Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00426153
Status:
COMPLETED
Last Update Posted:
2012-11-21
First Post:
2007-01-22
Brief Title:
Octreotide in Severe Polycystic Liver Disease
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Pilot Study Of Long-Acting Octreotide Octreotide LAR Depot In The Treatment Of Patients With Severe Polycystic Liver Disease
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the effect of Octreotide LAR on the liver volumes of patients with severe polycystic liver disease who are not candidates or decline surgical treatments such as liver cyst fenestration liver resection or liver transplantation A total of 42 patients will be recruited -14 who will receive placebo and 28 the study drug Preliminary evidence indicates that this drug is safe and non-toxic in other disease states Treatment with this drug holds promise not only for individuals with liver involvement but also for many more patients with polycystic kidney disease
Detailed Description:
The primary aim of this study is to compare the effect of Octreotide LAR Depot on the liver volume of patients with severe polycystic liver disease who are not candidates or decline surgical treatments such as liver cyst fenestration liver resection or liver transplantation compared with placebo The secondary aims of the study are 1Assess the effect of Octreotide LAR Depot on the total kidney volume and iothalamate clearance in patients with polycystic kidney disease associated with severe polycystic liver disease who are not candidates or decline surgical treatments such as liver cyst fenestration liver resection or liver transplantation 2Evaluate quality of life changes associated with the administration of Octreotide LAR Depot in these patients 3Assess toxicity of Octreotide LAR Depot in patients with polycystic liver disease PLD
Note Subjects who completed this 1 year randomized trial were offered enrollment into an open-label all subjects received Octreotide extension trial for an additional two years of treatment
Note Subjects who completed this 1 year randomized trial were offered enrollment into an open-label all subjects received Octreotide extension trial for an additional two years of treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UL1RR024150 | NIH | None | httpsreporternihgovquickSearchUL1RR024150 |