- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
- 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.
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Search for serum-based disease biomarkers and the associated molecular pathways
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Multi-omic spatial analysis of human AATD-LD.
Periodo de tiempo: 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.
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Enfermedades Genéticas Congénitas
- Enfermedades de las vías respiratorias
- Enfermedades del Sistema Digestivo
- Enfermedades pulmonares
- Enfermedades del HIGADO
- Enfisema subcutáneo
- Enfisema
- Enfermedades y anomalías congénitas, hereditarias y neonatales
- Condiciones Patológicas, Signos y Síntomas
- deficiencia de alfa 1-antitripsina
Otros números de identificación del estudio
- Alpha 1 antitrypsin deficiency
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Deficiencia de alfa 1-antitripsina (AATD)
-
Tessera Therapeutics, Inc.ReclutamientoDeficiencia de alfa-1 antitripsina (AATD)Estados Unidos, Australia
-
University of ParmaChiesi Farmaceutici S.p.A.TerminadoDeficiencia de alfa-1 antitripsina (AATD)Italia
-
RenJi HospitalActivo, no reclutandoDeficiencia de alfa-1 antitripsina (AATD)Porcelana
-
Muğla Sıtkı Koçman UniversityPROGENIKA BIOPHARMA, A GRIFOLS CompanyReclutamientoDeficiencia de alfa 1-antitripsina (AATD)Turquía (Türkiye)
-
Intellia TherapeuticsRetiradoDeficiencia de alfa-1 antitripsina | Enfermedad pulmonar | Enfermedad pulmonar | AATD | Enfermedad pulmonar asociada a deficiencia de alfa-1 antitripsinaNueva Zelanda
-
Inhibrx, Inc.TerminadoDeficiencia de alfa-1 antitripsina | AATDEstados Unidos, Nueva Zelanda, Reino Unido
-
Wave Life Sciences Ltd.TerminadoDeficiencia de alfa-1 antitripsina (AATD)Reino Unido
-
University of PittsburghNational Heart, Lung, and Blood Institute (NHLBI)TerminadoDeficiencia de alfa 1 antitripsina | AATDEstados Unidos
-
University of FloridaTerminadoDeficiencia de alfa-1 antitripsina | Fibrosis hepática | AATD | Deficiencia de AATEstados Unidos
-
Grifols Therapeutics LLCTerminadoEnfisema | Deficiencia de alfa 1-antitripsina (AATD)Estados Unidos