- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07639996
Natural Course and Molecular Basis of Alpha 1- Antitrypsin Deficiency-associated Liver Disease.
- To define the course of AATD-associated liver disease.
To use the obtained samples for biomedical research which includes:
- Search for serum-based disease biomarkers and the associated molecular pathways.
- Multi-omic spatial analysis of human AATD-LD.
연구 개요
상세 설명
AATD is one of the most common, potentially lethal genetic conditions and results from mutations in alpha-1 antitrypsin (AAT), an abundant serine protease inhibitor (SERPIN) produced primarily in hepatocytes. The majority of severe AATD cases result from a homozygous PiZ mutation termed PiZZ that leads to a rapid polymerization of the mutated protein and its retention in the endoplasmic reticulum (ER) of hepatocytes. The consecutive lack of AAT in circulation increases proteolytic digestion of lung tissue and predisposes to chronic obstructive pulmonary disease and lung emphysema. The hepatic AAT misfolding confers a proteotoxic stress and may lead to both pediatric and adult liver disease (pAATD-LD/aAATD-LD). The former becomes apparent as neonatal jaundice and constitutes one of the most common causes of pediatric liver transplantation while the latter emerges mostly at >40 years of age as significant liver fibrosis and occurs more frequently in subjects with metabolic risk factors such as obesity and diabetes mellitus.
Much less is known about pAATD-LD that is considered a more cholestatic condition with less obvious AAT accumulation. Moreover, the exact relationship between AAT accumulation and development of AATD-LD remains unclear.
A major obstacle when studying AATD-LD is the lack of a suitable experimental model system. While transgenic animals overexpressing PiZ have been widely used, they have several disadvantages such as presence of multiple PiZ copies as well as inability to reproduce pAATD-LD. To circumvent that, analyses of human specimen as well as human induced pluripotent stem cells (iPSC) derived hepatocyte like cells (HLCs) are essential. Therefore, our research aims to obtain further insights into the process of AAT accumulation as well as to delineate the mechanistic differences between pediatric and adult AATD-LD.
연구 유형
등록 (추정된)
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
- Adult patients (≥18 years) with genetically confirmed alpha-1 antitrypsin deficiency (Pi*ZZ genotype).
- Availability of longitudinal clinical follow-up data (minimum 5 years) within the AATD consortium.
- At least one documented liver assessment including liver stiffness measurement (LSM) and serum-based fibrosis markers.
- Availability of stored serum samples for proteomic analysis.
- For translational analyses: availability of liver tissue samples (pediatric or adult) and/or induced pluripotent stem cell (iPSC)-derived hepatocyte-like cells.
설명
Inclusion Criteria:
- Adult patients (≥18 years) with genetically confirmed alpha-1 antitrypsin deficiency (Pi*ZZ genotype).
- Availability of longitudinal clinical follow-up data (minimum 5 years) within the AATD consortium.
- At least one documented liver assessment including liver stiffness measurement (LSM) and serum-based fibrosis markers.
- Availability of stored serum samples for proteomic analysis.
- For translational analyses: availability of liver tissue samples (pediatric or adult) and/or induced pluripotent stem cell (iPSC)-derived hepatocyte-like cells.
Exclusion Criteria:
- Presence of other chronic liver diseases (e.g., viral hepatitis, autoimmune hepatitis) that may confound fibrosis assessment.
- History of liver transplantation prior to study inclusion.
- Incomplete clinical, laboratory, or follow-up data.
- Poor-quality or insufficient biological samples for proteomic or molecular analyses.
- Patients lost to follow-up or with unreliable longitudinal data
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Search for serum-based disease biomarkers and the associated molecular pathways
기간: Eight months of performing serum proteomics to identify biomarkers that reflect liver disease severity and predict poor outcomes
|
Eight months of performing serum proteomics to identify biomarkers that reflect liver disease severity and predict poor outcomes
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Multi-omic spatial analysis of human AATD-LD.
기간: Eight months of conduction of spatial multi-omic analyses comparing pediatric and adult liver tissues. This will include proteomic and transcriptomic mapping to understand how AAT accumulation and ductular reactions differ between the two forms.
|
Eight months of conduction of spatial multi-omic analyses comparing pediatric and adult liver tissues. This will include proteomic and transcriptomic mapping to understand how AAT accumulation and ductular reactions differ between the two forms.
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Townsend SA, Edgar RG, Ellis PR, Kantas D, Newsome PN, Turner AM. Systematic review: the natural history of alpha-1 antitrypsin deficiency, and associated liver disease. Aliment Pharmacol Ther. 2018 Apr;47(7):877-885. doi: 10.1111/apt.14537. Epub 2018 Feb 15.
