NCT05499026

Brief Summary

Retrospective study of CTX patients to investigate the safety and clinical efficacy of Chenodeoxycholic Acid

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2014

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 9, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2015

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 12, 2022

Completed
Last Updated

August 12, 2022

Status Verified

August 1, 2022

Enrollment Period

6 months

First QC Date

August 10, 2022

Last Update Submit

August 10, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Serum Cholestanol Levels

    34 years

Interventions

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

CTX patients

You may qualify if:

  • Diagnosis of CTX Received treatment with CDCA Age between 2 and 75 years Having at least one cholestanol level and/or urinary bile alcohol level no more than 3 months prior to treatment with CDCA and one cholestanol level and/or urinary bile alcohol level post-treatment within 2 years from the beginning of therapy with CDCA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Xanthomatosis, Cerebrotendinous

Interventions

Chenodeoxycholic Acid

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesXanthomatosis

Intervention Hierarchy (Ancestors)

Deoxycholic AcidCholic AcidsBile Acids and SaltsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholanes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2022

First Posted

August 12, 2022

Study Start

December 9, 2014

Primary Completion

June 3, 2015

Study Completion

June 3, 2015

Last Updated

August 12, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share