Everolimus added to long acting octreotide as a volume reducing treatment of polycystic livers.

Phase 2

Completed

• Conditions: 10019654; polycystic liver disease

• Registration Number: NL-OMON32654
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 44

Inclusion Criteria

• 18 - 70 years of age
• Polycystic liver disease (PCLD), defined as >= 20 liver cysts and total liver volume must be at least 2500 mL.
• Informed consent, patients are willing and able to comply with the study drug regimen and all other study requirements.

Exclusion Criteria

- Use of estrogens
- Pregnancy or breastfeeding at baseline/during study
- Severe cardiac or pulmonary disease
- Intervention < 3 months before baseline
- Kidney transplantation
- Symptomatic gallstones
- Untreated hypercholesterolemie (fasting cholesterol > 8 mmol/L)
- Granulocytopenia (white blood cell < 3,000/mm3) or thrombocytopenia (platelets < 100,000/mm3)
- Infection with hepatitis B, hepatitis C, HIV or TBC
- Mental illness that interferes with ability to comply with study protocol
- Drug or alcohol abuse within one year before baseline
- Co-medication that interferes with study medication
- Hypersensitivity to everolimus or octreotide

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Reduction of liver volume from baseline to 48 weeks, as determined by CT scan.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Change in symptoms, as determined by GI symptom questionnaire, proportion of<br /><br>patients that have any reduction of liver volume after 48 weeks, and all<br /><br>adverse events during these 48 weeks.</p><br>