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Table 1 Overview of in- and exclusion criteria for the AGAINST-PLD study

From: Protocol for a randomized controlled multicenter trial assessing the efficacy of leuprorelin for severe polycystic liver disease: the AGAINST-PLD study

Inclusion criteria

 

 Female

 

 Diagnosis of PLD (presence of > 10 cysts)

 

 Age 18–45 (inclusive) years

 

 Very large liver for age:

 

  18–30 y hTLV > 2.0 L/m

 

  30–35 y hTLV > 2.2 L/m

 

  25–40 y hTLV > 2.5 L/m

 

  40–45 y hTLV > 3.0 L/m

 

 1 historical MRI or CT scan of the liver available, made 5-1 y before baseline

 

 Ongoing liver growth, confirmed using the historical scan and MRI scan at screening

 

 Use of somatostatin analogues OR a reason not to use them (e.g. tried in de past but stopped because of side effects, not effective, no acces, patient does not want to)

 

 Voluntary written informed consent

 

Exclusion criteria

 

 Post menopausal status or (vasomotor) symptoms indicating upcoming menopause

 

 AMH < 0.03 ng/ml at screening

 

 Active desire to have children, pregnancy or breast-feeding

 

 Contra-indications for leuprorelin, such as cardiovascular disease or osteoporosis

 

 Liver transplantation expected within 1.5 years

 

 Use of oral estrogen or progesterone containing medication

 

 Contra-indications for MRI

 

 Chronic use of immunosupressive agents

 

 Severe hypertension (systolic pressure ≥ 160 and/or diastolic pressure ≥ 100 mmHg)

 

 Clinically significant uncontrolled medical condition that, in the opinion of the investigator, would put the safety of the patient at risk though participation, or which would affect efficacy or safety analysis, such as, but not limited to, recurrent cholangitis, recurrent ascites, hepato-venous outflow obstruction, (history of) depression

 

 Participation in other interventional studies at the same time

 

Exclusion criteria related to the historical MRI/CT scan

 

 Start or stop of liver volume reducing therapy (medication e.g. somatostain analogues or surgical interventions) between the historical scan and screening

 

 Historical scan is performed < 3 months after start or stop of volume reducing therapy (either a somatostatin analogue or surgical treatments)

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