Open-Label Extension of LOCKCYST Trial

Brief Title

Open-Label Extension of LOCKCYST Trial

Official Title

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

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.
    

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 Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

Liver volume reduction

Secondary Outcome

 Kidney volume Cyst volume

Condition

Polycystic Liver Disease

Intervention

lanreotide

Study Arms / Comparison Groups

 1
Description:  lanreotide

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

54

Start Date

April 2008

Completion Date

August 2009

Primary Completion Date

October 2008

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - 88 Years

Accepts Healthy Volunteers

No

Contacts

Joost PH Drenth, PhD, , 

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations


NCT ID

NCT00771888

Organization ID

NL16194.091.07



Study Sponsor

Radboud University

Collaborators

 Ipsen

Study Sponsor

Joost PH Drenth, PhD, Principal Investigator, Radboud University Nijmegen Medical Center


Verification Date

November 2008