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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03489889
Date of registration:	12/01/2018
Prospective Registration:	No
Primary sponsor:	University of Sao Paulo General Hospital
Public title:	Development of Ursodeoxycholic Acid 300 mg at Hospital Das Clinicas of the University of São Paulo School of Medicine
Scientific title:	Development of Ursodeoxycholic Acid 300 mg at Hospital Das Clinicas of the University of São Paulo School of Medicine
Date of first enrolment:	December 2016
Target sample size:	30
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT03489889
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
Brazil

Contacts

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with Primary biliary cholangitis (PBC) was diagnosed when at least two of the
following three criteria: histologically proven early stage PBC; positive
Anti-mitochondrial antibody (AMA) (titer >1:40) and alkaline phosphatase >1.5 times
upper limit of normal at any time since diagnosis.

- Patients had to be on ursodeoxycholic acid for at least 6 months.

- Patients should be able to understand and ready to sign the informed consent form.

Exclusion Criteria:

- Patients not adherent to treatment with reference medicine.

- Known intolerance to the study drugs.

- Patients who withdrew their agreement.

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ursodeoxycholic Acid

Primary Biliary Cirrhosis

Intervention(s)

Drug: Ursodeoxycholic Acid 300mg tablet

Drug: Ursodeoxycholic Acid 300mg capsule

Primary Outcome(s)

Therapeutic efficacy between capsule and tablet [Time Frame: up to 12 months]

Secondary Outcome(s)

Secondary ID(s)

Gastro FMUSP

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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