Polycystic Liver DiseasePhase 2/3LOCKCYSTNCT01315795
Lanreotide Autogel in the Treatment of Symptomatic Polycystic Liver Disease
A Phase 2/3 study testing Lanreotide Autogel 90 mg and 120 mg in people with Polycystic Liver Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
An open-label, Phase II clinical study to evaluate the efficacy and safety of lanreotide autogel 90mg every 4 weeks in the treatment of symptomatic polycystic liver disease, including a dose escalation at month 6 to lanreotide autogel 120mg for non responders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polycystic Liver Disease
- What is being tested?
- Lanreotide Autogel 90 mg and 120 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2011to Jul 2014
- 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
- Liver volume ≥ 4 liter
- ≥ 20 liver cysts
- Symptomatic patients defined as at least 2 out of 5 of the following symptoms related to mass effect irrespective of the intensity:
- Abdominal distention perceived as uncomfortable
- Frequent abdominal pain
- Early satiety
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- Nausea (with the inclusion of dyspeptic complaints)
- Dyspnea
- Diagnosed with ADPKD or ADPLD
- Male and female patients of 18 years and older
- Written informed consent
Who cannot join
- Creatinine clearance < 20 ml/min
- Patient who underwent a kidney transplant and received variable doses of immunosuppressive therapy and/or present signs of rejection in the past year
- Hormonal replacement therapy
- Hormonal contraception
- Pregnant or lactating
- Presenting with an uncontrolled disease (other than ADPKD/ADPLD)
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- Planned to undergo any surgery of the liver during study participation
- Planned to undergo any surgery of the KIDNEY during study participation (ADPKD patients only)
- Patients with known allergies to somatostatin or its analogues or any of its components
- Patients who received somatostatin analogues in the 6 months preceding study inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Phase II Clinical Study to Evaluate the Efficacy and Safety of Lanreotide Autogel 90mg Every 4 Weeks in the Treatment of Symptomatic Polycystic Liver Disease, Including a Dose Escalation at Month 6 to Lanreotide Autogel 120mg for Non Responders
An open-label, Phase II clinical study to evaluate the efficacy and safety of lanreotide autogel 90mg every 4 weeks in the treatment of symptomatic polycystic liver disease, including a dose escalation at month 6 to lanreotide autogel 120mg for non responders.
- Conditions
- Polycystic Liver Disease
- Being tested
- Lanreotide Autogel 90 mg and 120 mg
- Keywords
- polycystic liver disease
- Medical subject headings
- Polycystic liver disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lanreotide Autogel 90 mg and 120 mgDrug
administration of lanreotide sc every 4 weeks (28 days)
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic polycystic liver disease (PCLD) patients | Experimental | Symptomatic polycystic liver disease (PCLD) patients Receives: Drug: Lanreotide Autogel 90 mg and 120 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of total liver volume after 6 months of treatment measured by means of CT-scan.
Reduction of total liver volume after 6 months measured by means of CT-scan.
Measured: 6 months
Reduction of total liver volume after 12 months of treatment by means of CT-scan
Reduction of total liver volume after 12 months of treatment by means of CT-scan
Measured: 12 months
Reduction of total liver volume after 18 months of treatment by means of CT-scan
Reduction of total liver volume after 18 months of treatment by means of CT-scan
Measured: 18 months
Secondary outcomes (8)
Measurement of total liver and kidney volumes and cyst volumes at baseline.
Reduction of total liver volume Reduction of liver cyst volume Additonal reduction of total liver volume in the non responder group. Additonal reduction of liver cyst volume in the non responder group.
% of patients with liver reduction > 100 ml in the non responder group. Reduction of total kidney volume (ADPKD patients only) after 6 months, 1 year and 18 months
Measured: Baseline
Measurement of total liver and kidney volumes and cyst volumes after 6 months of treatment by means of CT scan
Reduction of total liver volume Reduction of liver cyst volume Additonal reduction of total liver volume in the non responder group. Additonal reduction of liver cyst volume in the non responder group.
