Primary Biliary CholangitisPhase 3FITCHNCT02701166
The Effect of Bezafibrate on Cholestatic Itch
A Phase 3 study testing Bezafibrate in people with Primary Biliary Cholangitis and Primary Sclerosing Cholangitis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 9 sites in 2 countries.
Trial summary
Randomized double blind placebo controlled trial to evaluate the antipruritic effect of bezafibrate in patients with moderate to severe cholestatic itch. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Biliary Cholangitis, Primary Sclerosing Cholangitis, Secondary Sclerosing Cholangitis
- What is being tested?
- Bezafibrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Feb 2016to Apr 2018
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of primary biliary cholangitis or primary/secondary sclerosing cholangitis as defined by EASL clinical practice guidelines of cholestasis 2009;
- itch without primary dermatologic abnormalities and with an intensity score of ≥ 5.0 cm on a scale from 0.0 cm (no itch) to 10.0 cm (worst itch possible), scored twice in the week before inclusion.
Who cannot join
- Concomitant guideline-recommended as well as experimental antipruritic therapy, e.g.
- rifampicin, opioid-receptor antagonists (naltrexon, naloxone), serotonin-reuptake inhibitors (sertraline), ondansetron, phenobarbital, propofol, lidocaine, dronabinol, butorphanol, internal or external biliary drainage, extracorporeal albumin dialysis, ultraviolet-B phototherapy; NB. Topical menthol containing agents are allowed, as well as bile salt sequestrants (colesevelam, cholestyramin) as long as taken at least 4 hours before or after intake of the study medication. Incidental use of these agents should be noted by patients in the diary, structural use should be noted on the CRF (section co-medication);
- Pregnancy, women of childbearing potential not using contraception, breast feeding;
- Cholestasis due to obstruction that requires invasive desobstructive treatment within the time scope of the study (5 weeks), such as endoscopic retrograde cholangiopancreaticography (ERCP) or surgical removal of a tumor compressing the bile duct;
- Use of opiates;
- Renal insufficiency (creatinine clearance <60mL/min).
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Netherlands8 sites, 8 recruiting
- Recruiting
Academic Medical Center
Amsterdam
Ulrich Beuers, prof. dr., +31205662422, u.h.beuers@amc.uva.nl
Ruth Bolier, +31205668701, a.r.bolier@amc.uva.nl
- Recruiting
Vrije Universiteit Medisch Centrum
Amsterdam
Karin van Nieuwkerk, dr., +31-20-4440613, cmj.vannieuwkerk@vumc.nl
Ineke Jansen, +31-20-4449455, a.jansen1@vumc.nl
- Recruiting
Universitair Medisch Centrum Groningen
Groningen
Marleen de Vree, dr., +31-6-55256255, j.m.l.de.vree@umcg.nl
Lyda Engelsman, +31-50-3614996, a.f.engelsman@umcg.nl
- Recruiting
Leids Universitair Medisch Centrum
Leiden
Bart van Hoek, prof. dr., +31-71-5263507, b.van_hoek@lumc.nl
Lida Beneken Kolmer, +31-71-5261188, a.beneken_kolmer@lumc.nl
- Recruiting
Maastricht Universitair Medisch Centrum
Maastricht
Peter Jansen, prof. dr., +31-43-3876543, plm.jansen@maastrichtuniversity.nl
Tine Horsten, +31-43-3874436, t.horsten@mumc.nl
- Recruiting
Radboud Universitair Medisch Centrum
Nijmegen
Joost Drenth, prof. dr., +31-24-3613999, joostphdrenth@cs.com
Sonja Cuppen, +31-24-3619190, researchunit.mdl@radboudumc.nl
- Recruiting
Erasmus Medisch Centrum
Rotterdam
Henk van Buuren, dr., +31-10-7035942, h.vanbuuren@erasmusmc.nl
Maren Harms, +31-10-7038922, m.h.harms@erasmusmc.nl
- Recruiting
Universitair Medisch Centrum Utrecht
Utrecht
Karel van Erpecum, dr., +31-88-7555555, k.j.vanerpecum@umcutrecht.nl
Janneke van den Brink, +31-88-7557973, j.vandenbrink@umcutrecht.nl
Spain1 site, 1 recruiting
- Not yet recruiting
University of Barcelona
Barcelona
Albert Parés, dr., +34-93-2275753, pares@ub.edu
About this study
Randomized double blind placebo controlled trial to evaluate the antipruritic effect of bezafibrate in patients with moderate to severe cholestatic itch.
