Phase 2 Study IV QUZYTTIR™ (Cetirizine Hydrochloride Injection) vs V Diphenhydramine

Overview

This study is designed to compare the incidence of infusion reactions to treatment with Rituxan® (rituximab) after premedication with intravenous (IV) QUZYTTIR™ cetirizine hydrochloride (HCl) or IV diphenhydramine during first-cycle infusion.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: July 2020

Detailed Description

This will be a randomized, double-blind exploratory study of IV cetirizine HCl 10 mg/mL versus IV diphenhydramine 50 mg/mL in approximately 34 patients who require premedication for hypersensitivity infusion reactions associated with Rituxan (rituximab).

The objectives and purpose of the study will be described to patients presenting at the participating infusion centers. The patients will be randomized to receive either IV cetirizine HCl or IV diphenhydramine.

Interventions

  • Drug: Cetirizine HCl 10 mg/mL
    • 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
  • Drug: Diphenhydramine 50 mg/mL
    • 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
  • Drug: Rituxan® (rituximab)
    • Compare the incidence of infusion reactions to treatment with Rituxan® (rituximab) after premedication with intravenous (IV) QUZYTTIR™ cetirizine hydrochloride (HCl) or IV diphenhydramine during first-cycle infusion.

Arms, Groups and Cohorts

  • Active Comparator: Cohort A
    • Cetirizine HCl 10 mg/mL: a single 1 mL injection.
  • Active Comparator: Cohort B
    • Diphenhydramine 50 mg/mL: a single 1 mL injection.

Clinical Trial Outcome Measures

Primary Measures

  • Hypersensitivity Reactions to Treatment
    • Time Frame: 1 Month
    • Compare the incidence 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 Rituxan® (rituximab) after premedication with intravenous (IV) QUZYTTIR™ cetirizine hydrochloride (HCl) or IV diphenhydramine during first-cycle infusion.(rituximab) with premedication of IV cetirizine HCl or IV diphenhydramine as a premedication. The infusion reactions will be evaluated following the Common Terminology Criteria for Adverse Events (CTCAE version 5.0) definitions of graded infusion reactions.

Participating in This Clinical Trial

Inclusion Criteria

  • Male or female patients who will receive treatment premedication with an antihistamine for hypersensitivity infusion reactions associated with Rituxan (rituximab)
  • 18 years of age or older

Exclusion Criteria

  • Receipt of an investigational drug or device within the past 30 days.
  • Patients with likelihood of developing or history of tumor lysis syndrome.
  • Patients in whom an antihistamine may be contraindicated (e.g., narrow angle glaucoma, symptomatic prostatic hypertrophy).
  • Patients who, in the opinion of the investigator, may not tolerate an IV injection of diphenhydramine 50 mg or cetirizine HCl 10 mg.
  • Receipt of any antihistamine (H1 antagonist) within the past 2 hours regardless of the route of administration, e.g., diphenhydramine, cetirizine, loratadine, fexofenadine, levocetirizine, desloratadine. chlorpheniramine, clemastine and doxylamine
  • Receipt of an H2 antagonist within the past 4 hours, e.g., ranitidine, cimetidine, famotidine, nizatidine.
  • Receipt of doxepin within the past 24 hours; doxepin is an antidepressant, but it also has antihistamine properties.
  • Receipt of epinephrine (EpiPen® or any other brand) within the past 30 days.
  • Has known allergy to hydroxyzine, cetirizine, or levocetirizine, or diphenhydramine.
  • Pregnant or breastfeeding.
  • Any condition that in the view of the investigator makes the patient unsuitable for enrollment in this study.
  • Major medical or psychiatric illness, other than diagnosed cancer at the time of presentation or in the past that in the investigators judgement they should not be enrolled in this clinical trial.
  • Inability to provide informed consent.
  • Patients on concomitant P-glycoprotein inhibitors

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • TerSera Therapeutics LLC
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Nancy Joseph-Ridge, M.D., 847-604-4058, njridge@tersera.com

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