Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Everolimus and LongActing Octreotide Trial in Polycystic Livers (ELATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01157858
Recruitment Status : Completed
First Posted : July 7, 2010
Last Update Posted : June 29, 2015
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Joost Drenth, Radboud University

Tracking Information
First Submitted Date  ICMJE July 6, 2010
First Posted Date  ICMJE July 7, 2010
Last Update Posted Date June 29, 2015
Study Start Date  ICMJE June 2010
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2010)
Liver volume [ Time Frame: at baseline and at 12 months ]
change of total liver volume in terms of percentage from baseline to 12 months as determined by CT
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2010)
  • Symptoms [ Time Frame: baseline and 12 months ]
    Change in symptoms, measured by GI-questionnaire
  • Quality of Life [ Time Frame: baseline and 12 months ]
    Change in quality of life, measured by EuroQoL-questionnaire
  • Responders [ Time Frame: baseline and 12 months ]
    Proportion of patients having any reduction in total liver volume after 12 months
  • Adverse events [ Time Frame: During 12 months of treatment ]
    Adverse events that occur in these 12 months
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Everolimus and LongActing Octreotide Trial in Polycystic Livers
Official Title  ICMJE Everolimus Added to Long Acting Octreotide as a Volume Reducing Treatment of Polycystic Livers
Brief Summary The aim of this study is to reduce polycystic liver volume by treating with octreotide, whether or not combined with everolimus; to assess whether combination therapy of everolimus and octreotide gives a bigger reduction of polycystic liver volume than octreotide monotherapy.
Detailed Description

This is a single center randomized, open-label, parallel study comparing the safety and efficacy of everolimus-octreotide LAR treatment to monotherapy octreotide LAR in adult symptomatic patients with polycystic livers because of polycystic liver disease (PCLD).

We aim to include 44 patients affected by a polycystic liver either due to PCLD, 22 patients in the combination group and 22 patients in the mono therapy group.The duration of the trial will be 52 weeks. The treatment will be 48 weeks and the last control visit will take place four weeks after the treatment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Polycystic Liver Disease
Intervention  ICMJE
  • Drug: Everolimus
    2.5 mg every day orally
    Other Name: Afinitor
  • Drug: Octreotide LAR
    40 mg every 28 days IM
    Other Name: Sandostatine LAR
Study Arms  ICMJE
  • Active Comparator: Everolimus + octreotide LAR
    Octreotide LAR combined with everolimus
    Interventions:
    • Drug: Everolimus
    • Drug: Octreotide LAR
  • Active Comparator: Octreotide LAR
    Octreotide LAR monotherapy
    Intervention: Drug: Octreotide LAR
Publications * Chrispijn M, Drenth JP. Everolimus and long acting octreotide as a volume reducing treatment of polycystic livers (ELATE): study protocol for a randomized controlled trial. Trials. 2011 Nov 21;12:246. doi: 10.1186/1745-6215-12-246.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 6, 2010)
44
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 < age ≤ 70 years
  • Polycystic liver disease (PCLD), defined as ≥ 20 liver cysts
  • Total liver volume must be at least 2500 mL
  • Symptomatic defined as ECOG-PS ≥ 1 (see fig 3.1)38, and having at least three out of ten PCLD symptoms:
  • Abdominal pain
  • Abdominal distension
  • Abdominal fullness
  • Dyspnea
  • Early satiety
  • Back pain
  • Nausea/vomiting
  • Anorexia
  • Weight loss
  • Jaundice
  • Informed consent, patients are willing and able to comply with the study drug regimen and all other study requirements

Exclusion Criteria:

  • ADPKD patients
  • Use of oral anticonceptives or estrogen supplementation
  • Females who are pregnant or breast-feeding or patients of reproductive potential not employing an effective method of birth control. Women of childbearing potential must have a negative serum pregnancy test within 48 hours prior to the administration of study medication.
  • Intervention (aspiration or surgical intervention) within three months before baseline
  • Treatment with somatostatin analogues within three months before baseline
  • Patients with a kidney transplant
  • 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 (octreotide decreases gall bladder volume)
  • Hypercholesterolemia (fasting cholesterol > 8 mmol/l) or hypertriglyceridaemia (> 5 mmol/l) not controlled by lipid lowering therapy
  • Granulocytopenia (white blood cell < 3,000/mm3) or thrombocytopenia (platelets < 100,000/mm3)
  • Infection with hepatitis B, hepatitis C, HIV, TBC (in medical history)
  • Mental illness that interferes with the patient ability to comply with the protocol
  • Drug or alcohol abuse within one year of baseline
  • Co-medication with strong inhibitor of CYP3A4 and or P-gp like voriconazole, ketoconazole, diltiazem, verapamil, erythromycin or with a strong CYP3A4 and or P-gp inductor like rifampicin
  • Known hypersensitivity to everolimus or one of its excipients
  • Enrolment in another clinical trial of an investigational agent while participating in this study
  • Moderate or severe reaction on contrast in medical history
  • Treatment with I131 during the course of the trial
  • Use of metformin
  • Morbus Kahler or Morbus Waldenstrom with excretion of light chains in urine in medical history
  • Kidney dysfunction (MDRD-GFR < 60 ml/min/1.73m2 and ECC < 60 ml/min, calculated by the Cockcroft-Gault formula); in case of decreased body muscle mass, exact ECC is measured using serum and urine creatinine
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01157858
Other Study ID Numbers  ICMJE CSMS995 ANLIIT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joost Drenth, Radboud University
Study Sponsor  ICMJE Radboud University
Collaborators  ICMJE Novartis
Investigators  ICMJE
Principal Investigator: Joost PH Drenth, MD, PhD Radboud University
Study Director: Melissa Chrispijn, MD Radboud University
PRS Account Radboud University
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP