Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03730129 · ClinicalTrials.gov registry record · Phase 2
Humoral Immunodeficiency in CLL and Therapy With Subcutaneous Ig
A Phase 2 study of Secondary Immune Deficiency Disorder, sponsored by Rochester General Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT03730129 is a Phase 2 study of Secondary Immune Deficiency Disorder that has completed, run by Rochester General Hospital. The registered enrollment target is 20 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03730129, a Phase 2 study of Secondary Immune Deficiency Disorder, has completed, sponsored by Rochester General Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients with chronic lymphocytic leukemia (CLL) are at increased risk of infections as compared to age matched controls, with infections being a major cause of morbidity and mortality. Previous studies have shown that patients with CLL have both hypogammaglobinemia and impaired humoral immunity as defined by vaccine responses to both polysaccharide and peptide antigens. Attempts at decreasing infections in CLL have included therapy with prophylactic antibiotics and intravenous immunoglobulin. In general clinical practice and in previous studies, patients have started IV immunoglobulin replacement therapy if they have a history of serious infection or hypogammaglobinemia (defined as Immunoglobulin G below 500-600 g/dL), but vaccine responses have not been evaluated. This study will identify CLL patients with humoral immunodeficiency by checking both Ig levels and vaccines responses. In patients with impaired humoral immunity, the investigators will use subcutaneous immunoglobulin replacement to show this intervention will increase Ig levels, protective antibody titers, and be well tolerated.
Conditions Studied
Interventions
- DRUG Hizentra
Study Locations (1)
New York
- Allergy, Immunology, Rheumatology at Rochester Regional Health - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2018-11-05 |
| Est. Completion | 2020-07-03 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03730129
The ClinicalTrials.gov registry entry for NCT03730129 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rochester General Hospital, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Secondary Immune Deficiency Disorder appearing as the primary indexed condition, and to 1 intervention - of which Hizentra is the first listed.
NCT03730129 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT03730129 about?
NCT03730129 is a clinical study titled "Humoral Immunodeficiency in CLL and Therapy With Subcutaneous Ig". Patients with chronic lymphocytic leukemia (CLL) are at increased risk of infections as compared to age matched controls, with infections being a major cause of morbidity and mortality. Previous studies have shown that patients with CLL have both hypogammaglobinemia and impaired humoral immunity as ...
What is the current status of trial NCT03730129?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2018-11-05. Estimated completion is 2020-07-03.
What conditions does trial NCT03730129 study?
This clinical trial studies the following conditions: Secondary Immune Deficiency Disorder.
What interventions are being tested in trial NCT03730129?
The interventions under investigation include: Hizentra (DRUG).
Who is sponsoring clinical trial NCT03730129?
This trial is sponsored by Rochester General Hospital, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03730129 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.