Lanreotide Autogel in the Treatment of Symptomatic Polycystic Liver Disease (LOCKCYST)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Polycystic Liver Disease |
Drug: Lanreotide Autogel 90 mg and 120 mg |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
- Reduction of total liver volume after 6 months of treatment measured by means of CT-scan. [ Time Frame: 6 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Reduction of total liver volume after 18 months of treatment by means of CT-scan
- Measurement of total liver and kidney volumes and cyst volumes at baseline. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Reduction of total liver volume Reduction of liver cyst volume Additonal reduction of total liver volume in the non responder group. Additonal reduction of liver cyst volume in the non responder group.
% of patients with liver reduction > 100 ml in the non responder group. Reduction of total kidney volume (ADPKD patients only) after 6 months, 1 year and 18 months
- Measurement of total liver and kidney volumes and cyst volumes after 6 months of treatment by means of CT scan [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Reduction of total liver volume Reduction of liver cyst volume Additonal reduction of total liver volume in the non responder group. Additonal reduction of liver cyst volume in the non responder group.
% of patients with liver reduction > 100 ml in the non responder group. Reduction of total kidney volume (ADPKD patients only) after 6 months, 1 year and 18 months
- Measurement of total liver and kidney volume and cyst volume after 12 months of treatment by means of CT scan. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Reduction of total liver volume Reduction of liver cyst volume Additonal reduction of total liver volume in the non responder group. Additonal reduction of liver cyst volume in the non responder group.
% of patients with liver reduction > 100 ml in the non responder group. Reduction of total kidney volume (ADPKD patients only) after 6 months, 1 year and 18 months
- Measurement of total liver and kidney volumes and cyst volumes after 18 months of treatment by means of CT scan [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Reduction of total liver volume Reduction of liver cyst volume Additonal reduction of total liver volume in the non responder group. Additonal reduction of liver cyst volume in the non responder group.
% of patients with liver reduction > 100 ml in the non responder group. Reduction of total kidney volume (ADPKD patients only) after 6 months, 1 year and 18 months
- Assessment of quality of life at baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]Assessment of quality of life at baseline
- Assessment of quality of life after 6 months of treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]Assessment of quality of life after 6 months of treatment
- Assessment of quality of life after 12 months of treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]Assessment of quality of life after 12 months of treatment
- Assessment of quality of life after 18 months of treatment [ Time Frame: 18 months ] [ Designated as safety issue: No ]Assessment of quality of life after 18 months of treatment
| Estimated Enrollment: | 62 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Symptomatic polycystic liver disease (PCLD) patients
Symptomatic polycystic liver disease (PCLD) patients
|
Drug: Lanreotide Autogel 90 mg and 120 mg
administration of lanreotide sc every 4 weeks (28 days)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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)
- 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
Contacts and Locations| Contact: Frederik Nevens, PhD, MD | +3216344299 | frederik.nevens@uzleuven.be |
| Contact: Frederik Temmerman, MD | +3216344299 | frederik.temmerman@uzleuven.be |
| Belgium | |
| UZ Leuven, Gasthuisberg | Recruiting |
| Leuven, Provincie Vlaams-Brabant, Belgium, 3000 | |
| Contact: Frederik Nevens, PhD, MD +3216344299 frederik.nevens@uzleuven.be | |
| Contact: Frederik Temmerman, MD +3216344299 frederik.temmerman@uzleuven.be | |
| Principal Investigator: Frederik Nevens, PhD, MD | |
| Principal Investigator: | Frederik Nevens, MD, PhD | UZ Leuven, Gasthuisberg |
More Information
Additional Information:
Publications:
| Responsible Party: | Professor Frederik Nevens, UZ Leuven, Gasthuisberg |
| ClinicalTrials.gov Identifier: | NCT01315795 History of Changes |
| Other Study ID Numbers: | 2010-024604-10 |
| Study First Received: | January 11, 2011 |
| Last Updated: | March 21, 2011 |
| Health Authority: | Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment |
Keywords provided by Universitaire Ziekenhuizen Leuven:
|
polycystic liver disease |
Additional relevant MeSH terms:
|
Liver Diseases Cysts Digestive System Diseases Neoplasms Pathological Conditions, Anatomical Lanreotide |
Angiopeptin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 22, 2013