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Open label extension of the LOCKCYST trial;LOCKCYST: Long-acting lanreotide as a volume reducing treatment of polycystic livers

Open label extension of the LOCKCYST trial;LOCKCYST: Long-acting lanreotide as a volume reducing treatment of polycystic livers - LOCKCYST trial extension

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON31937
Enrollment
30
Registered
2008-08-18
Start date
2008-06-01
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

polycystic liver disease

Interventions

None listed

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • 18 yrs-of age • Multiple livercysts > 20 in PCLD- or ADPKD-patients • 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

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

Design outcomes

Primary

MeasureTime frame
Reduction of total liver volume as determined by multidetector CT scan (MDCT).

Secondary

MeasureTime frame
Reduction of liver volume and individual cyst volume on MDCT. Symptom evaluation by validated questionnaire

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)