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NCT01148550: MITOHEP

Longitudinal Study of Mitochondrial Hepatopathies

Suspended Last updated 15 October 2025
What this trial tests

trial in Acute Liver Failure in 90 participants. Suspended.

Timeline
18 August 2010
Primary endpoint
31 May 2029
31 May 2029

Quick facts

Lead sponsorArbor Research Collaborative for Health
StatusSuspended
Study typeOBSERVATIONAL
Enrollment90
Start date18 August 2010
Primary completion31 May 2029
Estimated completion31 May 2029
Sites16 locations across Canada, United States

Conditions studied

Sponsor

Arbor Research Collaborative for Health

Who can join

Under 18, any sex, with Acute Liver Failure or Mitochondrial Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The specific aims of this study are (1) to determine the clinical phenotypes and natural history of hepatic RC and FAO disorders, (2) to determine the correlation between genotype and phenotype, (3) to determine if circulating biomarkers reflect diagnosis and predict liver disease progression and survival with the native liver, (4) to determine the clinical outcome of these disorders following liver transplantation, and (5) to develop a repository of serum, plasma, urine, tissue and DNA specimens that will be used in ancillary studies. To accomplish these aims, the ChiLDReN investigators at clinical sites (currently 9 sites) will prospectively collect defined data and specimens in a uniform fashion at fixed intervals in a relatively large number of subjects. Clinical information collected from subjects and their parents will enhance the potential for meaningful research in these disorders. A biobank of previously collected subject specimens and DNA samples will be established for use in ancillary studies to be performed in addition to this study.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Clinical spectrum and genetic causes of mitochondrial hepatopathy phenotype in children.
    Squires JE, Miethke AG, Valencia CA, Hawthorne K, et al · · 2023 · cited 9× · PMID 37184518 · DOI 10.1097/hc9.0000000000000139
  2. Protein biomarkers GDF15 and FGF21 to differentiate mitochondrial hepatopathies from other pediatric liver diseases.
    Van Hove JLK, Friederich MW, Strode DK, Van Hove RA, et al · · 2024 · cited 8× · PMID 38180987 · DOI 10.1097/hc9.0000000000000361

Verify or expand the search:

Other recruiting trials for Acute Liver Failure

Currently open trials in the same condition.

Other Arbor Research Collaborative for Health trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing