NCT07762027尚未招募2 期
A Phase 2, Multicenter, Open Label, Parallel-Group Study of the Safety, Pharmacokinetics, and Efficacy of ABI-6250 in Participants With Chronic Hepatitis D Virus Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 22
- 主要终点
- Proportion of subjects with adverse events (AEs), premature treatment discontinuation and abnormal laboratory results.
研究概览
简要总结
This study is designed to assess safety, pharmacokinetics, and efficacy ABI-6250 in participants with Chronic Hepatitis D Virus 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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has a body mass index ≥18.0 and <35.0 kg/m2 at Screening
- •Other than HBV and HDV infection, the participant is in good health (as determined by the Investigator) based on medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory results.
- •Participant agrees to comply with protocol-specified contraception requirements.
排除标准
- •Participant has a current coinfection with acute hepatitis A virus (HAV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
- •Participant has a history of any significant food or drug-related allergic reactions such as anaphylaxis, Stevens-Johnson syndrome, or urticaria.
- •Participant has been treated for HDV infection in the past 6 months prior to Day
- •Participant took part in another clinical trial of a drug or device (other than for HDV infection) whereby the last study drug/device administration is within 30 days or 5 half-lives, whichever is longer, prior to Day 1.
研究组 & 干预措施
Treatment Arm 4
Experimental
干预措施: ABI-6250 (Drug)
Treatment Arm 1
Experimental
干预措施: ABI-6250 (Drug)
Treatment Arm 2
Experimental
干预措施: ABI-6250 (Drug)
Treatment Arm 3
Experimental
干预措施: ABI-6250 (Drug)
结局指标
主要结局
Proportion of subjects with adverse events (AEs), premature treatment discontinuation and abnormal laboratory results.
时间窗: Through study completion, an average of 1.5 years.
Evaluating the change from baseline in HDV RNA & ALT levels
时间窗: Through study completion, an average of 1.5 years.
次要结局
- Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs and abnormal laboratory results.(Through study completion, an average of 1.5 years.)
- Proportion of participants with undetectable HDV RNA or ≥2 log10 IU/mL reduction in HDV RNA(Through study completion, an average of 1.5 years.)
- In participants with abnormal baseline ALT, the proportion of participants with normal ALT(Through study completion, an average of 1.5 years.)
- Change from baseline in log10 HDV RNA(Through study completion, an average of 1.5 years.)
- In participants with abnormal baseline ALT, the change from baseline in ALT(Through study completion, an average of 1.5 years.)
- In participants with abnormal baseline ALT, proportion of participants with normal ALT(Through study completion, an average of 1.5 years.)
- To characterize the PK of ABI-6250 in plasma in participants with cHDV(Through study completion, an average of 1.5 years.)
研究者
研究点 (22)
Loading locations...
相似试验
进行中（未招募）
1 期
AB-3028, a Programmable Circuit T Cell Therapy in Patients With Castration Resistant Prostate Cancer (CRPC)NCT07285694Arsenal Biosciences, Inc.190
尚未招募
1 期
Phase Ib/II Study to Evaluate the Safety and Efficacy of IBI363 in Combination With Chemotherapy as Second-Line Therapy for Unresectable Locally Advanced or Metastatic Pancreatic CancerNCT07342725Ruijin Hospital48
尚未招募
1 期
Alpha-0261 Tablets for Moderate-to-Severe Ulcerative ColitisUlcerative Colitis (UC)NCT07744646The First Affiliated Hospital of Anhui Medical University10
招募中
2 期
A Proof-of-Concept Study of IBI3002 in Patients With Moderate to Severe Atopic DermatitisAtopic DermatitisNCT07399067Innovent Biologics (Suzhou) Co. Ltd.120
招募中
3 期
A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia AHemophilia ANCT07416526Hoffmann-La Roche126