- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00771888
Open-Label Extension of LOCKCYST Trial (LOCKCYST-ext)
Open-Label Extension of the LOCKCYST Trial, LOCKCYST: Long Acting Lnareotide as as Volume Reducing Treatment of Polycystic Livers
Positive data originating from two polycystic liver patients treated with somatostatin analogues, showed a volume reduction of 38.3% and 14.9%. These two patients had complicated polycystic livers and no other therapeutic options were available.
Patients who participated in LOCKCYST trial are able to benefit from active treatment. Participants will be actively treated for 24 weeks.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Leuven, Belgium
- University Hospital Gasthuisberg, University of Leuven
-
-
-
-
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Nijmegen, Netherlands, 6500 HB
- Radboud University Nijmegen Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 1
lanreotide
|
lanreotide
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Liver volume reduction
Time Frame: 24 weeks
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Kidney volume Cyst volume
Time Frame: 24 weeks
|
24 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Frederik Nevens, MD, PhD, University Hospital Gasthuisberg, University of Leuven
- Principal Investigator: Joost PH Drenth, PhD, Radboud University Nijmegen Medical Center
- Principal Investigator: Loes van Keimpema, MSc, Radboud University Nijmegen Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Kidney Diseases
- Urologic Diseases
- Congenital Abnormalities
- Genetic Diseases, Inborn
- Pathological Conditions, Anatomical
- Abnormalities, Multiple
- Kidney Diseases, Cystic
- Ciliopathies
- Hypertrophy
- Liver Diseases
- Polycystic Kidney Diseases
- Hepatomegaly
- Antineoplastic Agents
- Lanreotide
Other Study ID Numbers
- NL16194.091.07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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