Trial Information
Long-Acting Lanreotide as a Volume Reducing Treatment of Polycystic Livers
Inclusion Criteria:
- 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
- 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
- Renal failure requiring hemodialysis
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Reduction of total liver volume as determined by CT scan
Outcome Time Frame:
6 months
Principal Investigator
Joost PH Drenth, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Radboud University Medical Center Nijmegen
Authority:
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study ID:
CMO 2007/010;ABR NL16194.091.0
NCT ID:
NCT00565097
Start Date:
October 2007
Completion Date:
Related Keywords:
- Polycystic Liver Disease
- Hepatomegaly
- Liver Diseases
- Polycystic Kidney, Autosomal Dominant
- Polycystic Liver Disease
- Autosomal Dominant Polycystic Kidney Disease
- Liver cyst
- Lanreotide
- Hepatomegaly
- Polycystic Kidney Diseases
- Liver Diseases
- Polycystic Kidney, Autosomal Dominant
- Cysts