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

PHASE2CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

March 25, 2020

Primary Completion Date

November 23, 2020

Study Completion Date

December 23, 2020

Conditions
Oncology Patients Receiving Chemotherapy
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

anti-CD20 such as Rituximab or Paclitaxel

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.

Trial Locations (7)

76508

Baylor, Scott, & White Medical Center, Temple

76712

Baylor, Scott, & White Medical Center, Waco

77030

Oncology Consultants, Houston

78665

Baylor, Scott, & White Medical Center, Round Rock

92270

Eisenhower Medical Center, Rancho Mirage

94558

St.Joseph Heritage Care, Napa

95403

St. Joseph Heritage Healthcare, Santa Rosa

All Listed Sponsors
lead

TerSera Therapeutics LLC

INDUSTRY

NCT04189588 - Phase 2 Study IV QUZYTTIR™ (Cetirizine Hydrochloride Injection) vs V Diphenhydramine | Biotech Hunter | Biotech Hunter