NCT03301506进行中（未招募）3 期
ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 340
- 试验地点
- 217
- 主要终点
- Treatment emergent adverse events (TEAEs) (National Cancer Institute {NCI} Common Terminology Criteria for Adverse Events {CTCAE} Version 5.0), biochemistry and hematology results
研究概览
简要总结
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)
详细描述
Primary:
To evaluate the long-term safety and tolerability of seladelpar
Secondary:
- To evaluate the long-term efficacy of seladelpar
- To evaluate the effect of seladelpar on patient-reported outcomes (pruritus)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have given written informed consent (signed and dated)
- •Participated in a PBC study with seladelpar
- •Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male individuals who are sexually active with female partners of reproductive potential must use barrier contraception and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose
排除标准
- •Exclusion criteria are only applicable for individuals with a seladelpar interruption greater than 4 weeks prior to Day 1 of this study and for individuals who participated in CB8025-21838 irrespective of seladelpar interruption.
- •Treatment-related adverse event (AE) leading to study drug discontinuation in a previous PBC study with seladelpar
- •A medical condition, other than PBC, that in the Investigator's opinion would preclude full participation in the study or confound its results (eg, cancer, any active infection)
- •AST or ALT above 3 × the upper limit of normal (ULN)
- •Total bilirubin above 2 × ULN
- •MELD score ≥
- •For individuals on anticoagulation medication, evaluation of the baseline INR, in concert with any current dose adjustments in anti-coagulant medications, will be taken into account when calculating this score. This will be done in consultation with the medical monitor.
- •Evidence of advanced PBC as defined by the Rotterdam criteria: albumin below 1× the lower limit of normal (LLN) AND total bilirubin above 1 × ULN)
- •eGFR ≤45 mL/min/1.73 m2 (calculated by MDRD formula)
- •Auto-immune hepatitis
- •Primary sclerosing cholangitis
- •Known history of alpha-1-antitrypsin deficiency
- •Known history of chronic viral hepatitis
- •For females, pregnancy or breast-feeding
- •Use of colchicine, methotrexate, azathioprine, or long-term use of systemic steroids (eg prednisone, prednisolone, budesonide) (>2 weeks) within 2 months prior to Screening
- •Current use of fibrates or use of fibrates within 3 months prior to Screening
- •Current use of obeticholic acid or use of obeticholic acid within 3 months prior to Screening
- •Use of an experimental or unapproved treatment for PBC within 3 months prior to Screening
- •History of malignancy diagnosed or treated, actively or within 2 years, or active evaluation for malignancy; localized treatment of squamous or non-invasive basal cell skin cancers and cervical carcinoma in-situ is allowed if appropriately treated prior to Screening
- •Treatment with any other investigational therapy or medical device within 30 days or within 5 half-lives, whatever is longer, prior to Screening
- •Any other condition(s) that would compromise the safety of the individual or compromise the quality of the clinical study, as judged by the Investigator
- •Immunosuppressant therapies (eg, cyclosporine, tacrolimus, anti-TNF or other immunosuppressive biologics)
- •Other medications that effect liver or GI functions such as absorption of medications or the roux-en-y gastric bypass procedure may be prohibited and should be discussed with the medical monitor on a case-by-case basis
- •Positive for:
- •Hepatitis B, defined as the presence of hepatitis B surface antigen
- •Hepatitis C, defined as the presence of hepatitis C virus ribonucleic acid (RNA)
- •Human immunodeficiency virus (HIV) antibody
- •Active COVID-19 infection during screening
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Seladelpar 5 mg Capsules
Experimental
干预措施: Seladelpar 5 mg Capsule (Drug)
Seladelpar 10 mg Capsule
Experimental
干预措施: Seladelpar 10 mg Capsule (Drug)
结局指标
主要结局
Treatment emergent adverse events (TEAEs) (National Cancer Institute {NCI} Common Terminology Criteria for Adverse Events {CTCAE} Version 5.0), biochemistry and hematology results
时间窗: Through study completion, up to 60 Months
次要结局
- Ascites(60 Months)
- Laboratory Value: Gamma-glutamyl Transferase (GGT)(Through study completion, up to 60 Months)
- Death(60 Months)
- Hospitalization for variceal bleeding(60 Months)
- Hospitalization for hepatic encephalopathy(60 Months)
- Normalization of ALP(60 Months)
- Laboratory Value: Bilirubin - Unconjugated Bilirubin(Through study completion, up to 60 Months)
- Laboratory Value: Serum Alkaline Phosphatase (ALP)(Through study completion, up to 60 Months)
- Laboratory Value: Alanine Aminotransferase (ALT)(Through study completion, up to 60 Months)
- Laboratory Value: Bilirubin - Total Bilirubin(Through study completion, up to 60 Months)
- Response on composite endpoint(60 Months)
- Change in MELD(60 Months)
- Hospitalization for spontaneous bacterial peritonitis(60 Months)
- Laboratory Value: Aspartate Aminotransferase (AST)(Through study completion, up to 60 Months)
- Liver transplantation(60 Months)
- Laboratory Value: Bilirubin - Conjugated Bilirubin(Through study completion, up to 60 Months)
研究者
研究点 (217)
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相关资讯
Livdelzi Demonstrates Sustained Efficacy and Long-Term Safety in Primary Biliary Cholangitis Treatment- After 2.5 years of Livdelzi (seladelpar) treatment, 81% of adults with primary biliary cholangitis (PBC) showed meaningful reductions in liver damage markers in the Phase 3 ASSURE trial.
- Livdelzi significantly reduced blood levels of alkaline phosphatase (ALP), a key liver damage marker, with 41% of patients achieving normalization of ALP levels.
- Data from the RESPONSE trial showed that Livdelzi led to statistically significant improvements in itching and markers of cholestasis, with a favorable safety profile over five years.
- These findings support Livdelzi as a promising second-line treatment option for PBC patients unresponsive or intolerant to ursodeoxycholic acid (UDCA).last yearGilead's Livdelzi Shows Sustained Efficacy and Long-Term Safety in Primary Biliary Cholangitis- Interim analysis of the Phase 3 ASSURE study reveals that 81% of PBC participants achieved a durable biochemical response with Livdelzi by month 30.
- Notably, 41% of participants experienced normalization of alkaline phosphatase (ALP) levels, a critical marker of liver function, with Livdelzi treatment.
- Livdelzi reduced pruritus severity in PBC participants, leading to near resolution of itch in 27% of those with moderate to severe itch.
- The long-term safety profile of Livdelzi remains robust, with no treatment-related serious adverse events reported throughout the study duration.last year