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Treatment for Mitochondrial Disease (MITOHEP Trial)

N/A
Waitlist Available
Led By Robert M Merion, MD
Research Sponsored by Arbor Research Collaborative for Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured/assessed at baseline, 6 months, years 1 through 10, and at time of liver transplant, liver or muscle biopsy or hospitalization for critical illness if applicable
Awards & highlights

Summary

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 15 sites) will prospectively collect defined data and specimens in a uniform fashion at fixed intervals in a relatively large number of subjects. Clinical information and DNA samples to be collected from subjects and their parents will enhance the potential for meaningful research in these disorders. A biobank of subject specimens and DNA samples will be established for use in ancillary studies to be performed in addition to this study.

Eligible Conditions
  • Mitochondrial Disease
  • Acute Liver Failure
  • Fatty Acid Oxidation Disorder
  • Liver Disease
  • Mitochondrial Respiratory Chain Deficiencies

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured/assessed at baseline, 6 months, years 1 through 10, and at time of liver transplant, liver or muscle biopsy or hospitalization for critical illness if applicable
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured/assessed at baseline, 6 months, years 1 through 10, and at time of liver transplant, liver or muscle biopsy or hospitalization for critical illness if applicable for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Death
Involvement of other organ systems known to be associated with mitochondrial diseases
Listing for liver transplant
+1 more
Secondary outcome measures
Complications of portal hypertension
Growth failure
Health related Quality of Life
+2 more

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,410 Previous Clinical Trials
4,324,824 Total Patients Enrolled
University of MichiganOTHER
1,833 Previous Clinical Trials
6,423,061 Total Patients Enrolled
Arbor Research Collaborative for HealthLead Sponsor
20 Previous Clinical Trials
35,400 Total Patients Enrolled
~16 spots leftby May 2029
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