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A GnRH Agonist IN Pre-menopausal Women STudy to Treat Severe Polycystic Liver Disease | Clinical Trials | Clareo Health

RECRUITINGPHASE2

A GnRH Agonist IN Pre-menopausal Women STudy to Treat Severe Polycystic Liver Disease

NCT05478083•University Medical Center Groningen

Summary

Multicenter trial on the effect of the GnRH analogue leuprorelin on the growth of total liver volume in pre-menopausal women with very severe polycystic liver disease who, despite available therapy, experience growth and are heading for liver transplantation.

Eligibility

Age

18 - 45 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Female patients
•Diagnosis of polycystic liver disease defined as the presence of more than 10 liver cysts
•Age between 18 to 45 (inclusive) years;
•Very large liver for age, defined as the upper 10% of liver volumes in specific age categories (based on a retrospective polycystic liver disease registry, n=1.600 patients)
•* 18-30 yr; height adjusted TLV \> 2.0 L/m
•* 30-35 yr; height adjusted TLV \> 2.2 L/m
•* 35-40 yr; height adjusted TLV \> 2.5 L/m
•* 40-45 years; height adjusted TLV \> 3.0 L/m
•Availability of at least 1 historical MRI or CT scan made between 5 to 1 years before baseline visit of this study
•Ongoing liver growth, defined as an increase in absolute total liver volume between the historical MRI or CT scan and the MRI at screening of this trial
+4 more criteria

Exclusion Criteria

•Post-menopausal status or (vasomotor) symptoms indicating upcoming menopause
•Anti Mullerian Hormone (AMH) measurement at screening visit \<0.03 ng/ml.
•Active desire to have children, pregnancy or breast-feeding
•Contra-indications for leuprorelin, such as history of cardiovascular disease, history of osteoporosis or osteoporosis determined by DEXA-scan at screening (T score ≤ - 2.5), or a known intolerance for leuprorelin
•Liver transplantation or liver surgery expected within 1.5 years, to the discretion of the study doctor
•Contra-indications for MRI assessments (such as implants) or not able or willing to undergo MRI scan for other reasons (e.g. claustrophobia, profound obesity)
•Kidney transplantation or chronic use of immunosuppressive agents (such as cyclosporine, mycophenolic acid, tacrolimus but not prednisolone) for other indications
•Severe hypertension, defined as a systolic blood pressure \>160 mmHg and/or diastolic blood pressure \> 100 mm Hg.
•Clinically significant, uncontrolled medical condition that, in the opinion of the investigator, would put the safety of the patient at risk through participation, or which would affect the efficacy of safety analysis if the condition exacerbated during the study, or that may significantly interfere with study compliance, such as, but not restricted to, recurrent cholangitis, recurrent ascites or hepato-venous outflow obstruction, (history of) depression
•Participation in other interventional studies at the same time.

Locations (2)

Radboudumc

Nijmegen, Gelderland, Netherlands

Groningen universitair medical center

Groningen, Netherlands

Key Dates

Start Date

June 1, 2022

Primary Completion Date

June 1, 2027

Completion Date

October 1, 2027

Last Updated

November 4, 2022

Enrollment

ESTIMATED participants

Conditions

Polycystic Liver DiseaseAutosomal Dominant Polycystic Kidney

Interventions

Leuprorelin

DRUG

Contacts

Ron T Gansevoort

CONTACT

+31 50 3610923 r.t.gansevoort@umcg.nl

Renée Duijzer

CONTACT

renee.duijzer@radboudumc.nl

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 4, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A GnRH Agonist IN Pre-menopausal Women STudy to Treat Severe Polycystic Liver Disease

Inclusion Criteria

Exclusion Criteria

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