NCT06497504进行中（未招募）2 期
A Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Assess the Efficacy and Safety of Treatment With Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection on Antiretroviral Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 153
- 试验地点
- 51
- 主要终点
- Percentage of participants achieving hepatitis B virus (HBV) virologic response at 36 weeks after scheduled end of study treatment in absence of rescue medication
研究概览
简要总结
This study will evaluate the efficacy and safety of bepirovirsen compared to placebo in participants with human immunodeficiency virus (HIV)/hepatitis B virus (HBV) co-infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This will be a double-blind study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented chronic hepatitis B virus (HBV) infection and documented human immunodeficiency virus (HIV)-1 infection greater than equal to (>=) 12 months prior to Screening.
- •Must be on uninterrupted antiretroviral therapy (ART) containing at least tenofovir disoproxil (TDF) or tenofovir alafenamide (TAF) plus lamivudine (3TC) or emtricitabine (FTC) for greater than (>)12 months, with no planned changes to the stable regimen over the duration of the study.
- •o Switch in ART is permitted >=6 months prior to Screening for reasons not related to loss of HIV or HBV control (e.g., change in formulary, tolerability, side effects).
- •Documented evidence of at least 2 plasma HIV-1 ribonucleic acid (RNA) measurements less than (<) 50 copies per milliliter (copies/mL) are required in the 12 months prior to Screening: 1 within 6 to 12 months prior to Screening and 1 within 6 months prior to Screening.
- •Plasma or serum HBV deoxyribonucleic acid (DNA) concentration must be adequately suppressed, defined as plasma or serum HBV DNA <90 international units per milliliter (IU/mL).
- •Plasma or serum HBsAg concentration >100 IU/mL and <=3000 IU/mL.
- •Plasma HIV-1 RNA concentration must be undetectable, defined as plasma HIV 1 RNA <50 copies/mL.
- •Cluster of differentiation 4 (CD4) count >=350 cells per cubic millimeter (cells/mm^3).
- •Alanine aminotransferase (ALT) <=2 times upper limit of normal (ULN).
排除标准
- •History of or suspected liver cirrhosis and/or evidence of cirrhosis.
- •Diagnosed or suspected hepatocellular carcinoma (HCC).
- •History of extrahepatic disorders possibly related to HBV immune conditions (e.g., nephrotic syndrome, any type of glomerulonephritis, polyarteritis nodosa, cryoglobulinemia, uncontrolled hypertension).
- •Coinfection with:
- •Hepatitis C virus (HCV) with positive HCV antibody and detectable HCV RNA at Screening.
- •I. HCV treatment should have completed >12 months prior to Screening.
- •Hepatitis D virus (HDV) defined as positive or equivocal HDV antibody regardless of HDV RNA level.
- •Clinically significant abnormalities, aside from HIV-1 infection and chronic HBV infection in medical history (e.g., moderate severe liver disease other than chronic HBV/HIV, acute coronary syndrome within 6 months of Screening, major surgery within 3 months of Screening, significant/unstable cardiac disease, uncontrolled diabetes, bleeding diathesis coagulopathy) or clinically significant physical examination findings.
- •Untreated syphilis infection (positive rapid plasma reagin [RPR] at Screening without clear documentation of treatment) are excluded unless they complete treatment during the Screening period and 7 days prior to randomization.
- •History of malignancy within the past 5 years with the exception of specific cancers that are cured by surgical resection (e.g., skin cancer). Participants under evaluation for possible malignancy are not eligible.
- •History of vasculitis or presence of symptoms and signs of potential vasculitis (e.g., vasculitic rash, skin ulceration, repeated blood detected in urine without identified cause), current or history of an autoimmune condition or history/presence of other diseases that may be associated with vasculitis condition (e.g., systemic lupus erythematosus, rheumatoid arthritis, relapsing polychondritis, mononeuritis multiplex).
- •Participants who in the investigator's judgment, have a significant risk of suicide or self-harm.
- •Alcohol or drug abuse/dependence
- •Currently taking, or took within 3 months of Screening, any immunosuppressing drugs (e.g., prednisone), other than a short course of therapy (<=2 weeks) or topical/inhaled steroid use.
- •Participants to whom immunosuppressive treatment, including therapeutic doses of steroids, is contraindicated should not be considered for enrolment in the study.
- •Currently taking, or has taken within 12 months of Screening, any interferon containing therapy.
- •Participants requiring anti coagulation therapies (e.g., warfarin, Factor Xa inhibitors) or anti platelet agents (including but not limited to clopidogrel or aspirin) unless treatment can safely be discontinued throughout duration of study intervention, by the discretion of the investigator. Occasional use is permitted.
- •Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.
- •Prior treatment with any oligonucleotide or small interfering ribonucleic acid (siRNA) within 12 months prior to the first dosing day.
- •Prior treatment with bepirovirsen.
研究组 & 干预措施
Participants receiving Placebo
Placebo Comparator
Participants will receive placebo.
干预措施: Placebo (Drug)
Participants receiving Bepirovirsen
Experimental
Participants will receive bepirovirsen.
干预措施: Bepirovirsen (Drug)
结局指标
主要结局
Percentage of participants achieving hepatitis B virus (HBV) virologic response at 36 weeks after scheduled end of study treatment in absence of rescue medication
时间窗: At study week 60
HBV virologic response defined as HBV surface antigen (HBsAg) not detected and HBV deoxyribonucleic acid (DNA) less than (\<) lower limit of quantification (LLOQ).
次要结局
- Percentage of participants achieving HBV virologic response at the scheduled end of study treatment in absence of rescue medication(At study week 24)
研究者
研究点 (51)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety of Tx360® Transnasal Sphenopalatine Ganglion Block in the Treatment of Chronic MigraineHeadache, MigraineNCT03337620Tian Medical Inc.174
已完成
1 期
CMX001 in Post-transplant Patients With BK Virus ViruriaViruriaNCT00793598Chimerix29
已完成
3 期
Brivaracetam as add-on Treatment of Unverricht-Lundborg Disease in Adolescents and AdultsUnverricht-Lundborg DiseaseNCT00357669UCB Pharma SA50
已完成
2 期
Efficacy of SENS-111 in Patients Suffering From Acute Unilateral VestibulopathyAcute Unilateral Vestibulopathy (AUV)NCT03110458Sensorion107
已完成
3 期
Efficacy and Safety of Tolvaptan in the Treatment of Cardiac-Induced Edema in Patients With Heart FailureCardiac-induced EdemaNCT01618448Taiwan Otsuka Pharm. Co., Ltd85