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Efficacy and Safety Evaluation of Octreotide in the Treatment of Congenital Hyperinsulinemia (BCH)

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Capital Medical University

Status

Completed

Conditions

Octreotide Adverse Reaction
Congenital Hyperinsulinaemic Hypoglycaemia

Treatments

Drug: Octreotide Injection

Study type

Observational

Funder types

Other

Identifiers

NCT05171751
octreotide-CHI-2021

Details and patient eligibility

About

To analyze and evaluate the efficacy and safety of octreotide subcutaneous injection in the treatment of diazazine-ineffective congenital hyperinsulinemia (CHI) in children.

Full description

Octreotide subcutaneous injection is effective and safe in the treatment of congenital hyperinsulinemia in children with inefficacy of diazazine.

Enrollment

50 patients

Sex

All

Ages

1 month to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Consistent with the diagnosis of congenital hyperinsulinemia with ineffective diazine; With the maximum dose of diazine at 15mg/kg/d for 5 days, fasting blood glucose/postprandial blood glucose could not be stabilized at the target value of 3.3mmol/L without intravenous glucose infusion.
  2. patients treated with octreotide subcutaneous injection.

Exclusion criteria

  1. Before the diagnosis of CHI and the treatment related to CHI, the child had received total pancreatectomy without octreotide
  2. Secondary hypoglycemia caused by diseases other than CHI
  3. Patients who refused to take octreotide due to parents or family economic reasons, but not hospital treatment factors.
  4. Patients who intervene/interfere with octreotide treatment regimen for parental reasons

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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