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Lanreotide Autogel in the Treatment of Symptomatic Polycystic Liver Disease
Plain-language guide to NCT01315795: phase 2, phase 3 interventional trial of Lanreotide, 59 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01315795
- Phase
- phase 2, phase 3
- Status
- completed
- Start
- 2011-03
- Completion (planned or actual)
- 2014-07
- Participants
- 59 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Polycystic Liver Disease
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 2, phase 3 trial tested Lanreotide.
It had 1 arm (groups): Symptomatic polycystic liver disease (PCLD) patients (experimental).
Symptomatic polycystic liver disease (PCLD) patients.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 59 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Liver volume ≥ 4 liter. ≥ 20 liver cysts. Symptomatic patients defined as at least 2 out of 5 of the following symptoms related to mass effect irrespective of the intensity:. Abdominal distention perceived as uncomfortable. Frequent abdominal pain.
The full record lists 11 inclusion and 10 exclusion criteria; among the exclusions: hormonal replacement therapy; hormonal contraception; pregnant or lactating.
How the Study Was Run
Design: single-group and open-label.
Nothing was hidden in this open-label Lanreotide study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2011-03 with completion listed for 2014-07.
It ran at 1 site in Belgium.
Its stated primary purpose is treatment.
What Was Measured
It also tracked 8 secondary outcomes, for example Measurement of total liver and kidney volumes and cyst volumes at baseline, Measurement of total liver and kidney volumes and cyst volumes after 6 months of treatment by means of CT scan, Measurement of total liver and kidney volume and cyst volume after 12 months of treatment by means of CT scan, Measurement of total liver and kidney volumes and cyst volumes after 18 months of treatment by means of CT scan, Assessment of quality of life at baseline and Assessment of quality of life after 6 months of treatment.
What This Means in Plain Language
Put simply, this is a phase 2, phase 3 trial of Lanreotide in 59 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Lanreotide compound page, all human trials.
Our Notes on the Compound
Lanreotide: A long-acting 8-amino-acid somatostatin analog (Somatuline Depot) in the same class as octreotide.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.