Open-Label Extension of LOCKCYST Trial

NCT ID: NCT00771888

Last Updated: 2008-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-08-31

Brief Summary

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Positive data originating from two polycystic liver patients treated with somatostatin analogues, showed a volume reduction of 38.3% and 14.9%. These two patients had complicated polycystic livers and no other therapeutic options were available.

Patients who participated in LOCKCYST trial are able to benefit from active treatment. Participants will be actively treated for 24 weeks.

Detailed Description

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van Keimpema L, de Man RA, Drenth JP. Somatostatin analogues reduce liver volume in polycystic liver disease. Gut 2008 September;57(9):1338-9.

Conditions

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Polycystic Liver Disease Hepatomegaly Liver Diseases Polycystic Kidney Autosomal Dominant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

lanreotide

Group Type OTHER

lanreotide

Intervention Type DRUG

lanreotide

Interventions

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lanreotide

lanreotide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participated in the LOCKCYST trial
* 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 (eg, NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases). In addition, patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled.
* 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 (lanreotide decreases gall bladder volume)
* Renal failure requiring hemodialysis
Minimum Eligible Age

18 Years

Maximum Eligible Age

88 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ipsen

INDUSTRY

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Radboud University Nijmegen Medical Center

Principal Investigators

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Joost PH Drenth, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Nijmegen Medical Center

Frederik Nevens, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Gasthuisberg, University of Leuven

Loes van Keimpema, MSc

Role: PRINCIPAL_INVESTIGATOR

Radboud University Nijmegen Medical Center

Locations

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University Hospital Gasthuisberg, University of Leuven

Leuven, , Belgium

Site Status

Radboud University Nijmegen Medical Center

Nijmegen, , Netherlands

Site Status

Countries

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Belgium Netherlands

References

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van Keimpema L, de Man RA, Drenth JP. Somatostatin analogues reduce liver volume in polycystic liver disease. Gut. 2008 Sep;57(9):1338-9. doi: 10.1136/gut.2008.155721. No abstract available.

Reference Type BACKGROUND
PMID: 18719151 (View on PubMed)

Other Identifiers

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NL16194.091.07

Identifier Type: -

Identifier Source: org_study_id