Primary Biliary Cholangitis/Cirrhosis (PBC)
Conditions
Interventions
-Group A: Ursodeoxycholic acid 300mg produced at hospital in tablets (15 patients) for 3 months and Ursodeoxycholic acid 300mg produced at hospital in capsules (15 patients) for 3 months.
-Group B:
Drug
VS1.001.003.001.001.005.006
Sponsors
Hospital das Clínicas
Faculdade de Medicina da Universidade de São Paulo
Eligibility
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Diagnosis of Primary Biliary Cholangitis; Male or female; 18 years old; and atients on regular treatment for at least 6 months with commercial drug (Ursacol)
Exclusion criteria
Exclusion criteria: Any other co-existing liver diseases; pregnancy; -withdrawal of consent; patients not adherent to treatment with reference drug and known intolerance to the study drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the non-inferiority of the manipulated drugs in capsule and tablet in relation to the commercial Ursacol drug using the alkaline phosphatase,considering 1.5x upper limit of normality.;The results showed the non-inferiority of the drugs manipulated in the capsule and tablet presentations relative to the commercial drug Ursacol. | — |
Secondary
| Measure | Time frame |
|---|---|
| Analysing the cost of manipulated ursodeoxycholic acid in relation to commercial drug purchased by public institutions.;The use of the manipulated drug showed a reduction of 67.3% when compared to the commercial drug.;Avalue the occurrence of adverse events to the use of manipulated drugs.;There were no serious drug-related adverse events manipulated. | — |
Countries
Brazil
Contacts
Public ContactCleuber Chaves
Hospital das Clínicas
Outcome results
None listed