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

NCT06288334 | Recruiting Phase 4

• 1 other identifier: PUTH PD_V 1.2
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Allergic Disease; Children

Outcome Measures

Primary Outcomes (1)

• Plasma concentration

  0.5 ~ 48 hours before and after administration

Study Arms (1)

Pediatric patients treated with cetirizine

EXPERIMENTAL

Pediatric patients who were being treated with cetirizine to fight allergic diseases.

Other: 1-3 Cetirizine Pharmacokinetic samples

Interventions

1-3 Cetirizine Pharmacokinetic samples OTHER

Limited sampling strategy was used in this study. For each child, only 1\~3 blood samples were collected before and after cetirizine administration.

Pediatric patients treated with cetirizine

Eligibility Criteria

• Age: 6 Months - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).
• Pediatric patients, whether they are outpatients or inpatients, who require oral cetirizine therapy.
• The children was clinically diagnosed with allergic diseases such as eczema, urticaria, asthma, and allergic rhinitis.
• Pediatric patients had not taken other antiallergic drugs 72 hours before screening.

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Study Officials

• Wei Zhou

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongyang Liu

CONTACT

(86)010-82266658; liudongyang@vip.sina.com

Yafen Li

CONTACT

18222566785; liyafen314159@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: March 1, 2024
• Study Start: August 6, 2020
• Primary Completion: March 31, 2024
• Study Completion: May 31, 2024
• Last Updated: March 1, 2024

Record last verified: 2024-02

Locations

CN (1)