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B Cell Induction in Pediatric Lung Transplantation

NCT02266888 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2021-10-26

Study results available
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Summary

In this study, doctors are trying to see if a study drug called rituximab (Rituxan®) will lower the number of B cells in the body. Doctors are also trying to see if decreasing B cells with rituximab (Rituxan®) can prevent injury to the transplanted lung. This treatment has been studied in other types of solid organ transplants.

Conditions

  • Lung Transplant

Interventions

BIOLOGICAL

Rituximab (Rituxan®)

2 Doses: 375 mg/m\^2 on Day 0 (within 12 hours of return to ICU following transplant) and Day 12 (+/-2 days).

BIOLOGICAL

Placebo

Placebo for Rituximab (Rituxan®). 2 Doses: 375 mg/m\^2 on Day 0 (within 12 hours of return to ICU following transplant) and Day 12 (+/-2 days).

Sponsors & Collaborators

  • Clinical Trials in Organ Transplantation in Children

    collaborator OTHER

  • Rho Federal Systems Division, Inc.

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Stuart Sweet, M.D., Ph.D. · Washington University Medical Center: Department of Pediatrics, Division of Allergy, Immunology and Pulmonary Medicine

  • Lara Danziger-Isakov, M.D., M.P.H. · Cincinnati Children's Hospital: Division of Infectious Diseases

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-22
Primary Completion
2019-06-30
Completion
2019-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02266888 on ClinicalTrials.gov