An Open-label, Phase II Clinical Study to Evaluate the Efficacy and Safety of Lanreotide Autogel 90mg Every 4 Weeks in the Treatment of Symptomatic Polycystic Liver Disease, Including a Dose Escalation at Month 6 to Lanreotide Autogel 120mg for Non Responders
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 59
- Locations
- 1
- Primary Endpoint
- Reduction of total liver volume after 6 months of treatment measured by means of CT-scan.
Study Overview
Brief Summary
An open-label, Phase II clinical study to evaluate the efficacy and safety of lanreotide autogel 90mg every 4 weeks in the treatment of symptomatic polycystic liver disease, including a dose escalation at month 6 to lanreotide autogel 120mg for non responders.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Liver volume ≥ 4 liter
- •≥ 20 liver cysts
- •Symptomatic patients defined as at least 2 out of 5 of the following symptoms related to mass effect irrespective of the intensity:
- •Abdominal distention perceived as uncomfortable
- •Frequent abdominal pain
- •Early satiety
- •Nausea (with the inclusion of dyspeptic complaints)
- •Diagnosed with ADPKD or ADPLD
- •Male and female patients of 18 years and older
- •Written informed consent
Exclusion Criteria
- •Creatinine clearance < 20 ml/min
- •Patient who underwent a kidney transplant and received variable doses of immunosuppressive therapy and/or present signs of rejection in the past year
- •Hormonal replacement therapy
- •Hormonal contraception
- •Pregnant or lactating
- •Presenting with an uncontrolled disease (other than ADPKD/ADPLD)
- •Planned to undergo any surgery of the liver during study participation
- •Planned to undergo any surgery of the KIDNEY during study participation (ADPKD patients only)
- •Patients with known allergies to somatostatin or its analogues or any of its components
- •Patients who received somatostatin analogues in the 6 months preceding study inclusion
Arms & Interventions
Symptomatic polycystic liver disease (PCLD) patients
Symptomatic polycystic liver disease (PCLD) patients
Intervention: Lanreotide Autogel 90 mg and 120 mg (Drug)
Outcomes
Primary Outcomes
Reduction of total liver volume after 6 months of treatment measured by means of CT-scan.
Time Frame: 6 months
Reduction of total liver volume after 6 months measured by means of CT-scan.
Reduction of total liver volume after 12 months of treatment by means of CT-scan
Time Frame: 12 months
Reduction of total liver volume after 12 months of treatment by means of CT-scan
Reduction of total liver volume after 18 months of treatment by means of CT-scan
Time Frame: 18 months
Reduction of total liver volume after 18 months of treatment by means of CT-scan
Secondary Outcomes
- Assessment of quality of life at baseline(baseline)
- Assessment of quality of life after 12 months of treatment(12 months)
- Assessment of quality of life after 18 months of treatment(18 months)
- Measurement of total liver and kidney volumes and cyst volumes at baseline.(Baseline)
- Measurement of total liver and kidney volume and cyst volume after 12 months of treatment by means of CT scan.(12 months)
- Measurement of total liver and kidney volumes and cyst volumes after 18 months of treatment by means of CT scan(18 months)
- Assessment of quality of life after 6 months of treatment(6 months)
- Measurement of total liver and kidney volumes and cyst volumes after 6 months of treatment by means of CT scan(6 months)
Investigators
Dr Frederik Temmerman
Professor Dr Frederik Nevens
Universitaire Ziekenhuizen KU Leuven