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New treatment option for Polycystic Liver Disease
Official title A GnRH Agonist IN Pre-menopausal Women STudy to Treat Severe Polycystic Liver Disease
ClinicalTrials.gov ID: NCT05478083
What this study is testing
What is Leuprorelin?
Leuprorelin is an investigational medicine, given as a monthly injectable medicine, being studied as a potential treatment for polycystic liver disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only
You may be able to join if
- 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...
- 18-30 yr; height adjusted TLV \> 2.0 L/m
You likely can't join if
- 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...
- 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...
See the full eligibility 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
- Since somatostatin analogues are proven efficacious therapy for polycystic liver disease at this time it is required that:
- patients use a somatostatin analogue and still have confirmed liver growth; OR
- patient have a specific reason not to use this medication, .e.g. patient used a somatostatin analogue in the past, but had to stop it due to inefficacy or because he/she did not tolerate it, patient has a...
- 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), 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 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 how well it works of safety...
- Participation in other treatment studies at the same time.
The study team makes the final eligibility decision.
Where it's taking place
- Nijmegen, Gelderland, Netherlands
- Groningen, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nijmegen, Gelderland, Netherlands; Groningen, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.