Hepatotoxicity
Conditions
Brief summary
The proportion of patients that achieve a decrease of at least 50% of the peak value in TBL at day 14., Time (days) to TBL value return to normal., Proportion of AEs, SAEs, fatality, and proportion of patients with premature termination due to AEs.
Detailed description
The proportion of patients that achieve a decrease of at least 50% of the peak value in ALT, AST and INR at day 7., Time (days) for the ALT, AST and INR values return to normal., Proportion of patients that develop acute liver failure, need for liver transplantation or liver related death at day 28., Score changes in SF-36 quality of life validated questionnaire performed at visit 1 (day 1, start of treatment) and at visit 6 (day 35, end of treatment).
Interventions
DRUGDecortin 5 mg tablete
DRUGMICROCRYSTALLINE CELLULOSE
Sponsors
Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients that achieve a decrease of at least 50% of the peak value in TBL at day 14., Time (days) to TBL value return to normal., Proportion of AEs, SAEs, fatality, and proportion of patients with premature termination due to AEs. | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients that achieve a decrease of at least 50% of the peak value in ALT, AST and INR at day 7., Time (days) for the ALT, AST and INR values return to normal., Proportion of patients that develop acute liver failure, need for liver transplantation or liver related death at day 28., Score changes in SF-36 quality of life validated questionnaire performed at visit 1 (day 1, start of treatment) and at visit 6 (day 35, end of treatment). | — |
Countries
Spain
Outcome results
None listed