Lanreotide Autogel in the Treatment of Symptomatic Polycystic Liver Disease (LOCKCYST)

Universitaire Ziekenhuizen KU Leuven

Status and phase

Completed

Phase 3

Phase 2

Conditions

Polycystic Liver Disease

Treatments

Drug: Lanreotide Autogel 90 mg and 120 mg

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01315795

2010-024604-10

Details and patient eligibility

About

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.

Enrollment

59 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)
- Dyspnea
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