EUCTR2020-005198-29-CZ进行中（未招募）1 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
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 385
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
- 性别
- All
入选标准
- •1. Must have given informed consent (signed and dated)
- •2. Participated in a prior PBC study with seladelpar (e.g., 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 study.
- •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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 330
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 55
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 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 × 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 Screening
- •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 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
- •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
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