- Conditions
- Primary Biliary Cholangitis, Primary Sclerosing Cholangitis, Secondary Sclerosing Cholangitis
- Being tested
- Bezafibrate, Placebo
- Keywords
- Pruritus, itch, cholestasis
- Medical subject headings
- Liver Cirrhosis, Biliary, Cholangitis, Sclerosing, Pruritus, Cholestasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BezafibrateDrug
Also called bezalip
bezafibrate 400mg per day
PlaceboDrug
placebo 400mg per day
| Study group | Role | What they receive |
|---|---|---|
| Bezafibrate | Experimental | Bezalip retard 400mg tablet Receives: Drug: Bezafibrate |
| Placebo | Placebo comparator | Placebo 400mg tablet Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with a reduction in itch intensity of 50% or more
Measured: 3 weeks
Secondary outcomes (5)
Serum liver tests
Measured: 3 weeks
Serum creatinine
Measured: 3 weeks
Serum cholesterol
Measured: 3 weeks
Serum autotaxin activity
Measured: 3 weeks
Serum creatinin kinase
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2018 (estimated)
- Study completionApr 2018 (estimated)
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 Primary Biliary CholangitisStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center, University Medical Center Groningen, Leiden University Medical Center, UMC Utrecht, Radboud University Medical Center, Maastricht University Medical Center, Universitair Ziekenhuis Brussel, University of Barcelona, Ludwig-Maximilians - University of Munich, Friedrich-Alexander-Universität Erlangen-Nürnberg, Istituto Clinico Humanitas
- Responsible party
- Principal investigator, Ruth Bolier, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701166
- Sponsor's protocol ID
- NL48885.018.15
- Acronym
- FITCH
- Status last verified
- Mar 2016
- First submitted
- 2 Mar 2016
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
de Vries E, Bolier R, Goet J, Pares A, Verbeek J, de Vree M, Drenth J, van Erpecum K, van Nieuwkerk K, van der Heide F, Mostafavi N, Helder J, Ponsioen C, Oude Elferink R, van Buuren H, Beuers U; Netherlands Association for the Study of the Liver-Cholestasis Working Group. Fibrates for Itch (FITCH) in Fibrosing Cholangiopathies: A Double-Blind, Randomized, Placebo-Controlled Trial. Gastroenterology. 2021 Feb;160(3):734-743.e6. doi: 10.1053/j.gastro.2020.10.001. Epub 2020 Oct 5.
PubMed 33031833Bolier R, de Vries ES, Pares A, Helder J, Kemper EM, Zwinderman K, Elferink RPO, Beuers U; Netherlands Association for the Study of the Liver (NASL) Cholestatic Liver Diseases Study Group. Fibrates for the treatment of cholestatic itch (FITCH): study protocol for a randomized controlled trial. Trials. 2017 May 23;18(1):230. doi: 10.1186/s13063-017-1966-8.
PubMed 28535810
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bezafibrate on Cholestatic Itch
- ClinicalTrials.gov ID
- NCT02701166
- Acronym / sponsor ID
- FITCH / NL48885.018.15
- Conditions
- Primary Biliary Cholangitis, Primary Sclerosing Cholangitis, Secondary Sclerosing Cholangitis
- Keywords
- Pruritus, itch, cholestasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Erasmus Medical Center, University Medical Center Groningen, Leiden University Medical Center, UMC Utrecht, Radboud University Medical Center, Maastricht University Medical Center, Universitair Ziekenhuis Brussel, University of Barcelona, Ludwig-Maximilians - University of Munich, Friedrich-Alexander-Universität Erlangen-Nürnberg, Istituto Clinico Humanitas
- Study start
- Feb 2016
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 8 Mar 2016 (estimated)
- 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.