% of patients with liver reduction > 100 ml in the non responder group. Reduction of total kidney volume (ADPKD patients only) after 6 months, 1 year and 18 months
Measured: 6 months
Measurement of total liver and kidney volume and cyst volume after 12 months of treatment by means of CT scan.
Reduction of total liver volume Reduction of liver cyst volume Additonal reduction of total liver volume in the non responder group. Additonal reduction of liver cyst volume in the non responder group.
% of patients with liver reduction > 100 ml in the non responder group. Reduction of total kidney volume (ADPKD patients only) after 6 months, 1 year and 18 months
Measured: 12 months
Measurement of total liver and kidney volumes and cyst volumes after 18 months of treatment by means of CT scan
Reduction of total liver volume Reduction of liver cyst volume Additonal reduction of total liver volume in the non responder group. Additonal reduction of liver cyst volume in the non responder group.
% of patients with liver reduction > 100 ml in the non responder group. Reduction of total kidney volume (ADPKD patients only) after 6 months, 1 year and 18 months
Measured: 18 months
Assessment of quality of life at baseline
Assessment of quality of life at baseline
Measured: baseline
Assessment of quality of life after 6 months of treatment
Assessment of quality of life after 6 months of treatment
Measured: 6 months
Assessment of quality of life after 12 months of treatment
Assessment of quality of life after 12 months of treatment
Measured: 12 months
Assessment of quality of life after 18 months of treatment
Assessment of quality of life after 18 months of treatment
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionJul 2014
- Study completionJul 2014
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 Polycystic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Ipsen
- Responsible party
- Principal investigator, Dr Frederik Temmerman, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Frederik Nevens, MD, PhD, Principal investigator, UZ Leuven, Gasthuisberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315795
- Sponsor's protocol ID
- 2010-024604-10
- Acronym
- LOCKCYST
- Status last verified
- Jul 2014
- First submitted
- 11 Jan 2011
- Last updated
- 8 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
van Keimpema L, Nevens F, Vanslembrouck R, van Oijen MG, Hoffmann AL, Dekker HM, de Man RA, Drenth JP. Lanreotide reduces the volume of polycystic liver: a randomized, double-blind, placebo-controlled trial. Gastroenterology. 2009 Nov;137(5):1661-8.e1-2. doi: 10.1053/j.gastro.2009.07.052. Epub 2009 Jul 29.
PubMed 19646443Temmerman F, Ho TA, Vanslembrouck R, Coudyzer W, Billen J, Dobbels F, van Pelt J, Bammens B, Pirson Y, Nevens F. Lanreotide Reduces Liver Volume, But Might Not Improve Muscle Wasting or Weight Loss, in Patients With Symptomatic Polycystic Liver Disease. Clin Gastroenterol Hepatol. 2015 Dec;13(13):2353-9.e1. doi: 10.1016/j.cgh.2015.05.039. Epub 2015 Jun 12.
PubMed 26073493
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase II Clinical Study to Evaluate the Efficacy and Safety of Lanreotide Autogel 90mg Every 4 Weeks in the Treatment of Symptomatic Polycystic Liver Disease, Including a Dose Escalation at Month 6 to Lanreotide Autogel 120mg for Non Responders
- ClinicalTrials.gov ID
- NCT01315795
- Acronym / sponsor ID
- LOCKCYST / 2010-024604-10
- Conditions
- Polycystic Liver Disease
- Keywords
- polycystic liver disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Ipsen
- Study start
- Mar 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 15 Mar 2011 (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.
