efficacy of lanreotide LAR in controling total liver volume in patients with hepatic cysts as a result of ADPKD or PCLD
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Reduction of total liver volume as determined by multidetector CT scan (MDCT).
Secondary outcome
Reduction of liver volume and individual cyst volume on MDCT. Symptom
evaluation by validated questionnaire
Background summary
We have positive data originating from two polycystic liver patients treated
with somatostatin analogues. These two patients had complicated polycystic
livers and no other therapeutic options were available. The first patient was
treated for three months with octreotide: 10 days 50 mcg/hr i.v. and switched
to 100 mcg t.i.d. s.c. The second patient was treated for 6 months: 12 days
octreotide 100 mcg t.i.d. s.c. and switched to lanreotide 120 mg/month s.c.
Both patients improved clinically. Evaluation of the therapy by 3D-volumetry of
the polycystic livers demonstrated a volume reduction of 38.3% and 14.9%,
respectively.
Many patients who participated in the LOCKCYST trial have inquired about the
possibility of an open label extension. We feel that all patients should be
given the opportunity to benefit from active treatment. Therefore, patients
will be given the possibility to continue treatment open label for 6 months.
Entry to the open label is fully voluntary. Patients will be informed about the
possibility and the fact that the results of the LOCKCYST trial are still
unknown.
Study objective
efficacy of lanreotide LAR in controling total liver volume in patients with
hepatic cysts as a result of ADPKD or PCLD
Study design
A multicentre open label study.
Patients will receive 120 mg Lanreotide administered s.c. once every 4 weeks
(28 days). Therapy will be given monthly for a total period of 24 weeks, thus
yielding a total of 6 injections.
There will be a CT scan made (before made at the end of the LOCKCYST trial and)
after treatment.
Study burden and risks
So far, no medical treatment is available for polycystic liver disease. Until
now, various invasive surgical procedures such as laparoscopic fenestration,
hemihepatectomy and liver transplantation, are only for advanced cases and go
with considerable morbidity. Therefore, a medical alternative, such as
lanreotide is highly desirable.
Postbus 9101
6500 HB Nijmegen
Nederland
Postbus 9101
6500 HB Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
• 18 yrs-of age
• Multiple livercysts > 20 in PCLD- or ADPKD-patients
• Cooperating patient
• Is willing and able to comply with the study drug regimen and all other study requirements.
• Willingness to give written informed consent
Exclusion criteria
• Use of oral anticonceptives or estrogen suppletion
• Females who are pregnant or breast-feeding
• History or other evidence of chronic pulmonary disease associated with functional limitation
• History of severe cardiac disease (eg, NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases). In addition, patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled.
• History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
• Symptomatic gallstones (lanreotide decreases gall bladder volume)
• Renal failure requiring hemodialysis
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-002757-20-NL |
| CCMO | NL23299.091.08 |