Open-Label Extension of LOCKCYST Trial

Liver Diseases Clinical Trial

— LOCKCYST-ext  

Official title:

Open-Label Extension of the LOCKCYST Trial, LOCKCYST: Long Acting Lnareotide as as Volume Reducing Treatment of Polycystic Livers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00771888
• Other study ID #: NL16194.091.07
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: October 13, 2008
• Last updated: November 12, 2008
• Start date: April 2008
• Est. completion date: August 2009

Study information

• Verified date: November 2008
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 54
• Est. completion date: August 2009
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 88 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autosomal Dominant
• Cysts
• Hepatomegaly
• Liver Diseases
• Polycystic Kidney
• Polycystic Kidney Diseases
• Polycystic Liver Disease

Intervention

Drug:
• lanreotide
lanreotide

Locations

Country	Name	City	State
Belgium	University Hospital Gasthuisberg, University of Leuven	Leuven
Netherlands	Radboud University Nijmegen Medical Center	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Ipsen

Countries where clinical trial is conducted

Belgium,  Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver volume reduction		24 weeks	No
Secondary	Kidney volume Cyst volume		24 weeks	No

External Links

•   The website that informs on polycystic liver disease