LOCKCYST-ext: Open-Label Extension of LOCKCYST Trial

Sponsor

Radboud University Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT00771888

Collaborator

Ipsen (Industry)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Liver Disease Hepatomegaly Liver Diseases Polycystic Kidney Autosomal Dominant	Drug: lanreotide	Phase 2/Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

54 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2008

Actual Primary Completion Date :

Oct 1, 2008

Anticipated Study Completion Date :

Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Other: 1 lanreotide	Drug: lanreotide lanreotide

Arm

Intervention/Treatment

Other: 1

lanreotide

Drug: lanreotide

lanreotide

Outcome Measures

Primary Outcome Measures

Liver volume reduction [24 weeks]

Secondary Outcome Measures

Kidney volume Cyst volume [24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 88 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Gasthuisberg, University of Leuven	Leuven		Belgium
2	Radboud University Nijmegen Medical Center	Nijmegen		Netherlands	6500 HB

Sponsors and Collaborators

Radboud University Medical Center
Ipsen

Investigators

Principal Investigator: Joost PH Drenth, PhD, Radboud University Nijmegen Medical Center
Principal Investigator: Frederik Nevens, MD, PhD, University Hospital Gasthuisberg, University of Leuven
Principal Investigator: Loes van Keimpema, MSc, Radboud University Nijmegen Medical Center