NCT05461170进行中（未招募）2 期
A Phase 2 Study to Evaluate Efficacy, Safety and Tolerability of VIR-2218 and VIR-3434 in Participants With Chronic Hepatitis D Virus Infection (SOLSTICE)
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
- 95
- 试验地点
- 21
- 主要终点
- Proportion of participants with undetectable HDV RNA (< limit of detection [LOD]) or ≥ 2 log10 decrease in HDV RNA from baseline and alanine aminotransferase (ALT) normalization (ALT < upper limit of normal [ULN]) at Week 24
研究概览
简要总结
This is a phase 2 trial in which participants with chronic hepatitis D virus (HDV) infection will receive VIR-2218 and/or VIR-3434 and be assessed for safety, tolerability, and efficacy
详细描述
Participants may be enrolled into Cohort 1 (1a and 1b) or Cohort 2 (2a, 2b1 or 2b2, 2c), 3, 4, and 5. All participants still receiving VIR-2218 or VIR-3434 monotherapy at the time of implementation of Protocol Amendment 4 will switch to combination therapy at Week 132 (Cohort 2a, 2b1/2b2) or Week 112 (Cohort 3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ages 18 to < 70 years at screening
- •Chronic HDV infection for >/= 6 months
- •On NRTI therapy for at least 12 weeks prior to day 1
- •ALT>ULN and < 5x ULN
- •Non-cirrhotic and CPT-A cirrhotic
排除标准
- •Any clinically significant chronic or acute medical or psychiatric condition that makes the participant unsuitable for participation.
- •History of significant liver disease from non-HBV or non-HDV etiology
- •History of allergic reactions, hypersensitivity, or intolerance to study drug, its metabolites, or excipients.
- •History of anaphylaxis
- •History of immune complex disease
- •History of autoimmune disorder
- •History or evidence of alcohol or drug abuse
- •Prior or concomitant therapy with an immunomodulatory agent, IFN-alpha, cytotoxic or chemotherapeutic agent, or chronic corticosteroids.
- •Anti-HBs >10 mIU/mL at screening
研究组 & 干预措施
Cohort 4 (NRTI)
Placebo Comparator
Participants will receive NRTI for 12 weeks, then assign to Cohort 2c or Cohort 3.
干预措施: NRTI (Drug)
Cohort 5 (VIR-2218)
Experimental
Participants will receive multiple doses of VIR-2218 for 12 weeks, then assign to Cohort 2c.
干预措施: VIR-2218 (Drug)
Cohort 3 (VIR-3434)
Experimental
Participants will receive multiple doses of VIR-3434 for up to 112 weeks, then assign to Cohort 2c.
干预措施: VIR-3434 (Drug)
Cohort 1a (VIR-2218)
Experimental
Participants will receive multiple doses of VIR-2218 for up to 96 weeks total.
干预措施: VIR-2218 (Drug)
Cohort 1b (VIR-3434)
Experimental
Participants will receive multiple doses of VIR-3434 for up to 96 weeks total.
干预措施: VIR-3434 (Drug)
Cohort 2a (VIR-2218)
Experimental
Participants will receive multiple doses of VIR-2218 for up to 132 weeks, then assign to Cohort 2c.
干预措施: VIR-2218 (Drug)
Cohort 2b1 (VIR-3434)
Experimental
Participants will receive multiple doses of VIR-3434 for up to 132 weeks, then assign to Cohort 2c.
干预措施: VIR-3434 (Drug)
Cohort 2b2 (VIR-3434)
Experimental
Participants will receive multiple doses of VIR-3434 for up to 132 weeks, then assign to Cohort 2c.
干预措施: VIR-3434 (Drug)
Cohort 2c (VIR-2218 + VIR-3434)
Experimental
Participants will receive multiple doses of VIR-2218 + VIR-3434 for up to 336 weeks.
干预措施: VIR-2218 (Drug)
Cohort 2c (VIR-2218 + VIR-3434)
Experimental
Participants will receive multiple doses of VIR-2218 + VIR-3434 for up to 336 weeks.
干预措施: VIR-3434 (Drug)
结局指标
主要结局
Proportion of participants with undetectable HDV RNA (< limit of detection [LOD]) or ≥ 2 log10 decrease in HDV RNA from baseline and alanine aminotransferase (ALT) normalization (ALT < upper limit of normal [ULN]) at Week 24
时间窗: Up to 24 Weeks
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
时间窗: Up to 118 Weeks
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
时间窗: Up to 360 Weeks
次要结局
- Change from baseline in Model for End Stage Liver Disease (MELD) score at Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 144, and Week 192(Up to 192 Weeks)
- Proportion of participants with HDV RNA < lower limit of quantitation (LLOQ) at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, and Week 192.(Up to 192 Weeks)
- Change from baseline in Child-Pugh-Turcotte (CPT) score at Week 24, Week 48, Week 72, Week 96, Week 144, and Week 192(Up to 192 Weeks)
- Proportion of participants with undetectable HDV RNA (less than LOD) or greater than/equal to 2 log10 decrease in HDV RNA from baseline and ALT normalization at Week 12, Week 48, Week 72, Week 96, Week 144, and Week 192.(Up to 192 Weeks)
- Proportion of participants with undetectable HDV RNA (less than LOD) or greater than/equal to 2 log10 decrease in HDV RNA from baseline at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, and Week 192.(Up to 192 Weeks)
- Proportion of participants with undetectable HDV RNA (less than LOD) at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, and Week 192.(Up to 192 Weeks)
- Change from baseline in HDV RNA at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, and Week 192.(Up to 192 Weeks)
- Proportion of participants with ALT normalization at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, and Week 192.(Up to 192 Weeks)
- Change from baseline in liver fibrosis at Week 48, Week 96, Week 144, and Week 192(Up to 192 Weeks.)