An open-label, Phase II clinical study to evaluate the efficacy and safety of lanreotide autogel 90mg every 4 weeks in the treatment of symptomatic polycystic liver disease, including a dose escalation at month 6 to lanreotide autogel 120mg for non responders.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symptomatic polycystic liver disease (PCLD) patients | Experimental | Drug: Lanreotide Autogel 90 mg and 120 mgSymptomatic polycystic liver disease (PCLD) patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Liver volume ≥ 4 liter
- ≥ 20 liver cysts
- Symptomatic patients defined as at least 2 out of 5 of the following symptoms related to mass effect irrespective of the intensity:
- Diagnosed with ADPKD or ADPLD
- Male and female patients of 18 years and older
Key exclusion criteria (10 listed)
- Creatinine clearance < 20 ml/min
- Patient who underwent a kidney transplant and received variable doses of immunosuppressive therapy and/or present signs of rejection in the past year
- Hormonal replacement therapy
- Hormonal contraception
- Pregnant or lactating
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 |
|---|---|---|
| Lanreotide Autogel 90 mg and 120 mgadministration of lanreotide sc every 4 weeks (28 days) | Drug | Symptomatic polycystic liver disease (PCLD) patients |
Primary outcome
Reduction of total liver volume after 6 months of treatment measured by means of CT-scan.
Time frame: 6 months
Reduction of total liver volume after 6 months measured by means of CT-scan.
Reduction of total liver volume after 12 months of treatment by means of CT-scan
Time frame: 12 months
Reduction of total liver volume after 12 months of treatment by means of CT-scan
Reduction of total liver volume after 18 months of treatment by means of CT-scan
Time frame: 18 months
Reduction of total liver volume after 18 months of treatment by means of CT-scan
8 secondary outcomes
Measurement of total liver and kidney volumes and cyst volumes at baseline.
Time frame: Baseline
Measurement of total liver and kidney volumes and cyst volumes after 6 months of treatment by means of CT scan
Time frame: 6 months
Measurement of total liver and kidney volume and cyst volume after 12 months of treatment by means of CT scan.
Time frame: 12 months
Measurement of total liver and kidney volumes and cyst volumes after 18 months of treatment by means of CT scan
Time frame: 18 months
Assessment of quality of life at baseline
Time frame: baseline
Assessment of quality of life after 6 months of treatment
Time frame: 6 months
Assessment of quality of life after 12 months of treatment
Time frame: 12 months
Assessment of quality of life after 18 months of treatment
Time frame: 18 months
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 8 Jul 2014.
- Results publication: PubMed 19646443van Keimpema L, Nevens F, Vanslembrouck R, van Oijen MG, Hoffmann AL, Dekker HM, de Man RA, Drenth JP. Lanreotide reduces the volume of polycystic liver: a randomized, double-blind, placebo-controlled trial. Gastroenterology. 2009 Nov;137(5):1661-8.e1-2. doi: 10.1053/j.gastro.2009.07.052. Epub 2009 Jul 29.
- Derived from this study: PubMed 26073493Temmerman F, Ho TA, Vanslembrouck R, Coudyzer W, Billen J, Dobbels F, van Pelt J, Bammens B, Pirson Y, Nevens F. Lanreotide Reduces Liver Volume, But Might Not Improve Muscle Wasting or Weight Loss, in Patients With Symptomatic Polycystic Liver Disease. Clin Gastroenterol Hepatol. 2015 Dec;13(13):2353-9.e1. doi: 10.1016/j.cgh.2015.05.039. Epub 2015 Jun 12.
- Lanreotide reduces the volume of polycystic liver: a randomized, double-blind, placebo-controlled trial.Link provided by the sponsor.
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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.
Frederik Nevens, MD, PhD principal investigator
UZ Leuven, Gasthuisberg
1 site 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 Lanreotide Autogel 90 mg and 120 mg in people with Polycystic Liver Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 11 inclusion and 10 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 8 Jul 2014. 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 Belgium. 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.
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?
Reduction of total liver volume after 6 months of treatment measured by means of CT-scan. (time frame: 6 months). The study lists 3 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 NCT01315795, 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 Jul 2014.