Exploration of the Optimal Dosage of Cetirizine in the Treatment of Allergic Diseases in Chinese Children

Phase 4

Recruiting

• Conditions: Children; Allergic Disease
• Interventions: Other: 1-3 Cetirizine Pharmacokinetic samples

• Registration Number: NCT06288334
• Lead Sponsor: Peking University Third Hospital

Brief Summary

To obtain the pharmacokinetics of cetirizine in Chinese children with allergic disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-06
• Status Verified: 2024-02
• Study First Submitted: 2024-02-16
• Study First Submitted QC: 2024-02-24
• Last Update Submitted: 2024-02-24
• Study First Posted: 2024-03-01
• Last Update Posted: 2024-03-01
• Primary Completion: 2024-03-31
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. The informed consent form was voluntarily signed by the legal guardians of the subjects (children aged ≥8 years should participate in the informed consent process and sign the informed consent form).
2. Pediatric patients, whether they are outpatients or inpatients, who require oral cetirizine therapy.
3. The children was clinically diagnosed with allergic diseases such as eczema, urticaria, asthma, and allergic rhinitis.
4. Pediatric patients had not taken other antiallergic drugs 72 hours before screening.

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Exclusion Criteria

1. Abnormal liver function (ALT or AST > 2 times the upper limit of normal).
2. Abnormal renal function (serum creatinine above the upper limit of normal or GFR < 10 mL/min)
3. Electrolyte abnormalities (potassium or magnesium < 0.8 times lower limit of normal, > 1.2 times upper limit of normal)
4. Children who were allergic to cetirizine or had a history of serious adverse reactions.
5. Pediatric patients with unstable vital signs.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pediatric patients treated with cetirizine	1-3 Cetirizine Pharmacokinetic samples	Pediatric patients who were being treated with cetirizine to fight allergic diseases.

Primary Outcome Measures

Name	Time	Method
Plasma concentration	0.5 ~ 48 hours before and after administration

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China