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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00771888 |
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Date of registration:
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13/10/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Open-Label Extension of LOCKCYST Trial
LOCKCYST-ext |
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Scientific title:
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Open-Label Extension of the LOCKCYST Trial, LOCKCYST: Long Acting Lnareotide as as Volume Reducing Treatment of Polycystic Livers |
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Date of first enrolment:
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April 2008 |
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Target sample size:
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54 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00771888 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Belgium
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Netherlands
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Contacts
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Name:
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Joost PH Drenth, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Radboud University Nijmegen Medical Center |
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Name:
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Loes van Keimpema, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Radboud University Nijmegen Medical Center |
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Name:
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Frederik Nevens, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital Gasthuisberg, University of Leuven |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Participated in the LOCKCYST trial
- 18 yrs-of age
- Multiple cysts > 20
- Cooperating patient
- Is willing and able to comply with the study drug regimen and all other study
requirements.
- Willingness to give written informed consent
Exclusion Criteria:
- Use of oral anticonceptives or estrogen suppletion
- Females who are pregnant or breast-feeding
- History or other evidence of chronic pulmonary disease associated with functional
limitation
- History of severe cardiac disease (eg, NYHA Functional Class III or IV, myocardial
infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment,
unstable angina or other significant cardiovascular diseases). In addition, patients
with documented or presumed coronary artery disease or cerebrovascular disease should
not be enrolled.
- History or other evidence of severe illness or any other conditions which would make
the patient, in the opinion of the investigator, unsuitable for the study
- Symptomatic gallstones (lanreotide decreases gall bladder volume)
- Renal failure requiring hemodialysis
Age minimum:
18 Years
Age maximum:
88 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hepatomegaly
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Polycystic Liver Disease
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Liver Diseases
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Polycystic Kidney
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Autosomal Dominant
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Intervention(s)
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Drug: lanreotide
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Primary Outcome(s)
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Liver volume reduction
[Time Frame: 24 weeks]
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Secondary Outcome(s)
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Kidney volume Cyst volume
[Time Frame: 24 weeks]
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Secondary ID(s)
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NL16194.091.07
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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