- Tafaleng EN, Chakraborty S, Han B, Hale P, Wu W, Soto-Gutierrez A, Feghali-Bostwick CA, Wilson AA, Kotton DN, Nagaya M, Strom SC, Roy-Chowdhury J, Stolz DB, Perlmutter DH, Fox IJ. Induced pluripotent stem cells model personalized variations in liver disease resulting from alpha1-antitrypsin deficiency. Hepatology. 2015 Jul;62(1):147-57. doi: 10.1002/hep.27753. Epub 2015 Apr 13.
- Strnad P, McElvaney NG, Lomas DA. Alpha1-Antitrypsin Deficiency. N Engl J Med. 2020 Apr 9;382(15):1443-1455. doi: 10.1056/NEJMra1910234. No abstract available.
- Ruiz M, Lacaille F, Schrader C, Pons M, Socha P, Krag A, Sturm E, Bouchecareilh M, Strnad P. Pediatric and Adult Liver Disease in Alpha-1 Antitrypsin Deficiency. Semin Liver Dis. 2023 Aug;43(3):258-266. doi: 10.1055/a-2122-7674. Epub 2023 Jul 4.
- Patel D, McAllister SL, Teckman JH. Alpha-1 antitrypsin deficiency liver disease. Transl Gastroenterol Hepatol. 2021 Apr 5;6:23. doi: 10.21037/tgh.2020.02.23. eCollection 2021.
- Ncube A, Bewersdorf L, Spitzhorn LS, Loerch C, Bohndorf M, Graffmann N, May L, Amzou S, Fromme M, Wruck W, Strnad P, Adjaye J. Generation of two Alpha-I antitrypsin deficiency patient-derived induced pluripotent stem cell lines ISRM-AATD-iPSC-1 (HHUUKDi011-A) and ISRM-AATD-iPSC-2 (HHUUKDi012-A). Stem Cell Res. 2023 Sep;71:103171. doi: 10.1016/j.scr.2023.103171. Epub 2023 Jul 23.
- Kaserman JE, Hurley K, Dodge M, Villacorta-Martin C, Vedaie M, Jean JC, Liberti DC, James MF, Higgins MI, Lee NJ, Washko GR, San Jose Estepar R, Teckman J, Kotton DN, Wilson AA. A Highly Phenotyped Open Access Repository of Alpha-1 Antitrypsin Deficiency Pluripotent Stem Cells. Stem Cell Reports. 2020 Jul 14;15(1):242-255. doi: 10.1016/j.stemcr.2020.06.006. Epub 2020 Jul 2.
- Hamesch K, Mandorfer M, Pereira VM, Moeller LS, Pons M, Dolman GE, Reichert MC, Schneider CV, Woditsch V, Voss J, Lindhauer C, Fromme M, Spivak I, Guldiken N, Zhou B, Arslanow A, Schaefer B, Zoller H, Aigner E, Reiberger T, Wetzel M, Siegmund B, Simoes C, Gaspar R, Maia L, Costa D, Bento-Miranda M, van Helden J, Yagmur E, Bzdok D, Stolk J, Gleiber W, Knipel V, Windisch W, Mahadeva R, Bals R, Koczulla R, Barrecheguren M, Miravitlles M, Janciauskiene S, Stickel F, Lammert F, Liberal R, Genesca J, Griffiths WJ, Trauner M, Krag A, Trautwein C, Strnad P; European Alpha1-Liver Study Group. Liver Fibrosis and Metabolic Alterations in Adults With alpha-1-antitrypsin Deficiency Caused by the Pi*ZZ Mutation. Gastroenterology. 2019 Sep;157(3):705-719.e18. doi: 10.1053/j.gastro.2019.05.013. Epub 2019 May 20.
- Greene CM, Marciniak SJ, Teckman J, Ferrarotti I, Brantly ML, Lomas DA, Stoller JK, McElvaney NG. alpha1-Antitrypsin deficiency. Nat Rev Dis Primers. 2016 Jul 28;2:16051. doi: 10.1038/nrdp.2016.51.
- Fromme M, Schneider CV, Trautwein C, Brunetti-Pierri N, Strnad P. Alpha-1 antitrypsin deficiency: A re-surfacing adult liver disorder. J Hepatol. 2022 Apr;76(4):946-958. doi: 10.1016/j.jhep.2021.11.022. Epub 2021 Nov 27.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Alpha 1 antitrypsin deficiency
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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