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Immunoglobulin Replacement Therapy

SCIg Therapy for COPD

Phase 2
Recruiting
Led By Syed S Mustafa, MD
Research Sponsored by Rochester General Hospital
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 one year
Awards & highlights

Study Summary

This trial looks at the link between COPD and humoral immunodeficiency, and offers treatment with SCIgR to reduce future COPD flare ups.

Who is the study for?
Adults aged 18-82 with COPD who've had at least two severe flare-ups in the past year or one requiring hospitalization, despite being on triple therapy for over 90 days. They must be medically stable, not currently smoking, and without certain other health issues like severe liver or kidney disease, blood clotting disorders, or a history of organ transplant.Check my eligibility
What is being tested?
The trial is testing if Subcutaneous Immune Globulin Replacement Therapy (SCIgR) can reduce exacerbations in COPD patients with humoral immunodeficiency. It involves comparing SCIgR plus standard medical therapy against standard treatment alone to see which is more effective.See study design
What are the potential side effects?
Possible side effects of SCIgR include injection site reactions such as redness and swelling, headache, fatigue, nausea, fever and chills. Rarely it may cause systemic allergic reactions or worsen pre-existing heart conditions.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AECOPD requiring treatment with systemic steroids over one year
Secondary outcome measures
COPD with pre-defined humoral dysfunction treated with subcutaneous SCIgR will have decreased AECOPD events as compared to COPD with pre-defined humoral dysfunction treated with the standard of care (SOC) management.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group #1Experimental Treatment2 Interventions
SCIgR with Cuvitru 125 mg/kg/week + standard of care management
Group II: Group #2Placebo Group1 Intervention
Standard of care management = 20 patients

Find a Location

Who is running the clinical trial?

Rochester General HospitalLead Sponsor
13 Previous Clinical Trials
2,238 Total Patients Enrolled
TakedaIndustry Sponsor
1,203 Previous Clinical Trials
4,177,904 Total Patients Enrolled
Syed S Mustafa, MDPrincipal InvestigatorRochester General Hospital

Media Library

CUVITRU - Ig subcutaneous human 20% (Immunoglobulin Replacement Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05764993 — Phase 2
Chronic Obstructive Pulmonary Disease Research Study Groups: Group #1, Group #2
Chronic Obstructive Pulmonary Disease Clinical Trial 2023: CUVITRU - Ig subcutaneous human 20% Highlights & Side Effects. Trial Name: NCT05764993 — Phase 2
CUVITRU - Ig subcutaneous human 20% (Immunoglobulin Replacement Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05764993 — Phase 2
Chronic Obstructive Pulmonary Disease Patient Testimony for trial: Trial Name: NCT05764993 — Phase 2

Frequently Asked Questions

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

Is Group #1 a risk-free option for individuals?

"Due to the absence of evidence-based data that suggests Group #1's efficacy, its safety rating is 2 on a scale of 1 to 3."

Answered by AI

Are enrollments still occurring for this research endeavor?

"Contrary to what was expected, clinicaltrials.gov's records indicate that this medical study is not actively recruiting at the moment. Despite its original posting date of April 1st 2023 and latest update occurring on February 28th 2023, no new enrolments are being accepted currently. Nevertheless, 10 other trials remain in search for subjects right now."

Answered by AI

Who else is applying?

What state do they live in?
New York
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Rochester Regional Health - Ctr for Clinical Research - Linden Oaks
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I want to do anything I can to find improved COPD treatments and/or a cure for the disease.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Prevalence of Humoral Dysfunction in Pts With Frequent Exacerbations of COPD, and the Effect of SCIgR for Prevention
S. Shahzad Mustafa 2023. "Prevalence of Humoral Dysfunction in Pts With Frequent Exacerbations of COPD, and the Effect of SCIgR for Prevention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05764993.
~20 spots leftby Feb 2025
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