A GnRH Agonist IN pre-menopausal women STudy to treat severe Polycystic Liver Disease
- Conditions
- Polycystic liver disease100198061001965410038430Cystic livers
- Registration Number
- NL-OMON50796
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 18
- 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)
o 18-30 yr; height adjusted TLV > 2.0 L/m
o 30-35 yr; height adjusted TLV > 2.2 L/m
o 35-40 yr; height adjusted TLV > 2.5 L/m
o 40-45 years; height adjusted TLV > 3.0 L/m
OR
Age independent hTLV > 2.0 L/m and PLD-Q score >30.
- With regard to the use of somatostatin analogues:
o patients use a somatostatin analogue and still have confirmed liver growth;
OR
o patient have a reason not to use this medication, .e.g. patient used a
somatostatin analogue in the past but had to stop due to inefficacy or because
he/she did not tolerate it, patient has a contra-indication for using
somatostatin analogues, patient or treating physician chose not to try
somatostatin analogues, no availability of somatostatin analogues
- Voluntary written informed consent before performance of any study-related
procedures not part of standard medical care, and able to read, comprehend,
and respond to study questionnaires.
- 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), unexplained vaginal bleeding, or a known
intolerance for leuprorelin
- Liver transplantation or liver surgery expected within 1.5 years, to the
discretion of the study doctor
- Use of hormonal oral contra-conception containing estrogen and/or
progesterone. In contrast, a hormone containing uterine device is not an
exclusion criteria.
- Contra-indications for both MRI and CT assessments (such as implants) or not
able or willing to undergo MRI and CT 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
- Therapy resistant 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome is the livergrowth, in percent per year, calculated from BL<br /><br>till t=1.5 years, compared between the direct start groep (receiving<br /><br>leuproreline treatment in this period) and the delayed start group (serving as<br /><br>a control group). </p><br>
- Secondary Outcome Measures
Name Time Method