Evaluation of the Safety and Effectiveness of Direct-acting Antiviral Drugs in the Treatment of Hepatitis C in Patients With Inflammatory Bowel Disease: National Multicenter Study

CompletedOBSERVATIONAL
Enrollment

79

Participants

Timeline

Start Date

March 12, 2021

Primary Completion Date

July 30, 2021

Study Completion Date

December 20, 2021

Conditions
Inflammatory Bowel DiseasesHepatitis C Virus Infection
Interventions
DRUG

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).

DRUG

Evaluate the interaction of DAAs with IBD drugs, particularly immunosuppressants and/or biologics.

Variables evaluated: Interactions.

OTHER

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.

Trial Locations (1)

08221

Hospital Universitari Mutua Terrassa, Terrassa

All Listed Sponsors
lead

Hospital Mutua de Terrassa

OTHER

NCT05452187 - Evaluation of the Safety and Effectiveness of Direct-acting Antiviral Drugs in the Treatment of Hepatitis C in Patients With Inflammatory Bowel Disease: National Multicenter Study | Biotech Hunter | Biotech Hunter