Trial record 3 of 11 for:    "Persistent Hyperinsulinemia Hypoglycemia of Infancy" OR "familial hyperinsulinism"

Lanreotide Autogel Treatment of Patients With Congenital Hyperinsulinism of Infancy

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Dr. Dalit Modan, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01070758
First received: February 17, 2010
Last updated: December 12, 2012
Last verified: December 2012
  Purpose

The purpose of our study is to evaluate the efficacy and safety of Lanreotide Autogel in children with congenital hyperinsulinism already treated with Octreotide by pump.

Congenital hyperinsulinism is a genetic disorder characterized by inappropriate insulin secretion resulting in persistent hypoglycemia (low blood sugars. Patients exposed to recurrent hypoglycemic episodes are at increased risk of developmental disorders, so identification and prompt management of patients are essential. Many patients are treated with the somatostatin analog Octreotide which is administered by continuous infusion using a pump (we use an insulin pump). This treatment may pose a huge burden and be stressful for patients and families as it demands intensive daily care. In an effort to simplify the daily care of our patients and improve their quality of life we will study the efficacy and safety of Lanreotide Autogel - a long-acting somatostatin analog that can be administered by injection once a month


Condition Intervention Phase
Congenital Hyperinsulinism
Drug: Lanreotide autogel
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment With Lanreotide Autogel (Somatostatin Analogue) in Patients With Congenital Hyperinsulinism of Infancy Already Treated With Somatostatin Analog by Pump

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Euglycemia as recorded by Continuous Glucose Monitoring System (CGMS) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: February 2010
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Lanreotide autogel
    The dose of Lan-ATG will be calculated according to the surface area of the patient. The dose used in adults is usually 60 mg injection once a month, and we will adapt the patient's dose according to the body surface area and also according to the daily dose of Octreotide used with the pump. The starting dose will be 40 mg/m².
    Other Name: Somatuline autogel
Detailed Description:

The purpose of our study is to evaluate the efficacy and safety of Lanreotide Autogel in children with CHI already treated with Octreotide by pump.

Patients and methods. Congenital hyperinsulinism (CH) is a genetic disorder characterized by dysregulated insulin secretion resulting in persistent hypoglycemia. Identification and prompt management of patients are essential, as patients exposed to recurrent hypoglycemic episodes are at increased risk of developmental disorders. Many patients are treated with the somatostatin analog Octreotide which is administered by continuous infusion using a pump. This treatment may pose a huge burden and be stressful for patients and families as it demands intensive daily care. In an effort to simplify the daily care of our patients and improve their quality of life we will study the efficacy and safety of Lanreotide Autogel(Lan-ATG)- a long-acting somatostatin analog that can be administered by injection once a month.

This trial will include children with CH, who are treated with Octreotide by pump. We believe that children older than 2 years old will benefit most from this therapy. At this age, some of the parents encounter technical problems with the pump, as the children are prone to play with the pump and take out the needles. It's also very difficult to place the children in day care, because they need continuous follow up.

The dose of Lan-ATG will be calculated according to the surface area of the patient. The dose used in adults is usually 60 mg and we will adapt the patient's dose according to the body surface area and also according to the daily dose of Octreotide used with the pump. The starting dose will be 40 mg/m².

The patients will be gradually weaned from the pump following the first injection of Lan-ATG (10% decrease every 3-4 days for a total of a month).

Every patient will serve as his/her own control.

The following examinations will be done in every child:

  1. Continuous blood glucose monitoring during 72 hours with a glucosensor, to exclude asymptomatic hypoglycemia - once in 6 months.
  2. Growth velocity every 3 months.
  3. Bone age once a year.
  4. Routine laboratory tests (biochemistry, CBC and thyroid function tests) every six months.
  5. Biliary US once in 6 months. During the follow up we will try to expand the distance between injections, based on our knowledge that most of the patients with CH are known to enter remission after the age of 4-5 years.
  Eligibility

Ages Eligible for Study:   2 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 2-8 years,
  • Diagnosed with congenital hyperinsulinism,
  • Treated by Octreotide continuous infusion (pump).

Exclusion Criteria:

  • Family not interested in participating.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01070758

Contacts
Contact: Dalit Modan, M.D. +972-3-5305015 dmodan@sheba.health.gov.il
Contact: Kineret Mazor, M.D. +972-3-5305015 Kineret.Mazor@sheba.health.gov.il

Locations
Israel
Pediatric Endocrinology Unit, Sheba Medical Center Recruiting
Tel-Hashomer, Ramat-Gan, Israel, 52653
Contact: Dalit Modan, M.D.    +972-3-5345410    dmodan@sheba.health.gov.il   
Principal Investigator: Dalit Modan, M.D.         
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Dalit Modan, M.D. Sheba Medical Ceter, Tel-Hashomer, Israel
  More Information

No publications provided by Sheba Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Dalit Modan, Pediatric Endocrinologist, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01070758     History of Changes
Other Study ID Numbers: SHEBA-10-7165-DM-CTIL
Study First Received: February 17, 2010
Last Updated: December 12, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Sheba Medical Center:
Congenital hyperinsulinism
Somatostatin analog
Lanreotide autogel
Hypoglycemia

Additional relevant MeSH terms:
Persistent Hyperinsulinemia Hypoglycemia of Infancy
Hyperinsulinism
Nesidioblastosis
Glucose Metabolism Disorders
Metabolic Diseases
Infant, Newborn, Diseases
Hypoglycemia
Pancreatic Diseases
Digestive System Diseases
Somatostatin
Lanreotide
Angiopeptin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 22, 2014