NL-OMON51913招募中3 期
ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC) - ASSURE
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 15
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 99（—）
入选标准
- •1. Must have given written informed consent (signed and dated)
- •2. Participated in a prior PBC study with seladelpar (including CB8025-21629,
- •CB8025-31735, or CB8025-31731), current PBC studies (CB8025-32048 or
- •CB8025-21838), or completed a future PBC study with seladelpar that allows
- •rollover into CB8025-31731-RE, and meet eligibility criteria for the current
- •3. 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 subjects 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 subjects with a study drug
- •interruption greater than 4 weeks prior to Day 1 of this study and for subjects
- •who participated in CB8025-21838 irrespective of seladelpar interruption.
- •1. Treatment-related adverse event (AE) leading to study drug discontinuation
- •in a previous PBC study with seladelpar
- •2. A medical condition, other than PBC, that in the Investigator*s opinion
- •would preclude full participation in the study or confound its results (e.g.,
- •cancer, any active infection)
- •3. AST or ALT above 3 × the upper limit of normal (ULN)
- •4. Total bilirubin above 2 × ULN
- •5. MELD score >= 12. For subjects 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.
- •6. Evidence of advanced PBC as defined by the Rotterdam criteria: albumin below
- •1× the lower limit of normal AND total bilirubin above 1 × ULN)
- •7. Estimated glomerular filtration rate <= 45 mL/min/1.73 m2 (calculated by
- •Modification of Diet in Renal Disease formula)
- •8. Auto-immune hepatitis
- •9. Primary sclerosing cholangitis
- •10. Known history of alpha-1-antitrypsin deficiency
- •11. Known history of chronic viral hepatitis
- •12. For females, pregnancy or breast-feeding
- •13. Use of colchicine, methotrexate, azathioprine, or long-term use of systemic
- •steroids (e.g. prednisone, prednisolone, budesonide) (>2 weeks) within 2 months
- •prior to Screening. See the concomitant medication section for additional
- •medications that may be excluded.
- •14. Current use of fibrates or use of fibrates within 3 months prior to
- •15. Current use of obeticholic acid or use of obeticholic acid within 3 months
- •prior to Screening
- •16. Use of an experimental or unapproved treatment for PBC within 3 months
- •prior to Screening
- •17. 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
- •18. Treatment with any other investigational therapy or medical device within
- •30 days or within 5 half-lives, whatever is longer, prior to Screening
- •19. Any other condition(s) that would compromise the safety of the subject or
- •compromise the quality of the clinical study, as judged by the Investigator
- •20. Immunosuppressant therapies (e.g., cyclosporine, tacrolimus, anti TNF or
- •other immunosuppressive biologics)
- •21. Other medications that effect liver or GI functions such as absorption of
- •medications or roux-en-y gastric bypass procedure may be prohibited and should
- •be discussed with the medical monitor on a case-by-case basis
- •22. Positive for:
- •a. Hepatitis B, defined as the presence of hepatitis B surface antigen
- •b. Hepatitis C, defined as the presence of hepatitis C virus ribonucleic acid
- •c. Human immunodeficiency virus (HIV) antibody
- •23. Active COVID-19 infection during Screening.
研究者
相似试验
进行中（未招募）
1 期
A study to evaluate the safety and tolerability of seladelpar in subjects with primary biliary cholangitisMedDRA version: 21.0Level: LLTClassification code: 10036680Term: Primary biliary cirrhosis Class: 10019805Primary Biliary CholangitisCTIS2024-511753-22-00Cymabay Therapeutics Inc.339
进行中（未招募）
1 期
A study to evaluate the safety and tolerability of seladelpar in subjectswith primary biliary cholangitisMedDRA version: 21.0Level: LLTClassification code 10036680Term: Primary biliary cirrhosisSystem Organ Class: 100000004871Primary Biliary CholangitisEUCTR2020-005198-29-PLCymaBay Therapeutics, Inc.500
进行中（未招募）
1 期
A study to evaluate the safety and tolerability of seladelpar in subjectswith primary biliary cholangitisMedDRA version: 21.0Level: LLTClassification code 10036680Term: Primary biliary cirrhosisSystem Organ Class: 100000004871Primary Biliary CholangitisEUCTR2020-005198-29-BECymaBay Therapeutics, Inc.500
进行中（未招募）
1 期
A study to evaluate the safety and tolerability of seladelpar in subjectswith primary biliary cholangitisMedDRA version: 21.0Level: LLTClassification code 10036680Term: Primary biliary cirrhosisSystem Organ Class: 100000004871Primary Biliary CholangitisEUCTR2020-005198-29-NLCymaBay Therapeutics, Inc.500
进行中（未招募）
1 期
A study to evaluate the safety and tolerability of seladelpar in subjectswith primary biliary cholangitisMedDRA version: 21.0Level: LLTClassification code 10036680Term: Primary biliary cirrhosisSystem Organ Class: 100000004871Primary Biliary CholangitisEUCTR2020-005198-29-CZCymaBay Therapeutics, Inc.385