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Somatostatin analogues as a volume reducing treatment of polycystic livers

Somatostatin analogues as a volume reducing treatment of polycystic livers - SOLVE

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON32446
Enrollment
50
Registered
2010-01-11
Start date
2011-04-29
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

polycystic liver disease

Interventions

The patients will be randomized to either the octreotide or the lanreotide group and will receive every 28 days for 24 weeks octreotide 60 mg or lanreotide 120 mg, respectively.

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - patients with polycystic liver disease - 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

Exclusion criteria

Exclusion criteria: - kidney transplantation - renal failure requiring hemodialysis - use of oral contraceptives or estrogen suppletion - women who are pregnant or breastfeeding

Design outcomes

Primary

MeasureTime frame
Change in liver volume from baseline to 24 weeks.

Secondary

MeasureTime frame
Change in kidney volume from baseline to 24 weeks, change in symptoms from baseline to 24 weeks, change in quality of life from baseline to 24 weeks, proportion of patients that have any reduction of liver volume at 24 weeks, and adverse events during the 24 weeks.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)