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

November 12, 2008 updated by: Radboud University Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium
        • University Hospital Gasthuisberg, University of Leuven
  • Netherlands
      • Nijmegen, Netherlands, 6500 HB
        • Radboud University Nijmegen Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Liver volume reduction
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Kidney volume Cyst volume
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Ipsen

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Anticipated)

August 1, 2009

Study Registration Dates

First Submitted

October 13, 2008

First Submitted That Met QC Criteria

October 14, 2008

First Posted (Estimate)

October 15, 2008

Study Record Updates

Last Update Posted (Estimate)

November 13, 2008

Last Update Submitted That Met QC Criteria

November 12, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL16194.091.07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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