CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 34 enrolled
Drug / intervention
Cetirizine HCl 10 mg/mL +2 moredrug
Likely dose
Cetirizine HCl 10 mg/mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04189588
NCT04189588Phase 2Completed
CompareCT.gov

A Phase 2 Exploratory Study of Intravenous QUZYTTIR™ (Cetirizine Hydrochloride Injection) Versus Intravenous Diphenhydramine in the Prevention of Hypersensitivity Infusion Reactions

TerSera Therapeutics LLC·interventional·Posted Dec 6, 2019·Updated Oct 6, 2023

In Brief

A Phase 2 clinical trial evaluating Cetirizine HCl 10 mg/mL, Diphenhydramine 50 mg/mL, and 1 other intervention for Oncology Patients Receiving Chemotherapy. Completed, enrolled 34 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOncology Patients Receiving Chemotherapy
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedDec 6, 2019
Enrollment StartMar 25, 2020
Primary CompletionNov 23, 2020
Study CompletionDec 23, 2020
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 6.6 years ago

Interventions

Cetirizine HCl 10 mg/mLdrug

Comparison of two injectable products: cetirizine HCl 10 mg/mL and diphenhydramine 50 mg/mL, both administered during a 1 to 2-minute period by IV push using a 1 mL syringe

Diphenhydramine 50 mg/mLdrug

Comparison of two injectable products: cetirizine HCl 10 mg/mL and diphenhydramine 50 mg/mL, both administered during a 1 to 2-minute period by IV push using a 1 mL syringe

anti-CD20 such as Rituximab or Paclitaxeldrug

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. Re-treatment is defined as re-treatment with Rituxan® (Rituximab) or Paclitaxel after 6 months in patients with persistent infusion reactions while on maintenance or re-treatment.