Inflammatory Bowel DiseasesMIC projectNCT05452187
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
An observational study of Inflammatory Bowel Diseases and Hepatitis C Virus Infection, run by Hospital Mutua de Terrassa at 1 site in Spain.
Trial summary
The prevalence of hepatitis C virus infection (HCV) in patients with inflammatory bowel disease (IBD) ranges from 1-6%. Direct-acting antivirals (DAAs), with cure rates >90%, represent a radical change from interferon-based therapies. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Inflammatory Bowel Diseases, Hepatitis C Virus Infection
- What is being tested?
- Assess the effectiveness and safety of DAAs in patients with IBD., Evaluate the interaction of DAAs with IBD drugs, particularly immunosuppressants and/or biologics. and Assessment of the impact of DAAs on the course of IBD.
- How many people
- 79 participants
- Where
- 1 siteSpain
- Study dates
- 12 Mar 2021to 20 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with HCV Ab (positive/negative) and with RNA (detectable/undetectable) will be identified using the ENEIDA database.
Who may be able to join
- All individuals diagnosed with IBD according to the ECCO criteria and chronic HCV infection (positive HCV Ab and detectable RNA) treated with DAAs and/or interferon collected in the ENEIDA database, and who have properly completed the fields of age, gender, treatment, location, and phenotype of IBD, will be included in the study.
- Study period: Patients treated with DAAs between January 1, 2011 - February 28, 2021.
Who cannot join
- Spontaneous cure of HCV without treatment
- HCV treatment outside the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 (MIC Project).
The prevalence of hepatitis C virus infection (HCV) in patients with inflammatory bowel disease (IBD) ranges from 1-6%. Direct-acting antivirals (DAAs), with cure rates >90%, represent a radical change from interferon-based therapies. The ECCO (European Crohn's and Colitis Organisation) guidelines (Kucharzik T, Ellul P, Greuter T, et al. ECCO Guidelines on the Prevention, Diagnosis, and Management of Infections in Inflammatory Bowel Disease. J Crohn's Colitis. 2021;15(6):879-913) warns about the risk of IBD reactivation due to the effect of DAAs, but HCV management in this situation is uncertain given the lack of evidence.
The project is proposed as the largest retrospective multicenter descriptive study carried out to evaluate the use of DAAs for HCV eradication in patients with IBD. The Eneida database (Zabana Y, Panés J, Nos P, et al. The ENEIDA registry (Nationwide study on genetic and environmental determinants of inflammatory bowel disease) by GETECCU: Design, monitoring, and functions. Gastroenterol y Hepatol. 2020;43(9):551-8.) of the Spanish Working Group on Crohn's Disease and Ulcerative Colitis (GETECCU) is an adequate registry to identify patients with HCV infection. The serological status of the infection is frequently recorded in the ENEIDA database, and it is generally evaluated at the time of IBD diagnosis, before starting immunosuppressive treatment. The ENEIDA registry has the advantage over large population studies that researchers have access to relevant details of the clinical history, which can respond to the controversies raised.
This multicenter retrospective descriptive study will provide useful information to be able to give evidence-based recommendations regarding treatment of HCV in patients with IBD.
Read the detailed description
Hypothesis:
The use of DAAs for HCV eradication in patients with IBD is effective and safe. DAAs do not trigger IBD flares. DAAs probably do not present serious pharmacological interactions, with clinically relevant, with immunosuppressants and/or biological agents.
- Being tested
- Assess the effectiveness and safety of DAAs in patients with IBD., Evaluate the interaction of DAAs with IBD drugs, particularly immunosuppressants and/or biologics., Assessment of the impact of DAAs on the course of IBD.
- Keywords
- Inflammatory Bowel Diseases, Hepatitis C Virus Infection, Direct-acting antiviral drugs
- Medical subject headings
- Inflammatory Bowel Diseases, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assess the effectiveness and safety of DAAs in patients with IBD.Drug
Also called Direct-acting antiviral (DAA) to treat hepatitis C virus (HCV) infection in inflammatory bowel disease (IBD) patients.
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.Drug
Variables evaluated: Interactions.
Assessment of the impact of DAAs on the course of IBD.Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with IBD and chronic HCV infection treated with DAAs and/or interferon. | Cohort patients with IBD and chronic HCV infection treated with DAAs and/or interferon collected from the ENEIDA database. Receives: Drug: Assess the effectiveness and safety of DAAs in patients with IBD.; Drug: Evaluate the interaction of DAAs with IBD drugs, particularly immunosuppressants and/or biologics.; Other: Assessment of the impact of DAAs on the course of IBD. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of sustained viral response (effectiveness) in patients with IBD and HCV infection treated with DAAs.
