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


Phase 2/Phase 3
18 Years
88 Years
Open (Enrolling)
Both
Polycystic Liver Disease, Hepatomegaly, Liver Diseases, Polycystic Kidney, Autosomal Dominant

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Liver volume reduction

Outcome Time Frame:

24 weeks

Safety Issue:

No

Principal Investigator

Joost PH Drenth, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Radboud University Nijmegen Medical Center

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

NL16194.091.07

NCT ID:

NCT00771888

Start Date:

April 2008

Completion Date:

August 2009

Related Keywords:

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

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