Open-Label Extension of LOCKCYST Trial (LOCKCYST-ext)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Radboud University.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Radboud University
Collaborator:
Ipsen
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00771888
First received: October 13, 2008
Last updated: November 12, 2008
Last verified: November 2008
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Purpose
Positive data originating from two polycystic liver patients treated with somatostatin analogues, showed a volume reduction of 38.3% and 14.9%. These two patients had complicated polycystic livers and no other therapeutic options were available.
Patients who participated in LOCKCYST trial are able to benefit from active treatment. Participants will be actively treated for 24 weeks.
| Condition | Intervention | Phase |
|---|---|---|
|
Polycystic Liver Disease Hepatomegaly Liver Diseases Polycystic Kidney Autosomal Dominant |
Drug: lanreotide |
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: | Open-Label Extension of the LOCKCYST Trial, LOCKCYST: Long Acting Lnareotide as as Volume Reducing Treatment of Polycystic Livers |
Resource links provided by NLM:
Genetics Home Reference related topics:
polycystic kidney disease
MedlinePlus related topics:
Liver Diseases
U.S. FDA Resources
Further study details as provided by Radboud University:
Primary Outcome Measures:
- Liver volume reduction [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Kidney volume Cyst volume [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 54 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | August 2009 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
lanreotide
|
Drug: lanreotide
lanreotide
|
Detailed Description:
van Keimpema L, de Man RA, Drenth JP. Somatostatin analogues reduce liver volume in polycystic liver disease. Gut 2008 September;57(9):1338-9.
Eligibility| Ages Eligible for Study: | 18 Years to 88 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Participated in the LOCKCYST trial
- 18 yrs-of age
- Multiple cysts > 20
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00771888
Locations
| Belgium | |
| University Hospital Gasthuisberg, University of Leuven | |
| Leuven, Belgium | |
| Netherlands | |
| Radboud University Nijmegen Medical Center | |
| Nijmegen, Netherlands, 6500 HB | |
Sponsors and Collaborators
Radboud University
Ipsen
Investigators
| Principal Investigator: | Joost PH Drenth, PhD | Radboud University Nijmegen Medical Center |
| Principal Investigator: | Frederik Nevens, MD, PhD | University Hospital Gasthuisberg, University of Leuven |
| Principal Investigator: | Loes van Keimpema, MSc | Radboud University Nijmegen Medical Center |
More Information
Additional Information:
Publications:
| Responsible Party: | Radboud University Nijmegen Medical Center |
| ClinicalTrials.gov Identifier: | NCT00771888 History of Changes |
| Other Study ID Numbers: | NL16194.091.07 |
| Study First Received: | October 13, 2008 |
| Last Updated: | November 12, 2008 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Netherlands: Medical Ethics Review Committee (METC) |
Additional relevant MeSH terms:
|
Hepatomegaly Polycystic Kidney Diseases Liver Diseases Cysts Digestive System Diseases Hypertrophy Pathological Conditions, Anatomical Kidney Diseases, Cystic Kidney Diseases |
Urologic Diseases Neoplasms Lanreotide Angiopeptin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 21, 2013