Chronic Liver DiseasePhase 2/3COPENCT00756171
Colesevelam Versus Placebo in Cholestatic Pruritus
A Phase 2/3 study testing colesevelam in people with Chronic Liver Disease, run by Foundation for Liver Research at 3 sites in Netherlands.
Trial summary
38 patients with pruritus due to chronic cholestatic liver disease will be evaluated in an investigator initiated, multicenter, double-blind, placebo-controlled, 3-week study assessing the effects of colesevelam on pruritus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Liver Disease
- What is being tested?
- colesevelam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 3 sitesNetherlands
- Study dates
- Sep 2008to Dec 2009
- Phase
- Phase 2/3
- 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
- patients with pruritus as a result of a cholestatic disorder
- age above 18 years
- informed consent
Who cannot join
- use of cholestyramine
- pregnancy
- inability to understand or speak Dutch language
- malignancy/life expectancy <6 months
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Amsterdam Medical Center
Amsterdam
Erasmus Medical Center
Rotterdam
University Medical Center Utrecht
Utrecht
About this study
Official title: Colesevelam Versus Placebo in Cholestatic Pruritus. A Double-blind, Placebo-controlled Study
38 patients with pruritus due to chronic cholestatic liver disease will be evaluated in an investigator initiated, multicenter, double-blind, placebo-controlled, 3-week study assessing the effects of colesevelam on pruritus. Colesevelam is an oral, non-absorbable bile-acid sequestrant much more potent than cholestyramine but free of adverse effects. It is registered as a lipid lowering agent. The intensity of symptoms will be scored by means of daily Visual Analogue Scales (VAS). Fatigue, quality of life and cutaneous scratch lesions will also be evaluated using quantitative instruments.
- Conditions
- Chronic Liver Disease
- Being tested
- colesevelam, placebo
- Keywords
- Cholestatic, pruritus, of any cause
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colesevelamDrug
Also called Cholestagel
2 times 3 625 mg tablets daily, 3 weeks
placeboDrug
2 times 3 625mg tablets daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Verum; colesevelam Receives: Drug: colesevelam |
| 2 | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
40% reduction of pruritus according to visual analogue scores
Measured: 3 weeks
Secondary outcomes (2)
improvement in quality of life scores
Measured: 3 weeks
Reduction in pruritus score/scratch lesions
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 posted19 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionMay 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Liver DiseaseStudies 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Liver Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00756171
- Sponsor's protocol ID
- COPE_08
- Acronym
- COPE
- Status last verified
- Dec 2012
- First submitted
- 18 Sep 2008
- Last updated
- 18 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kuiper EM, van Erpecum KJ, Beuers U, Hansen BE, Thio HB, de Man RA, Janssen HL, van Buuren HR. The potent bile acid sequestrant colesevelam is not effective in cholestatic pruritus: results of a double-blind, randomized, placebo-controlled trial. Hepatology. 2010 Oct;52(4):1334-40. doi: 10.1002/hep.23821.
PubMed 20683930
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colesevelam Versus Placebo in Cholestatic Pruritus. A Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT00756171
- Acronym / sponsor ID
- COPE / COPE_08
- Conditions
- Chronic Liver Disease
- Keywords
- Cholestatic, pruritus, of any cause
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Foundation for Liver ResearchUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 19 Sep 2008 (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.
38 patients with pruritus due to chronic cholestatic liver disease will be evaluated in an investigator initiated, multicenter, double-blind, placebo-controlled, 3-week study assessing the effects of colesevelam on pruritus. Colesevelam is an oral, non-absorbable bile-acid sequestrant much more potent than cholestyramine but free of adverse effects. It is registered as a lipid lowering agent. The intensity of symptoms will be scored by means of daily Visual Analogue Scales (VAS). Fatigue, quality of life and cutaneous scratch lesions will also be evaluated using quantitative instruments.
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 |
|---|---|---|
| 1 | Experimental | Drug: colesevelamVerum; colesevelam |
| 2 | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with pruritus as a result of a cholestatic disorder
- age above 18 years
- informed consent
Key exclusion criteria (4 listed)
- use of cholestyramine
- pregnancy
- inability to understand or speak Dutch language
- malignancy/life expectancy <6 months
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 |
|---|---|---|
| colesevelamAlso: Cholestagel2 times 3 625 mg tablets daily, 3 weeks | Drug | 1 |
| placebo2 times 3 625mg tablets daily | Drug | 2 |
Primary outcome
40% reduction of pruritus according to visual analogue scores
Time frame: 3 weeks
2 secondary outcomes
improvement in quality of life scores
Time frame: 3 weeks
Reduction in pruritus score/scratch lesions
Time frame: 3 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 18 Dec 2012.
- Derived from this study: PubMed 20683930Kuiper EM, van Erpecum KJ, Beuers U, Hansen BE, Thio HB, de Man RA, Janssen HL, van Buuren HR. The potent bile acid sequestrant colesevelam is not effective in cholestatic pruritus: results of a double-blind, randomized, placebo-controlled trial. Hepatology. 2010 Oct;52(4):1334-40. doi: 10.1002/hep.23821.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing colesevelam in people with Chronic Liver Disease, run by Foundation for Liver Research at 3 sites in Netherlands.
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 3 inclusion and 4 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 18 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
40% reduction of pruritus according to visual analogue scores (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 NCT00756171, which also lists 1 linked publication.
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 18 Dec 2012.