- •confirmed at screening.
- •6. Alanine transaminase (ALT) **1.5 x upper limit of normal (ULN) for > 6
- •months prior
- •to screening, and confirmed at screening
- •7. Screening laboratory values (hematology, chemistry, urinalysis) within normal
- •range, or judged not clinically significant by the Investigator and Medical
- •8. Male and female participants:
- •The contraception and abstinence requirements are intended to prevent exposure
- •an embryo to the study treatment. The reliability of sexual abstinence for
- •eligibility needs to be evaluated in relation to the duration of the clinical
- •the preferred and usual lifestyle of the participant. Periodic abstinence (e.g.,
- •calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal
- •not acceptable methods of preventing fetal/embryonic drug exposure.
- •The following contraception requirements must be followed unless otherwise
- •in the respective appendix of each treatment arm.
- •a) Female Participants:
- •A female participant is eligible to participate if she is not pregnant (see
- •Appendix 5),
- •not breastfeeding, and at least one of the following conditions applies:
- •* Woman of non-childbearing potential (WONCBP), as defined in Appendix 5.
- •* Woman of childbearing potential (WOCBP), who:
- •* Agrees to remain abstinent (refrain from heterosexual intercourse) 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
- •study treatment. Examples of contraceptive methods with a failure rate of <1%
- •per year include bilateral tubal occlusion, male sterilization, established
- •use of hormonal contraceptives that inhibit ovulation, hormone-releasing
- •intrauterine devices, and copper intrauterine devices (see Appendix 5).
- •* Has a negative pregnancy test at screening (Day -14 to -7). In addition, WOCBP
- •must be willing to undergo a urine pregnancy test every 3 months until the end
- •b) Male Participants:
- •During the treatment period and for at least 6 months after the final dose of
- •treatment, agree to:
- •* Remain abstinent (refrain from heterosexual intercourse) or use
- •contraceptive measures such as a condom plus an additional contraceptive
- •method that together result in a failure rate of <1% per year, with a partner
- •who is a woman of childbearing potential (WOCBP, as defined in Section 1
- •in Appendix 5).
- 另有 2 项未显示
排除标准
- •Medical Conditions
- •1. Pregnant (positive pregnancy test) or lactating women.
- •2. Co-infection with other pathogens such as hepatitis A (HAV), hepatitis C
- •hepatitis D (HDV), hepatitis E (HEV), or human immunodeficiency virus (HIV).
- •3. History of cirrhosis or current evidence of significant liver fibrosis or
- •cirrhosis (F3 or
- •above on liver biopsy, *7.4 kPa on transient elastography, >1.32 m/s on acoustic
- •radiation force impulse [ARFI] elastography, or >3.13 kPa on magnetic resonance
- •elastography), or decompensated liver disease (e.g., ascites, hepatic
- •encephalopathy). Liver biopsy or transient elastography/ARFI/MR result must be
- •obtained within 6 months prior to randomization.
- •4. History of or suspicion of hepatocellular carcinoma (HCC) (e.g, elevated *-
- •fetoprotein
- •[AFP] levels, suggestive lesions on abdominal ultrasound or other imaging,
- •5. Thyroid disease poorly controlled on prescribed medications or clinically
- •abnormal thyroid function tests (thyroid-stimulating hormone [TSH], free
- •triiodothyronine [FT3], free thyroxin [FT4]) at screening, as judged by the
- •Investigator and Medical Monitor.
- •6. Clinically significant disease other than CHB that, in the opinion of the
- •Investigator,
- •makes the participant unsuitable for the study.
- •7. Pre-existing cardiac disease that in the opinion of the investigator would
- •the risk for the patient to participate to the study.
- •8. History of alcohol abuse and/or drug abuse within one year of randomization.
- •9. History of having received (in the last 6 months) or currently receiving any
- •systemic antineoplastic
- •(including radiation) or immunosuppressive (including biologic
- •immunosuppressors) or immune modulating treatment (including non-biological oral
- •immune modulating drugs; e.g., methotrexate > 25 mg per week,
- •azathioprine > 3.0 mg/kg/day or 6-mercaptopurine > 1.5 mg/kg/day) for malignant
- •non-malignant disorders.
- •10. 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.,
- •prednisolone per day) for > 14 days.
- •Diagnostic Assessments
- •11. Electrocardiogram (ECG) with clinically significant abnormalities,
- •including QTcF
- •interval (QT corrected using Fridericia*s formula) *450 msec for males and *470
- •msec for females at screening.
- •12. Laboratory parameters at screening:
- •a) Hemoglobin <12 g/dL (females) or <13 g/dL (males); platelets normal (LLN); international normalized ratio (INR) >1.1.
- •b) Albumin <3 g/dL; total bilirubin >ULN (exception: Gilbert*s disease).
- •c) Positive results for anti-mitochondrial antibodies (AMA >1:80), antinuclear
- •antibody (ANA >1:80), anti*smooth muscle antibody (ASMA >1:40), or
- •antithyroperoxidase
- •antibodies (a-TPO >10).
- •d) White blood cell count <2500 cells/mm3; neutrophil count <1500 cells/mm3
- •(<1000 cells/mm3 if considered a physiological variant in a participant of
- •e) Glomerular filtration rate (GFR; using Modification of Diet in Renal Disease
- 另有 7 项未显示
研究者
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