Suspended

Study of Bile Acids in Patients With Peroxisomal Disorders

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What is being tested

chenodeoxycholic acid

+ cholic acid

+ ursodiol

Drug
Who is being recruted

Congenital Abnormalities+43

+ Abnormalities, Multiple

+ Urogenital Diseases

Until 5 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorUniversity of Cincinnati
Last updated: March 25, 2015
Sourced from a government-validated database.Claim as a partner

PROTOCOL OUTLINE: Patients receive oral cholic acid and oral chenodeoxycholic acid on day 1. On day 4, patients receive oral cholic and ursodeoxycholic acids. Patients are assessed at 3 and 6 months for liver function response, neurologic status, and nutritional status. Patients receive treatment until disease progression or unacceptable toxic effects are observed. Completion date provided represents the completion date of the grant per OOPD records

NCT00004442
Principal SponsorUniversity of Cincinnati
Last updated: March 25, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

25 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 5 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Congenital AbnormalitiesAbnormalities, MultipleUrogenital DiseasesAdrenal Gland DiseasesAdrenal InsufficiencyBrain DiseasesBrain Diseases, MetabolicCentral Nervous System DiseasesDemyelinating DiseasesDigestive System DiseasesEndocrine System DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesLipid Metabolism, Inborn ErrorsLipidosesLiver DiseasesIntellectual DisabilityMetabolic DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNervous System DiseasesNeurologic ManifestationsNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesLysosomal Storage DiseasesNeurobehavioral ManifestationsLysosomal Storage Diseases, Nervous SystemHeredodegenerative Disorders, Nervous SystemHereditary Central Nervous System Demyelinating DiseasesBrain Diseases, Metabolic, InbornDisease AttributesGenetic Diseases, InbornX-Linked Intellectual DisabilityGenetic Diseases, X-LinkedLipid Metabolism DisordersFemale Urogenital DiseasesMale Urogenital DiseasesLeukoencephalopathiesAdrenoleukodystrophyMetabolism, Inborn ErrorsSphingolipidosesZellweger SyndromePeroxisomal DisordersRare DiseasesRefsum Disease, Infantile

Criteria

Biochemically proven peroxisomal disorder, including: Zellweger syndrome Pseudo-Zellweger syndrome Neonatal adrenoleukodystrophy Bifunctional enzyme deficiency Infantile Refsum's disease

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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SuspendedNo study centers