Overview

A Study to Evaluate Efficacy, Safety, and Pharmacokinetics of XEMBIFY® Plus Standard Medical Treatment (SMT) Compared to Placebo Plus SMT to Prevent Infections in Participants With Hypogammaglobulinemia and Recurrent or Severe Infections Associated

Status:
Not yet recruiting

Trial end date:
2026-06-01

Target enrollment:

Participant gender:

Summary

The primary purpose of the study is to evaluate whether weekly administered XEMBIFY® plus Standard Medical Treatment (SMT) over a one-year period will reduce the rate of major bacterial infections per participant per year in participants with hypogammaglobulinemia (HGG) associated with B-cell chronic lymphocytic leukemia (CLL) in comparison to the Placebo plus SMT group.

Phase:

Phase 3

Details

Lead Sponsor:

Grifols Therapeutics LLC

Treatments:

gamma-Globulins
Immunoglobulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin