infantile hemangioma
Conditions
Interventions
Oral Propranolol Treatment Group:propranolol hydrochloride oral solution, 2mg/kg*d, twice a day
Sponsors
Beijing Children's Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
0.1 Years to 0.5 Years
Inclusion criteria
Inclusion criteria: 1.The guardian can understand and sign the informed consent voluntarily. 2.At the time of enrollment (day 1, D-1), the infants were 35 to 150 days old, and the infant weight was =2kg, regardless of gender. If the infant is a full-term child born at 37 to 42 weeks, it should be 35 to 150 days of age at enrollment. If the infant is premature, the correction age at enrollment should be 35 to 150 days old (correction age = weeks of birth - weeks of preterm birth). 3.High-risk infantile hemangiomas requiring systemic treatment or moderate-risk infantile hemangiomas requiring systemic treatment as determined by a physician: ?Life-threatening hemangioma: Beard-area IH, =5 cutaneous IHs. ?Function-threatening hemangioma: Periocular IH, IH involving lip or oral cavity. ?Hemangioma with a risk of Ulceration: Segmental IH, IH of any size involving any of the following sites: lips, columella, superior helix of ear, gluteal cleft and/or perineum, perianal skin, and other intertriginous areas (eg, neck, axillae, inguinal region). ?Associated structural anomalies: Segmental IH of face or scalp, may be associated with PHACE syndrome. Segmental IH of lumbosacral and/or perineal area, may be associated with LUMBAR syndrome. ?Hemangioma with a risk of disfigurement: Segmental IH, especially of face and scalp. Facial IH (=12 months of age), nasal tip or lip (any size) or any facial location =2 cm (>1 cm if =3 months of age).Scalp IH >2 cm. Neck, trunk, or extremity IH >2 cm, especially in growth phase or if abrupt transition from normal to affected skin (ie, ledge effect), thick superficial IH (eg, =2 mm thickness).Breast IH (female infants).
Exclusion criteria
Exclusion criteria: 1.After a thorough physical examination, vital signs, laboratory examination, etc., the investigator determined that the examination results were abnormal and clinically significant. 2.Patients suffer from one or more of the following diseases: asthma or bronchospasm, sinus node lesions (including sinus block), degree II or III atrioventricular block, decompensated heart failure, severe bradycardia, severe hypotension, cardiogenic shock, hypoglycemia, severe peripheral circulation disturbance (Reynolds' phenomenon), pheochromocytoma, coronary spasm risk, etc. 3.Patient who are allergic or known to be allergic to this product or excipients or any other beta-blocker. 4.Patient and/or Patient's mother (Breastfed patient) used the following drugs before initial dosing and within 5 elimination half-lives: Beta-blockers (prazosin), antidepressants (monoamine oxidase inhibitors or tricyclic antidepressants), non-steroidal anti-inflammatory drugs, glucocorticoids, substrates or inhibitors of CYP2D6 enzymes (e.g. Amiodarone, cimetidine, delavirdine, fluoxetine, paroxetine, Quinidine and ritonavir), substrates or inhibitors of CYP1A2 enzymes (e.g., imipramine, cimetidine, ciprofloxacin, Fluvoxamine, isoniazid, ritonavir, theophylline, zileuton, zolmitriptan, Rizatriptan, etc.), and substrates or inhibitors of CYP2C19 enzymes (e.g., fluconazole, cimetidine, fluoxetine, fluvoxamine, and tolbutamide, etc.), inducers of CYP450 enzyme (phenytoin, phenobarbital, rifampicin), other drugs (warfarin, propylamine phenylacetone, nifedipine, nisoldipine, nicardipine, pravastatin, lovastatin, zolmitriptan, rizatriptan, thioridazine, diazepam, 4-Methylimidazole, cholestyramine, colestipol, ethanol, propylamine phenylacetone, and aluminium hydroxide). 5.Patients who had been treated for infantile hemangioma prior to initial dosing, including any surgical or medical intervention (e.g., laser therapy) or medication (glucocorticoids, imiquimod 5%, vincristine, ?-interferon, propranolol, or other beta blockers). 6.Breastfed patient whose mother had taken beta-blockers (including propranolol) prior to the patient's initial dosing and whose dosing interval had not reached 5 elimination half-lives or whose mother must receive beta-blockers while the patient was being treated. 7.Patients who participated in any other clinical trial within 1 month prior to screening. 8.Patients who, in the opinion of the investigator, are not suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recovery rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Qualitative evaluation of efficacy;Hemangioma size;Hemangioma colour;Adverse events and Incidence; | — |
Countries
China
Contacts
Public ContactMa Llin
Beijing Children's Hospital, Capital Medical University
Outcome results
None listed