Measured: 8 weeks
Number and description of adverse events (safety) and possible interactions of DAAs with IBD drugs, particularly immunosuppressants and/or biologics.
Measured: 8 weeks
Secondary outcomes (2)
Compare the clinical Crohn's disease activity (measured by Harvey Bradshaw Index) before and during the treatment with DAAs, to assess the impact of DAAs on the course of IBD.
Harvey Bradshaw Index (HBI) for Crohn's disease (CD): The minimum score obtainable is 0, which indicates the absence of disease. The maximum attainable score depends on the number of stools the patient identifies per day, however, it is in the range of 18.
HBI score interpretation: < 5 remission, 5-7 points (mild activity), 8-16 points (moderate activity), > 16 points (severe activity).
Measured: 8 weeks
Compare the clinical ulcerative colitis activity (measured by Partial Mayo Score) before and during the treatment with DAAs, to assess the impact of DAAs on the course of IBD.
Partial Mayo Score in ulcerative colitis (UC): The minimum score obtainable is 0, which indicates the absence of disease. The maximum attainable score is 9.
Partial Mayo score interpretation: < 2 remission, 2-4 points (mild activity), 5-7 points (moderate activity), >7 points (severe activity).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start12 Mar 2021
- Primary completion30 Jul 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Mutua de Terrassa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Esteve, PhD, MD, Principal investigator, Hospital Universitari Mútua Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452187
- Sponsor's protocol ID
- MIC2020
- Acronym
- MIC project
- Status last verified
- Jul 2022
- First submitted
- 10 Jun 2022
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kucharzik T, Ellul P, Greuter T, Rahier JF, Verstockt B, Abreu C, Albuquerque A, Allocca M, Esteve M, Farraye FA, Gordon H, Karmiris K, Kopylov U, Kirchgesner J, MacMahon E, Magro F, Maaser C, de Ridder L, Taxonera C, Toruner M, Tremblay L, Scharl M, Viget N, Zabana Y, Vavricka S. ECCO Guidelines on the Prevention, Diagnosis, and Management of Infections in Inflammatory Bowel Disease. J Crohns Colitis. 2021 Jun 22;15(6):879-913. doi: 10.1093/ecco-jcc/jjab052. No abstract available.
PubMed 33730753Zabana Y, Panes J, Nos P, Gomollon F, Esteve M, Garcia-Sanchez V, Gisbert JP, Barreiro-de-Acosta M, Domenech E; en representacion de GETECCU. The ENEIDA registry (Nationwide study on genetic and environmental determinants of inflammatory bowel disease) by GETECCU: Design, monitoring and functions. Gastroenterol Hepatol. 2020 Nov;43(9):551-558. doi: 10.1016/j.gastrohep.2020.05.007. Epub 2020 Jul 14. English, Spanish.
PubMed 32674882
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 (MIC Project).
- ClinicalTrials.gov ID
- NCT05452187
- Acronym / sponsor ID
- MIC project / MIC2020
- Keywords
- Inflammatory Bowel Diseases, Hepatitis C Virus Infection, Direct-acting antiviral drugs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Hospital Mutua de TerrassaUniversity, hospital or other
- Study start
- 12 Mar 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The prevalence of hepatitis C virus infection (HCV) in patients with inflammatory bowel disease (IBD) ranges from 1-6%. Direct-acting antivirals (DAAs), with cure rates >90%, represent a radical change from interferon-based therapies. The ECCO (European Crohn's and Colitis Organisation) guidelines (Kucharzik T, Ellul P, Greuter T, et al. ECCO Guidelines on the Prevention, Diagnosis, and Management of Infections in Inflammatory Bowel Disease. J Crohn's Colitis. 2021;15(6):879-913) warns about the risk of IBD reactivation due to the effect of DAAs, but HCV management in this situation is uncertain given the lack of evidence.
The project is proposed as the largest retrospective multicenter descriptive study carried out to evaluate the use of DAAs for HCV eradication in patients with IBD. The Eneida database (Zabana Y, Panés J, Nos P, et al. The ENEIDA registry (Nationwide study on genetic and environmental determinants of inflammatory bowel disease) by GETECCU: Design, monitoring, and functions. Gastroenterol y Hepatol. 2020;43(9):551-8.) of the Spanish Working Group on Crohn's Disease and Ulcerative Colitis (GETECCU) is an adequate registry to identify patients with HCV infection. The serological status of the infection is frequently recorded in the ENEIDA database, and it is generally evaluated at the time of IBD diagnosis, before starting immunosuppressive treatment. The ENEIDA registry has the advantage over large population studies that researchers have access to relevant details of the clinical history, which can respond to the controversies raised.
