- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004346
Phase II Study of Cholesterol- and Cholestanol-Free Diet, Lovastatin, and Chenodeoxycholic Acid for Cerebrotendinous Xanthomatosis
Effects of Diet and Medication in Patients With Cerebrotendinous Xanthomatosis (CTX)
OBJECTIVES: I. Assess the biosynthesis of cholesterol and cholestanol, and measure the turnover of individual sterols and bile acids in patients with cerebrotendinous xanthomatosis before and after a cholesterol- and cholestanol-free diet.
II. Assess the biosynthesis of cholesterol and cholestanol, and measure the turnover of individual sterols and bile acids in these patients before and after lovastatin and chenodeoxycholic acid.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PROTOCOL OUTLINE: Following a 2-week baseline assessment, patients participate in a feeding study for up to 3 weeks. The diet is free of cholesterol and cholestanol.
For the next 4 weeks, patients return to their typical diet and are medicated with daily lovastatin and chenodeoxycholic acid.
The feeding study is repeated for an additional 3 weeks, with the patient taking either lovastatin or chenodeoxycholic acid.
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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Oregon
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Portland, Oregon, United States, 97239-3098
- Recruiting
- Oregon Health and Science University
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Contact:
- Sonja Connor
- Phone Number: 503-494-7775
- Email: connors@ohsu.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: William Connor, Oregon Health and Science University
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Genetic Diseases, Inborn
- Metabolism, Inborn Errors
- Lipid Metabolism Disorders
- Lipid Metabolism, Inborn Errors
- Xanthomatosis, Cerebrotendinous
- Xanthomatosis
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Gastrointestinal Agents
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Cathartics
- Chenodeoxycholic Acid
- Lovastatin
- L 647318
- Dihydromevinolin
Other Study ID Numbers
- NCRR-M01RR00334-0067
- OHSU-4008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cerebrotendinous Xanthomatosis
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TRPHARMKlinar CRO; Düzen Laboratories GroupTerminatedCTX - Cerebrotendinous XanthomatosisTurkey
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Travere Therapeutics, Inc.UnknownCerebrotendinous Xanthomatosis (CTX)United States
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Humanis Saglık Anonim SirketiCompleted
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Leadiant Biosciences Ltd.CompletedCerebrotendinous Xanthomatoses
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TRPHARMKlinar CRO; Damagen Genetic Diagnostic CenterEnrolling by invitationXanthomatosis, CerebrotendinousTurkey
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Mirum Pharmaceuticals, Inc.Completed
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TRPHARMKlinar CRO; Düzen Laboratories GroupRecruitingCerebrotendinous XanthomatosisTurkey
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