Xembify
DrugSC infusion pump
Other names: Immune Globulin Subcutaneous (Human), 20% (IGSC 20%)
NCT Number: NCT05645107
The primary purpose of the study is to evaluate whether biweekly 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 B-cell CLL, MM, and NHL participants with hypogammaglobulinemia (HGG) in comparison to the Placebo plus SMT group.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
GC2202 Study Site 702, Banja Luka, Bosnia and Herzegovina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
SC infusion pump
Other names: Immune Globulin Subcutaneous (Human), 20% (IGSC 20%)
SC infusion pump
Other names: 0.9% Normal Saline
Time frame: Up to Week 51
Time frame: Up to Week 51
Time frame: Up to Week 51
Time frame: Up to Week 51
Time frame: Up to Week 51
Time frame: Up to Week 51
Time frame: Up to Week 51
Time frame: Up to Week 51
Time frame: Up to Week 51
Time frame: Up to Week 51
Time frame: Up to Week 51
Time frame: Up to Week 51
Time frame: Up to Week 51
Time frame: Up to Week 51
Contact information is provided by the study sponsor or research team.
Karen Pellath
CONTACT
Marina Acosta Enslen
CONTACT
Grifols Therapeutics LLC
Industry
A Randomized, Multi-Center, Parallel, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of XEMBIFY® Plus Standard Medical Treatment Compared to Placebo Plus Standard Medical Treatment to Prevent Infections in Patients With Hypogammaglobulinemia and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma
Acronym: EXCELL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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