Randomized double blind placebo controlled trial to evaluate the antipruritic effect of bezafibrate in patients with moderate to severe cholestatic itch.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bezafibrate | Experimental | Drug: BezafibrateBezalip retard 400mg tablet |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 400mg tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis of primary biliary cholangitis or primary/secondary sclerosing cholangitis as defined by EASL clinical practice guidelines of cholestasis 2009;
- itch without primary dermatologic abnormalities and with an intensity score of ≥ 5.0 cm on a scale from 0.0 cm (no itch) to 10.0 cm (worst itch possible), scored twice in the week before inclusion.
Key exclusion criteria (6 listed)
- Concomitant guideline-recommended as well as experimental antipruritic therapy, e.g.
- rifampicin, opioid-receptor antagonists (naltrexon, naloxone), serotonin-reuptake inhibitors (sertraline), ondansetron, phenobarbital, propofol, lidocaine, dronabinol, butorphanol, internal or external biliary drainage, extracorporeal albumin dialysis, ultraviolet-B phototherapy; NB. Topical menthol containing agents are allowed, as well as bile salt sequestrants (colesevelam, cholestyramin) as long as taken at least 4 hours before or after intake of the study medication. Incidental use of these agents should be noted by patients in the diary, structural use should be noted on the CRF (section co-medication);
- Pregnancy, women of childbearing potential not using contraception, breast feeding;
- Cholestasis due to obstruction that requires invasive desobstructive treatment within the time scope of the study (5 weeks), such as endoscopic retrograde cholangiopancreaticography (ERCP) or surgical removal of a tumor compressing the bile duct;
- Use of opiates;
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 |
|---|---|---|
| BezafibrateAlso: bezalipbezafibrate 400mg per day | Drug | Bezafibrate |
| Placeboplacebo 400mg per day | Drug | Placebo |
Primary outcome
Proportion of patients with a reduction in itch intensity of 50% or more
Time frame: 3 weeks
5 secondary outcomes
Serum liver tests
Time frame: 3 weeks
Serum creatinine
Time frame: 3 weeks
Serum cholesterol
Time frame: 3 weeks
Serum autotaxin activity
Time frame: 3 weeks
Serum creatinin kinase
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
- Derived from this study: PubMed 33031833de Vries E, Bolier R, Goet J, Pares A, Verbeek J, de Vree M, Drenth J, van Erpecum K, van Nieuwkerk K, van der Heide F, Mostafavi N, Helder J, Ponsioen C, Oude Elferink R, van Buuren H, Beuers U; Netherlands Association for the Study of the Liver-Cholestasis Working Group. Fibrates for Itch (FITCH) in Fibrosing Cholangiopathies: A Double-Blind, Randomized, Placebo-Controlled Trial. Gastroenterology. 2021 Feb;160(3):734-743.e6. doi: 10.1053/j.gastro.2020.10.001. Epub 2020 Oct 5.
- Derived from this study: PubMed 28535810Bolier R, de Vries ES, Pares A, Helder J, Kemper EM, Zwinderman K, Elferink RPO, Beuers U; Netherlands Association for the Study of the Liver (NASL) Cholestatic Liver Diseases Study Group. Fibrates for the treatment of cholestatic itch (FITCH): study protocol for a randomized controlled trial. Trials. 2017 May 23;18(1):230. doi: 10.1186/s13063-017-1966-8.
- Individual participant dataSharing planned: Undecided
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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.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bezafibrate in people with Primary Biliary Cholangitis and Primary Sclerosing Cholangitis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 9 sites in 2 countries.
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 6 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: status not confirmed, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Netherlands, 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with a reduction in itch intensity of 50% or more (time frame: 3 weeks). 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 NCT02701166, 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 8 Mar 2016.