Open-Label Extension of LOCKCYST Trial

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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00771888

Acronym

LOCKCYST-ext

Enrollment

Registered

2008-10-15

Start date

2008-04-30

Completion date

2009-08-31

Last updated

2008-11-13

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

Conditions

Autosomal Dominant, Hepatomegaly, Liver Diseases, Polycystic Kidney, Polycystic Liver Disease

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.

Interventions

DRUGlanreotide

lanreotide

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 88 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Liver volume reduction	24 weeks

Secondary

Measure	Time frame
Kidney volume Cyst volume	24 weeks

Countries

Belgium, Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026