This multicenter retrospective descriptive study will provide useful information to be able to give evidence-based recommendations regarding treatment of HCV in patients with IBD.
Detailed description
Hypothesis:
The use of DAAs for HCV eradication in patients with IBD is effective and safe. DAAs do not trigger IBD flares. DAAs probably do not present serious pharmacological interactions, with clinically relevant, with immunosuppressants and/or biological agents.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with IBD and chronic HCV infection treated with DAAs and/or interferon. | – | Drug: Assess the effectiveness and safety of DAAs in patients with IBD., Drug: Evaluate the interaction of DAAs with IBD drugs, particularly immunosuppressants and/or biologics., Other: Assessment of the impact of DAAs on the course of IBD.Cohort patients with IBD and chronic HCV infection treated with DAAs and/or interferon collected from the ENEIDA database. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with HCV Ab (positive/negative) and with RNA (detectable/undetectable) will be identified using the ENEIDA database.
Key inclusion criteria (2 listed)
- All individuals diagnosed with IBD according to the ECCO criteria and chronic HCV infection (positive HCV Ab and detectable RNA) treated with DAAs and/or interferon collected in the ENEIDA database, and who have properly completed the fields of age, gender, treatment, location, and phenotype of IBD, will be included in the study.
- Study period: Patients treated with DAAs between January 1, 2011 - February 28, 2021.
Key exclusion criteria (2 listed)
- Spontaneous cure of HCV without treatment
- HCV treatment outside the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assess the effectiveness and safety of DAAs in patients with IBD.Also: Direct-acting antiviral (DAA) to treat hepatitis C virus (HCV) infection in inflammatory bowel disease (IBD) patients.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 | Patients with IBD and chronic HCV infection treated with DAAs and/or interferon. |
| Evaluate the interaction of DAAs with IBD drugs, particularly immunosuppressants and/or biologics.Variables evaluated: Interactions. | Drug | Patients with IBD and chronic HCV infection treated with DAAs and/or interferon. |
| 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. | Other | Patients with IBD and chronic HCV infection treated with DAAs and/or interferon. |
Primary outcome
Percentage of sustained viral response (effectiveness) in patients with IBD and HCV infection treated with DAAs.
Time frame: 8 weeks
Number and description of adverse events (safety) and possible interactions of DAAs with IBD drugs, particularly immunosuppressants and/or biologics.
Time frame: 8 weeks
2 secondary outcomes
Compare the clinical Crohn's disease activity (measured by Harvey Bradshaw Index) before and during the treatment with DAAs, to assess the impact of DAAs on the course of IBD.
Time frame: 8 weeks
Compare the clinical ulcerative colitis activity (measured by Partial Mayo Score) before and during the treatment with DAAs, to assess the impact of DAAs on the course of IBD.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Background: PubMed 33730753Kucharzik T, Ellul P, Greuter T, Rahier JF, Verstockt B, Abreu C, Albuquerque A, Allocca M, Esteve M, Farraye FA, Gordon H, Karmiris K, Kopylov U, Kirchgesner J, MacMahon E, Magro F, Maaser C, de Ridder L, Taxonera C, Toruner M, Tremblay L, Scharl M, Viget N, Zabana Y, Vavricka S. ECCO Guidelines on the Prevention, Diagnosis, and Management of Infections in Inflammatory Bowel Disease. J Crohns Colitis. 2021 Jun 22;15(6):879-913. doi: 10.1093/ecco-jcc/jjab052. No abstract available.
- Background: PubMed 32674882Zabana Y, Panes J, Nos P, Gomollon F, Esteve M, Garcia-Sanchez V, Gisbert JP, Barreiro-de-Acosta M, Domenech E; en representacion de GETECCU. The ENEIDA registry (Nationwide study on genetic and environmental determinants of inflammatory bowel disease) by GETECCU: Design, monitoring and functions. Gastroenterol Hepatol. 2020 Nov;43(9):551-558. doi: 10.1016/j.gastrohep.2020.05.007. Epub 2020 Jul 14. English, Spanish.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Esteve, PhD, MD principal investigator
Hospital Universitari Mútua Terrassa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Hepatitis C Virus Infection, run by Hospital Mutua de Terrassa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of sustained viral response (effectiveness) in patients with IBD and HCV infection treated with DAAs. (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05452187, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022.