- Incidence of anti-drug antibodies (ADA) and titers of ADA to VIR-3434 at specified study visits up to Week 192 (for cohorts with VIR3434)(Up to 192 Weeks)
- Proportion of participants with undetectable HDV RNA (less than LOD) or greater than/equal to 2 log10 decrease in HDV RNA from baseline and ALT normalization at Week 12, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.(Up to 336 Weeks)
- Proportion of participants with undetectable HDV RNA (less than LOD) or greater than/equal to 2 log10 decrease in HDV RNA from baseline at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.(Up to 336 Weeks)
- Proportion of participants with undetectable HDV RNA (less than LOD) at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.(Up to 336 Weeks)
- Proportion of participants with HDV RNA < lower limit of quantitation (LLOQ) at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.(Up to 336 Weeks)
- Change from baseline in HDV RNA at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.(Up to 336 Weeks)
- Proportion of participants with ALT normalization at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.(Up to 336 Weeks)
- Incidence of anti-drug antibodies (ADA) and titers of ADA to VIR-3434 at specified study visits up to Week 336 (for cohorts with VIR3434)(Up to 336 Weeks)
- Change from baseline in liver fibrosis at Week 48, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.(Up to 336 Weeks.)
- Change from baseline in Model for End Stage Liver Disease (MELD) score at Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.(Up to 336 Weeks)
- Change from baseline in Child-Pugh-Turcotte (CPT) score at Week 24, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.(Up to 336 Weeks)
研究者
研究点 (21)
Loading locations...
相似试验
已完成
2 期
A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D VirusHepatitis D, ChronicNCT04535544Janssen Research & Development, LLC52
Unknown
4 期
Pegylated Interferon Alfa-2b Plus Ribavirin in Chronic Hepatitis B and DeltaChronic Hepatitis BChronic Hepatitis DNCT00117533National Taiwan University Hospital20
进行中（未招募）
2 期
Study of VIR-2218, VIR-3434, and/or PEG-IFNα in Subjects With Chronic Hepatitis B Virus InfectionHepatitis B, ChronicNCT04856085Vir Biotechnology, Inc.244
已完成
2 期
Study of VIR-2218 With or Without Pegylated Interferon Alpha-2a for Treatment of Chronic Hepatitis B Virus InfectionChronic Hepatitis BNCT04412863Vir Biotechnology, Inc.84
已完成
2 期
A Study to Evaluate Pegylated Interferon Lambda Monotherapy in Patients With Chronic Hepatitis Delta Virus InfectionHepatitis D, ChronicNCT02765802EIT Pharma, Inc.33
相关资讯
Vir Biotechnology Advances Hepatitis D Combo Therapy to Phase 3 Trials• Vir Biotechnology plans to launch Phase 3 trials (ECLIPSE program) in 2025 for its tobevibart and elebsiran combination therapy for chronic hepatitis D.
• Phase 2 SOLSTICE study data showed the combo suppressed hepatitis delta virus and normalized liver damage markers in patients with hepatitis D.
• The FDA granted fast track designation to the combination treatment for chronic hepatitis D, and the EMA issued a positive opinion on orphan drug designation.
• The Phase 3 program includes two trials evaluating the combo in patients with and without cirrhosis, and a head-to-head Phase 2b trial against bulevirtide.last yearVir Biotechnology Receives Positive EU Opinion for Orphan Drug Designation of Tobevibart and Elebsiran in Chronic Hepatitis Delta• The EMA's COMP issued a positive opinion for orphan drug designation of tobevibart and elebsiran for chronic hepatitis delta (CHD).
• The decision was based on encouraging preliminary data from the Phase 2 SOLSTICE trial, with 24-week data presented at The Liver Meeting.
• Orphan drug designation provides incentives, including scientific advice, fee reductions, and 10 years of market exclusivity in the EU.
• The FDA previously granted fast track designation for tobevibart and elebsiran, highlighting growing recognition of their potential in CHD.last yearVir Biotechnology Receives Positive EU Opinion for Hepatitis Delta Therapy• Vir Biotechnology's tobevibart and elebsiran receive positive opinion for orphan drug designation from the EMA for chronic hepatitis delta (CHD).
• The decision follows encouraging preliminary data from the Phase 2 SOLSTICE trial, with full data to be presented at AASLD The Liver Meeting.
• This regulatory milestone could grant Vir Biotechnology 10 years of market exclusivity in the EU upon approval.
• CHD is a severe liver disease with limited treatment options, making this designation a significant step toward addressing an unmet medical need.last yearVir Biotechnology to Present Latest Hepatitis Delta and B Data at EASL Congress 2024Vir Biotechnology, Inc. announced that three abstracts featuring new data from its chronic hepatitis delta and chronic hepatitis B programs will be presented at the EASL Congress 2024. The presentations will include findings from the Phase 2 SOLSTICE trial, focusing on the efficacy and safety of tobevibart and elebsiran.2 years ago