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The Effect of Bezafibrate on Cholestatic Itch (FITCH)

Primary Purpose

Primary Biliary Cholangitis, Primary Sclerosing Cholangitis, Secondary Sclerosing Cholangitis

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bezafibrate
Placebo
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Biliary Cholangitis focused on measuring Pruritus, itch, cholestasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Sites / Locations

  • Academic Medical CenterRecruiting
  • Vrije Universiteit Medisch CentrumRecruiting
  • Universitair Medisch Centrum GroningenRecruiting
  • Leids Universitair Medisch CentrumRecruiting
  • Maastricht Universitair Medisch CentrumRecruiting
  • Radboud Universitair Medisch CentrumRecruiting
  • Erasmus Medisch CentrumRecruiting
  • Universitair Medisch Centrum UtrechtRecruiting
  • University of Barcelona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bezafibrate

Placebo

Arm Description

Bezalip retard 400mg tablet

Placebo 400mg tablet

Outcomes

Primary Outcome Measures

Proportion of patients with a reduction in itch intensity of 50% or more

Secondary Outcome Measures

Serum liver tests
Serum creatinine
Serum cholesterol
Serum autotaxin activity
Serum creatinin kinase

Full Information

First Posted
March 2, 2016
Last Updated
March 4, 2016
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
Erasmus Medical Center, University Medical Center Groningen, Leiden University Medical Center, UMC Utrecht, Radboud University Medical Center, Maastricht University Medical Center, Free University Medical Center, University of Barcelona, Ludwig-Maximilians - University of Munich, Friedrich-Alexander-Universität Erlangen-Nürnberg, Istituto Clinico Humanitas
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1. Study Identification

Unique Protocol Identification Number
NCT02701166
Brief Title
The Effect of Bezafibrate on Cholestatic Itch
Acronym
FITCH
Official Title
The Effect of Bezafibrate on Cholestatic Itch
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
Erasmus Medical Center, University Medical Center Groningen, Leiden University Medical Center, UMC Utrecht, Radboud University Medical Center, Maastricht University Medical Center, Free University Medical Center, University of Barcelona, Ludwig-Maximilians - University of Munich, Friedrich-Alexander-Universität Erlangen-Nürnberg, Istituto Clinico Humanitas

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Randomized double blind placebo controlled trial to evaluate the antipruritic effect of bezafibrate in patients with moderate to severe cholestatic itch.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Biliary Cholangitis, Primary Sclerosing Cholangitis, Secondary Sclerosing Cholangitis
Keywords
Pruritus, itch, cholestasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bezafibrate
Arm Type
Experimental
Arm Description
Bezalip retard 400mg tablet
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 400mg tablet
Intervention Type
Drug
Intervention Name(s)
Bezafibrate
Other Intervention Name(s)
bezalip
Intervention Description
bezafibrate 400mg per day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo 400mg per day
Primary Outcome Measure Information:
Title
Proportion of patients with a reduction in itch intensity of 50% or more
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Serum liver tests
Time Frame
3 weeks
Title
Serum creatinine
Time Frame
3 weeks
Title
Serum cholesterol
Time Frame
3 weeks
Title
Serum autotaxin activity
Time Frame
3 weeks
Title
Serum creatinin kinase
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Facility Information:
Facility Name
Academic Medical Center
City
Amsterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulrich Beuers, prof. dr.
Phone
+31205662422
Email
u.h.beuers@amc.uva.nl
First Name & Middle Initial & Last Name & Degree
Ruth Bolier
Phone
+31205668701
Email
a.r.bolier@amc.uva.nl
First Name & Middle Initial & Last Name & Degree
Ulrich Beuers, prof. dr.
First Name & Middle Initial & Last Name & Degree
Elsemieke de Vries
Facility Name
Vrije Universiteit Medisch Centrum
City
Amsterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karin van Nieuwkerk, dr.
Phone
+31-20-4440613
Email
cmj.vannieuwkerk@vumc.nl
First Name & Middle Initial & Last Name & Degree
Ineke Jansen
Phone
+31-20-4449455
Email
a.jansen1@vumc.nl
Facility Name
Universitair Medisch Centrum Groningen
City
Groningen
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marleen de Vree, dr.
Phone
+31-6-55256255
Email
j.m.l.de.vree@umcg.nl
First Name & Middle Initial & Last Name & Degree
Lyda Engelsman
Phone
+31-50-3614996
Email
a.f.engelsman@umcg.nl
Facility Name
Leids Universitair Medisch Centrum
City
Leiden
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bart van Hoek, prof. dr.
Phone
+31-71-5263507
Email
b.van_hoek@lumc.nl
First Name & Middle Initial & Last Name & Degree
Lida Beneken Kolmer
Phone
+31-71-5261188
Email
a.beneken_kolmer@lumc.nl
Facility Name
Maastricht Universitair Medisch Centrum
City
Maastricht
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Jansen, prof. dr.
Phone
+31-43-3876543
Email
plm.jansen@maastrichtuniversity.nl
First Name & Middle Initial & Last Name & Degree
Tine Horsten
Phone
+31-43-3874436
Email
t.horsten@mumc.nl
Facility Name
Radboud Universitair Medisch Centrum
City
Nijmegen
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joost Drenth, prof. dr.
Phone
+31-24-3613999
Email
joostphdrenth@cs.com
First Name & Middle Initial & Last Name & Degree
Sonja Cuppen
Phone
+31-24-3619190
Email
researchunit.mdl@radboudumc.nl
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henk van Buuren, dr.
Phone
+31-10-7035942
Email
h.vanbuuren@erasmusmc.nl
First Name & Middle Initial & Last Name & Degree
Maren Harms
Phone
+31-10-7038922
Email
m.h.harms@erasmusmc.nl
Facility Name
Universitair Medisch Centrum Utrecht
City
Utrecht
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karel van Erpecum, dr.
Phone
+31-88-7555555
Email
k.j.vanerpecum@umcutrecht.nl
First Name & Middle Initial & Last Name & Degree
Janneke van den Brink
Phone
+31-88-7557973
Email
j.vandenbrink@umcutrecht.nl
Facility Name
University of Barcelona
City
Barcelona
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Albert Parés, dr.
Phone
+34-93-2275753
Email
pares@ub.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33031833
Citation
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.
Results Reference
derived
PubMed Identifier
28535810
Citation
Bolier 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.
Results Reference
derived

Learn more about this trial

The Effect of Bezafibrate on Cholestatic Itch

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