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NCT04189588 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Study IV QUZYTTIR™ (Cetirizine Hydrochloride Injection) vs V Diphenhydramine
A Phase 2 study, sponsored by TerSera Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
NCT04189588: Completed Phase 2 study, sponsored by TerSera Therapeutics.
NCT04189588 is a Phase 2 study that has completed, run by TerSera Therapeutics. The registered enrollment target is 34 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04189588, a Phase 2 study, has completed, sponsored by TerSera Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
Study Summary
This study is designed to compare the number of infusion reactions to treatment with an anti-CD20 such as Rituxan® (rituximab) or Taxol® (Paclitaxel) after premedication with intravenous (IV) QUZYTTIR™ cetirizine hydrochloride (HCl) or IV diphenhydramine during first-cycle infusion or re-treatment with an anti-CD20 such as Rituxan® (rituximab) or Paclitaxel. Re-treatment is defined as re-treatment with an anti-CD20 such as Rituxan® (rituximab) or Paclitaxel after 6 months or in patients with persistent infusion reactions while on maintenance or retreatment.
Primary Outcome
Compare the number of patients experiencing any infusion reaction events, and the number and percentage of patients experiencing each symptom of infusion reactions (flushing, itching, alterations in heart rate and blood pressure, dyspnea, chest discomfort, acute back or abdominal pain, fever, shaking chills, nausea, vomiting, diarrhea, skin rashes, throat tightening, hypoxia, seizures, dizziness, or syncope) to treatment with anti-CD20 such as Rituxan® (rituximab) or Paclitaxel after premedicatio
Interventions
- DRUG Cetirizine HCl 10 mg/mL
- DRUG Diphenhydramine 50 mg/mL
- DRUG anti-CD20 such as Rituximab or Paclitaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2020-03-25 |
| Est. Completion | 2020-12-23 |
| Phase | Phase 2 |
What the finished NCT04189588 record still lists
NCT04189588 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 3 interventions - of which Cetirizine HCl 10 mg/mL is the first listed.
NCT04189588 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04189588 about?
NCT04189588 is a clinical study titled "Phase 2 Study IV QUZYTTIR™ (Cetirizine Hydrochloride Injection) vs V Diphenhydramine". This study is designed to compare the number of infusion reactions to treatment with an anti-CD20 such as Rituxan® (rituximab) or Taxol® (Paclitaxel) after premedication with intravenous (IV) QUZYTTIR™ cetirizine hydrochloride (HCl) or IV diphenhydramine during first-cycle infusion or re-treatment w...
What is the current status of trial NCT04189588?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2020-03-25. Estimated completion is 2020-12-23.
What interventions are being tested in trial NCT04189588?
The interventions under investigation include: Cetirizine HCl 10 mg/mL (DRUG), Diphenhydramine 50 mg/mL (DRUG), anti-CD20 such as Rituximab or Paclitaxel (DRUG).
Who is sponsoring clinical trial NCT04189588?
This trial is sponsored by TerSera Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04189588's enrollment target sits among peer trials
34 1539th of 2000 higher than 448 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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