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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: Completed Phase 2 study of Secondary Immune Deficiency Disorder, sponsored by Rochester General Hospital.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Incidence of humoral immunodeficiency
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 |
What the finished NCT03730129 record still lists
NCT03730129 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
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 a single indexed study location in 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
How this trial's enrollment target compares
Where NCT03730129's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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