Open-Label Extension of LOCKCYST Trial (LOCKCYST-ext)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Radboud University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Ipsen
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00771888
First received: October 13, 2008
Last updated: November 12, 2008
Last verified: November 2008
  Purpose

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 Intervention Phase
Polycystic Liver Disease
Hepatomegaly
Liver Diseases
Polycystic Kidney
Autosomal Dominant
Drug: lanreotide
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Liver volume reduction [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Kidney volume Cyst volume [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 54
Study Start Date: April 2008
Estimated Study Completion Date: August 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
lanreotide
Drug: lanreotide
lanreotide

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.

  Eligibility

Ages Eligible for Study:   18 Years to 88 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771888

Locations
Belgium
University Hospital Gasthuisberg, University of Leuven
Leuven, Belgium
Netherlands
Radboud University Nijmegen Medical Center
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
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
  More Information

Additional Information:
Publications:
Responsible Party: Radboud University Nijmegen Medical Center
ClinicalTrials.gov Identifier: NCT00771888     History of Changes
Other Study ID Numbers: NL16194.091.07
Study First Received: October 13, 2008
Last Updated: November 12, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Medical Ethics Review Committee (METC)

Additional relevant MeSH terms:
Liver Diseases
Polycystic Kidney Diseases
Multicystic Dysplastic Kidney
Cysts
Hepatomegaly
Digestive System Diseases
Kidney Diseases, Cystic
Kidney Diseases
Urologic Diseases
Urogenital Abnormalities
Congenital Abnormalities
Neoplasms
Pathological Conditions, Anatomical
Hypertrophy
Lanreotide
Angiopeptin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Cardiovascular Agents

ClinicalTrials.gov processed this record on October 19, 2014