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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

GI Symptoms

Arthritis/pain and swelling in extremities

Epistaxis

Fever after discharge not attributed to KD

Fever following crossover treatment

Headache

URI

100%

80%

60%

40%

20%

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,590 Previous Clinical Trials

2,281,640 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

Recent research and studies

clinicaltrials.govStudy

Usage of Spirometry in Managing IgG Therapy in CVID With Airway Disease

Harry W. Schroeder, Jr., MD PhD 2024. "Usage of Spirometry in Managing IgG Therapy in CVID With Airway Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05193552.