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Immunoglobulin Therapy

Treatment Group for Common Variable Immunodeficiency

Phase 4
Recruiting
Led By Harry Schroeder, MD/PhD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial aims to investigate the use of spirometry to determine if immunodeficiency patients on gammaglobulin replacement therapy could benefit from an increase in their treatment. The study will involve 22

Who is the study for?
This trial is for people with Common Variable Immunodeficiency (CVID) who've been on stable immunoglobulin replacement therapy (IGRT) for at least 3 months. They should have specific lung function test results showing mild to moderate obstruction. Preference is given to those already using Hizentra.Check my eligibility
What is being tested?
The study tests if using spirometry, a lung function test, can help adjust the dose of IGRT in CVID patients with airway disease. Half will continue their current IGRT dose; the other half will receive an increased dose of Hizentra for six months.See study design
What are the potential side effects?
Potential side effects from increasing Hizentra dosage could include headache, nausea, fatigue, injection site reactions or infections due to changes in immune system activity.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
FEF25-75% at 3 months
FEF25-75% at 6 months
FEF25-75% at baseline
+12 more
Secondary outcome measures
FACIT score at baseline and monthly on therapy
PADQOL-16 at baseline and monthly on therapy
St. George's Respiratory Questionnaire at baseline and monthly on therapy

Side effects data

From 2020 Phase 3 trial • 105 Patients • NCT03065244
45%
Continued Fever after treatment completion and crossover to other study treatment
20%
Hemolytic Anemia
10%
Rash
8%
GI Symptoms
8%
Arthritis/pain and swelling in extremities
6%
Epistaxis
6%
Fever after discharge not attributed to KD
6%
Fever following crossover treatment
4%
Headache
4%
URI
100%
80%
60%
40%
20%
0%
Study treatment Arm
IVIG
Infliximab

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment GroupExperimental Treatment1 Intervention
11 subjects will have their level of immunoglobulin replacement therapy increased by the equivalent of 0.05 gm/kg in dose per 4 weeks, adjusted for bioavailability as per manufacturer's instructions. On average, rounded up to the nearest gram, this will typically increase their dose of Hizentra by 2 gm per week.
Group II: Control GroupActive Control1 Intervention
11 subjects will be treated for 6 months at their current dose of Hizentra
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hizentra
2018
Completed Phase 3
~20

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,588 Previous Clinical Trials
2,280,290 Total Patients Enrolled
Harry Schroeder, MD/PhDPrincipal InvestigatorUniversity of Alabama at Birmingham

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the safety profile of the Treatment Group for individuals?

"As this intervention has been granted approval, our team at Power assesses the safety of the Treatment Group as a 3 on our scale."

Answered by AI

Are there any available vacancies for potential participants in this research study?

"As per clinicaltrials.gov, this investigation is actively pursuing eligible individuals. Initially published on January 15th, 2024, the study underwent its latest revision on February 29th of the same year."

Answered by AI

What is the current number of participants eligible for enrollment in this clinical research study?

"The information available on clinicaltrials.gov confirms the active recruitment status of this medical trial. Initially listed on 15th January 2024, and last modified on 29th February 2024, the study is seeking to enroll a total of 22 participants at one designated site."

Answered by AI
~15 spots leftby Dec 2025