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Development of Ursodeoxycholic Acid 300 mg at Hospital Das Clinicas of the University of São Paulo School of Medicine

Primary Purpose

Ursodeoxycholic Acid, Primary Biliary Cirrhosis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Ursodeoxycholic Acid 300mg tablet
Ursodeoxycholic Acid 300mg capsule
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ursodeoxycholic Acid focused on measuring Liver Cirrhosis, Biliary, Ursodeoxycholic Acid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

capsule

tablet

Arm Description

pharmaceutical form: capsule ursodeoxycholic acid 300 mg 13-15mg/kg day 3 months

pharmaceutical form: tablet ursodeoxycholic acid 300 mg 13-15mg/kg day 3 months

Outcomes

Primary Outcome Measures

Therapeutic efficacy between capsule and tablet
Compare the liver enzyme parameters (alkaline phosphatase, alanine aminotranferase, aspartate aminotransferase, gamma glutamyl transferase and total bilirubin) in three different moments:before the treatment, between the treatment and at the end of treatment.

Secondary Outcome Measures

Full Information

First Posted
January 12, 2018
Last Updated
October 10, 2018
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03489889
Brief Title
Development of Ursodeoxycholic Acid 300 mg at Hospital Das Clinicas of the University of São Paulo School of Medicine
Official Title
Development of Ursodeoxycholic Acid 300 mg at Hospital Das Clinicas of the University of São Paulo School of Medicine
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A manipulation and an integral part of the pharmaceutical practice, where, in addition to the supply of medicines and personalized products, they represent an alternative to the therapeutic schemes, manipulating drugs of almost all of them as therapeutic categories. One of the products and ursodeoxycholic acid, commercially known as Ursacol, a bile acid physiologically present in human bile, approved by Agência Nacional de Vigilância Sanitária (ANVISA), among several indications, for the treatment of the symptomatic form of primary biliary cholangitis, autoimmune etiology and predominant incidence in female. This is a prospective, cross-over, interventional and open-label study, where patients attending the inclusion and exclusion criteria are attended by the Instituto Central do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (ICHC-FMUSP) Pharmacy Division in the Pharmaceutical Care sector. As patient information as well as the prescribed drugs, compiled by a data collection instrument from the ICHC-FMUSP Pharmacy Division and a semi-structured questionnaire.
Detailed Description
The therapeutic efficacy of Ursodeoxycholic Acid 300 mg tablet and capsules was measured comparing the liver enzyme parameters: alkaline phosphatase, gamma glutamyl transferase, alanine aminotransferase, aspartate aminotransferase and total bilirubin in three times: before treatment begins, in the middle of treatment and at the end of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ursodeoxycholic Acid, Primary Biliary Cirrhosis
Keywords
Liver Cirrhosis, Biliary, Ursodeoxycholic Acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
capsule
Arm Type
Experimental
Arm Description
pharmaceutical form: capsule ursodeoxycholic acid 300 mg 13-15mg/kg day 3 months
Arm Title
tablet
Arm Type
Experimental
Arm Description
pharmaceutical form: tablet ursodeoxycholic acid 300 mg 13-15mg/kg day 3 months
Intervention Type
Drug
Intervention Name(s)
Ursodeoxycholic Acid 300mg tablet
Intervention Description
Cross-over study: Ursodeoxycholic Acid 300mg tablet and after Ursodeoxycholic Acid 300mg capsule
Intervention Type
Drug
Intervention Name(s)
Ursodeoxycholic Acid 300mg capsule
Intervention Description
Cross-over study: Ursodeoxycholic Acid 300mg capsule and after Ursodeoxycholic Acid 300mg tablet
Primary Outcome Measure Information:
Title
Therapeutic efficacy between capsule and tablet
Description
Compare the liver enzyme parameters (alkaline phosphatase, alanine aminotranferase, aspartate aminotransferase, gamma glutamyl transferase and total bilirubin) in three different moments:before the treatment, between the treatment and at the end of treatment.
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
32758152
Citation
Nakano LA, Cancado ELR, Chaves CE, Madeira MCV, Katayose JT, Nabeshima MA, Fossaluza V, Uhrigshardt GG, Liting Z, Pinto VB, Carrilho FJ, Ono SK. A randomized crossover trial to assess therapeutic efficacy and cost reduction of acid ursodeoxycholic manufactured by the university hospital for the treatment of primary biliary cholangitis. BMC Gastroenterol. 2020 Aug 5;20(1):253. doi: 10.1186/s12876-020-01399-5.
Results Reference
derived

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Development of Ursodeoxycholic Acid 300 mg at Hospital Das Clinicas of the University of São Paulo School of Medicine

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