CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
Rituximab (Rituxan®) +1 morebiological
Likely dose
Rituximab (Rituxan®) 375 mgfrom 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/NCT02266888
NCT02266888Phase 2Completed
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B Cell Targeted Induction to Improve Outcomes in Pediatric Lung Transplantation (CTOTC-08)

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Oct 17, 2014·Updated Oct 26, 2021

In Brief

A Phase 2 clinical trial evaluating Rituximab (Rituxan®) and Placebo for Lung Transplant. Completed, enrolled 45 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Transplant
CountriesUnited States
CollaboratorsClinical Trials in Organ Transplantation in Children, Rho Federal Systems Division, Inc.

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 17, 2014
Enrollment StartJan 22, 2015
Primary CompletionJun 30, 2019
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 11.7 years ago

Interventions

Rituximab (Rituxan®)biological

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

Placebobiological

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).