Allergic DiseasePhase 4NCT06288334
Exploration of the Optimal Dosage of Cetirizine in the Treatment of Allergic Diseases in Chinese Children
A Phase 4 study testing 1-3 Cetirizine Pharmacokinetic samples in people with Allergic Disease and Children, run by Peking University Third Hospital at 1 site in China.
Trial summary
To obtain the pharmacokinetics of cetirizine in Chinese children with allergic disease. Read more about this study
- Who is it for?
- Ages 6 months to 16 years
- Conditions the study is for
- Allergic Disease, Children
- What is being tested?
- 1-3 Cetirizine Pharmacokinetic samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 6 Aug 2020to 31 May 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Yafen Li, 18222566785, liyafen314159@163.com
Wei Zhou
About this study
To obtain the pharmacokinetics of cetirizine in Chinese children with allergic disease.
- Conditions
- Allergic Disease, Children
- Being tested
- 1-3 Cetirizine Pharmacokinetic samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-3 Cetirizine Pharmacokinetic samplesOther
Limited sampling strategy was used in this study. For each child, only 1~3 blood samples were collected before and after cetirizine administration.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patients treated with cetirizine | Experimental | Pediatric patients who were being treated with cetirizine to fight allergic diseases. Receives: Other: 1-3 Cetirizine Pharmacokinetic samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration
Measured: 0.5 ~ 48 hours before and after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start6 Aug 2020
- Primary completion31 Mar 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic DiseaseStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongyang Liu, Peking University Third Hospital
- Investigators
- Wei Zhou, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288334
- Sponsor's protocol ID
- PUTH PD_V 1.2
- Status last verified
- Feb 2024
- First submitted
- 16 Feb 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the Optimal Dosage of Cetirizine in the Treatment of Allergic Diseases in Chinese Children
- ClinicalTrials.gov ID
- NCT06288334
- Acronym / sponsor ID
- PUTH PD_V 1.2
- Conditions
- Allergic Disease, Children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 6 Aug 2020 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To obtain the pharmacokinetics of cetirizine in Chinese children with allergic disease.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients treated with cetirizine | Experimental | Other: 1-3 Cetirizine Pharmacokinetic samplesPediatric patients who were being treated with cetirizine to fight allergic diseases. |
Who may qualify
- Ages
- 6 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1-3 Cetirizine Pharmacokinetic samplesLimited sampling strategy was used in this study. For each child, only 1~3 blood samples were collected before and after cetirizine administration. | Other | Pediatric patients treated with cetirizine |
Primary outcome
Plasma concentration
Time frame: 0.5 ~ 48 hours before and after administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Zhou principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 1-3 Cetirizine Pharmacokinetic samples in people with Allergic Disease and Children, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dongyang Liu ((86)010-82266658, liudongyang@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentration (time frame: 0.5 ~ 48 hours before and after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.