An international, multicenter, randomized controlled clinical trial assessing the efficacy of Ursodeoxycholic acid as a volume reducing treatment for symptomatic polycystic livers

An international, multicenter, randomized controlled clinical trial assessing the efficacy of Ursodeoxycholic acid as a volume reducing treatment for symptomatic polycystic livers - CURSOR

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38971

Enrollment

Registered

2013-08-07

Start date

2014-05-23

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

polycystic liver disease

Interventions

Intervention: The patients will be randomized (1:1) into two groups. One group of patients will receive 15-20mg/kg/day UDCA for 24 weeks. The other group will receive standard care.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • 18 = 20 liver cysts • Total liver volume >= 2500 mL ;• Symptomatic defined as ECOG-PS >= 1 (2), and having at least three out of ten PCLD symptoms: - Abdominal pain - Abdominal distension - Abdominal fullness - Dyspnea - Early satiety - Back pain - Nausea/vomiting - Anorexia - Weight loss - Jaundice • Informed consent, patients are willing and able to comply with the study drug regimen and all other study requirements.

Exclusion criteria

Exclusion criteria: • Use of oral anticonceptives or estrogen supplementation • Use of UDCA in 3 months before baseline • Females who are pregnant or breast-feeding or patients of reproductive potential not employing an effective method of birth control. • Intervention (aspiration or surgical intervention) within six months before baseline • Treatment with somatostatin analogues within months before baseline • Renal dysfunction (MDRD-GFR

Design outcomes

Primary

Measure	Time frame
Proportional change of total liver volume in UDCA treated patients versus non treated patients, as assessed by CT at baseline and 6 months.	—

Secondary

Measure	Time frame
Main secondary outcome variables: • To demonstrate whether UDCA-therapy changes absolute total liver volume • To demonstrate whether UDCA-therapy changes gastro-intestinal symptoms measured by a GI-questionnaire • To demonstrate whether UDCA-therapy changes quality of life as measured by SF-36 • To demonstrate which proportion of patients has any reduction in total liver volume after 24 weeks • To demonstrate whether UDCA is well tolerated • To demonstrate whether UDCA-therapy changes absolute total kidney volume (TKV).	—

Measure

Time frame

Main secondary outcome variables: • To demonstrate whether UDCA-therapy changes absolute total liver volume • To demonstrate whether UDCA-therapy changes gastro-intestinal symptoms measured by a GI-questionnaire • To demonstrate whether UDCA-therapy changes quality of life as measured by SF-36 • To demonstrate which proportion of patients has any reduction in total liver volume after 24 weeks • To demonstrate whether UDCA is well tolerated • To demonstrate whether UDCA-therapy changes absolute total kidney volume (TKV).

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)