Study of Tauroursodeoxycholic Acid for Hepatobiliary Disease in Cystic Fibrosis
Sponsor: Children's Hospital Medical Center, Cincinnati
A NA clinical study on Cystic Fibrosis, this trial is completed. The trial is conducted by Children's Hospital Medical Center, Cincinnati and has accumulated 6 data snapshots since 1997. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)PROTOCOL OUTLINE: Objective I: This part of the study is a dose-response study to determine the optimal dose of tauroursodeoxycholic acid (TUDCA). Twenty-four patients are randomized to receive one of three different doses of TUDCA for 3 months.
Objective II: This part of the study is a double-blind crossover study to compare optimized doses of TUDCA with optimized doses of ursodiol in 15 patients stratified according to age (less than 10 vs 10-20 vs more than 20 years). Patients are randomized to receive either TUDCA or ursodiol orally for an initial 3 month period, followed by a 3 month washout period in which no drug is administered. Patients then receive the alternate drug for 3 months.
Completion date provided represents the completion date of the grant per OOPD records
PROTOCOL OUTLINE: Objective I: This part of the study is a dose-response study to determine the optimal dose of tauroursodeoxycholic acid (TUDCA). Twenty-four patients are randomized to receive one of three different doses of TUDCA for 3 months.
Objective II: This part of the study is a double-blind crossover study to compare optimized doses of TUDCA with optimized doses of ursodiol in 15 patients stratified according to age (less than 10 vs 10-20 vs more than 20 years). Patients are randomized to receive either TUDCA or ursodiol orally for an initial 3 month period, followed by a 3 month washout period in which no drug is administered. Patients then receive the alternate drug for 3 months.
Completion date provided represents the completion date of the grant per OOPD records
Status Flow
Change History
6 versions recorded-
Jan 2026 — Present [monthly]
Completed NA
-
Sep 2024 — Present [monthly]
Completed NA
-
Jul 2024 — Sep 2024 [monthly]
Completed NA
-
Jan 2021 — Jul 2024 [monthly]
Completed NA
-
Jun 2018 — Jan 2021 [monthly]
Completed NA
▶ Show 1 earlier version
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Jan 2017 — Jun 2018 [monthly]
Completed NA
First recorded
Sep 1997
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Children's Hospital Medical Center, Cincinnati
For direct contact, visit the study record on ClinicalTrials.gov .