79
Participants
Start Date
March 12, 2021
Primary Completion Date
July 30, 2021
Study Completion Date
December 20, 2021
Assess the effectiveness and safety of DAAs in patients with IBD.
Variables evaluated: age, gender, location, extent, phenotype, and activity of IBD, treatments, anti-HCV and viral load, DAA treatment and duration, fibrosis and hepatic decompensation and adverse effects (AE).
Evaluate the interaction of DAAs with IBD drugs, particularly immunosuppressants and/or biologics.
Variables evaluated: Interactions.
Assessment of the impact of DAAs on the course of IBD.
Qualitative variables will be expressed as a percentage and 95% confidence interval and quantitative variables as median and interquartile range. A priori it is difficult to determine which statistical analysis should be performed. It is basically a descriptive study, and the subsequent statistical analysis will depend on the evolution that the patients have presented in relation to the DAA treatment. If the drugs have been well tolerated without adverse effects, further statistical analysis will not be necessary. Instead, if the DAAs trigger activity outbreaks, variables related to the appearance of these outbreaks will be evaluated (type of DAA, immunomodulator, ...). To compare whether there are differences between the established groups, Chi Square (in qualitative independent variables), a t-student or ANOVA or their corresponding non-parametric tests (in quantitative independent variables) will be used. Statistical significance has been set at a probability level of \<0.05.
Hospital Universitari Mutua Terrassa, Terrassa
Hospital Mutua de Terrassa
OTHER