At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 48 enrolled
Drug / intervention
Pasireotide LAR +1 moredrug
Likely dose
Pasireotide LAR 60mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Placebo Controlled Clinical Trial of SOM230 (Pasireotide LAR) In Severe Polycystic Liver Disease
In Brief
A Phase 2 clinical trial evaluating Pasireotide LAR and Placebo for Somatostatin Analogs and 3 related conditions. Completed, enrolled 48 participants across 1 site.
Detailed Summary
The purpose of this study is to compare SOM230 treatment to placebo. The investigators will also assess the efficacy and safety of SOM230 in reducing total liver volume and improving quality of life.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSomatostatin Analogs, Polycystic Liver Disease, Autosomal Dominant Polycystic Kidney Disease, Autosomal Dominant Polycystic Liver Disease
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2012
First PostedAug 2012
Primary CompletionSep 2018
TodayJul 2026
First PostedAug 21, 2012
Enrollment StartAug 1, 2012
Primary CompletionSep 1, 2018
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 13.9 years ago
Interventions
Pasireotide LARdrug
Injectible, 60mg per month
Placebodrug
To be injected once per month