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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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EUCTR |
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Last refreshed on:
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8 August 2022 |
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Main ID: |
EUCTR2009-017849-57-NL |
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Date of registration:
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13/01/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Somatostatin analogues as a volume reducing treatment of polycystic livers - SOLVE
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Scientific title:
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Somatostatin analogues as a volume reducing treatment of polycystic livers - SOLVE |
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Date of first enrolment:
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24/03/2011 |
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Target sample size:
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50 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-017849-57 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Netherlands
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
• Patients with ADPKD with polycystic liver (> 20 liver cysts)
• At least 18 years of age
• Informed consent, patients are willing and able to comply with the study drug regimen and all other study requirements
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
• Kidney transplantation
• Renal failure requiring hemodialysis
• Proteinuria of > 1g/L at baseline
• Use of oral contraceptives or estrogen suppletion
• Women who are pregnant or breastfeeding
• History of cardiac/pulmonary disease; symptomatic gallstones, etc
• Intervention (aspiration or surgical intervention) within three months before baseline
• Mental illness that interferes with the patient ability to comply with the protocol
• Drug or alcohol abuse within one year of baseline
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Polycystic liver disease, due to isolated polycystic liver disease or polycystic kidney disease.
MedDRA version: 12.1
Level: LLT
Classification code 10048834
Term: Polycystic liver disease
MedDRA version: 12.1
Level: PT
Classification code 10048834
Term: Polycystic liver disease
MedDRA version: 12.1
Level: LLT
Classification code 10036045
Term: Polycystic kidney
MedDRA version: 12.1
Level: LLT
Classification code 10036046
Term: Polycystic kidney, autosomal dominant
MedDRA version: 12.1
Level: LLT
Classification code 10036048
Term: Polycystic kidney, unspecified type
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Intervention(s)
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Product Name: Sandostatin LAR
Product Code: unknown
Pharmaceutical Form: Solution for injection
Product Name: Somatuline Autosolution
Product Code: unknown
Pharmaceutical Form: Solution for injection
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Primary Outcome(s)
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Main Objective: Reduction of liver volume
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Primary end point(s): reduction of liver volume
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Secondary Objective: Reduction of kidney volume, symptom evaluation, monitoring of kidney function
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 24/03/2011
Contact:
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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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