Track topics on Twitter Track topics that are important to you
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
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.
Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Pediatric Endocrinology Unit, Sheba Medical Center
Not yet recruiting
Sheba Medical Center
Published on BioPortfolio: 2014-08-27T03:15:49-0400
The purpose is to compare the efficacy and safety of lanreotide autogel® 60mg, 90mg or 120mg with lanreotide 40mg PR in subjects with active acromegaly.
This study aims to explore the efficacy and safety of lanreotide Autogel® 120 mg administered every 14 days in subjects with grade 1 or 2, metastatic or locally advanced, unresectable pan...
To evaluate the long-term efficacy and safety of repeated injections of lanreotide Autogel given in doses titrated to effect in acromegalic patients previously treated or not with somatost...
The main aim of this study is to assess the efficacy of the co-administration of lanreotide Autogel 120 mg (administered via deep sub-cutaneous injections every 28 days) and pegvisomant (a...
Congenital hyperinsulinism is a rare condition that can cause life-threatening hypoglycemia. Current treatment for congenital hyperinsulinism is often suboptimal, and such individuals may ...
Congenital hyperinsulinism is a rare disease, and the newly developed 18 fluoro--dihydroxyphenylalanine-positron emission tomography (18F-DOPA PET) examination can detect hyperplastic lesions. Our pur...
Congenital hyperinsulinism is the most common cause of persistent hypoglycemia in infants and children. Early and appropriate recognition and treatment of hypoglycemia is vital to minimize neurocognit...
A long-acting somatostatin analogue (lanreotide) is used in the management of a diazoxide-unresponsive diffuse form of congenital hyperinsulinism (CHI). However, no reports of its use in patients with...
Previous case reports have suggested a possible association of congenital hyperinsulinism with Turner syndrome.
To analyze clinical characteristics, genetic mutation and therapeutic effect of seven patients diagnosed with congenital hyperinsulinism(CHI).
A syndrome with excessively high INSULIN levels in the BLOOD. It may cause HYPOGLYCEMIA. Etiology of hyperinsulinism varies, including hypersecretion of a beta cell tumor (INSULINOMA); autoantibodies against insulin (INSULIN ANTIBODIES); defective insulin receptor (INSULIN RESISTANCE); or overuse of exogenous insulin or HYPOGLYCEMIC AGENTS.
A familial, nontransient HYPOGLYCEMIA with defects in negative feedback of GLUCOSE-regulated INSULIN release. Clinical phenotypes include HYPOGLYCEMIA; HYPERINSULINEMIA; SEIZURES; COMA; and often large BIRTH WEIGHT. Several sub-types exist with the most common, type 1, associated with mutations on an ATP-BINDING CASSETTE TRANSPORTERS (subfamily C, member 8).
A potent, long-acting synthetic SOMATOSTATIN octapeptide analog that inhibits secretion of GROWTH HORMONE and is used to treat hormone-secreting tumors; DIABETES MELLITUS; HYPOTENSION, ORTHOSTATIC; HYPERINSULINISM; hypergastrinemia; and small bowel fistula.
A benign tumor of the pancreatic ISLET CELLS. Usually it involves the INSULIN-producing PANCREATIC BETA CELLS, as in INSULINOMA, resulting in HYPERINSULINISM.
Congenital structural deformities of the upper and lower extremities collectively or unspecified.
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...