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Immunomodulator

Privigen for Systemic Sclerosis

N/A
Waitlist Available
Led By Virginia D Steen, MD
Research Sponsored by Georgetown University
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 at the 6 month visit
Awards & highlights

Summary

This trial is testing an antibody solution given through an IV in patients with scleroderma who haven't improved with standard treatments. The goal is to see if this treatment can help their immune system work better and reduce disease symptoms. The study will last for several months and involve a small group of patients.

Eligible Conditions
  • Systemic Sclerosis

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Other study objectives
Muscle, joint, and inflammatory parameters
To determine any toxicity of IVIG in scleroderma
To evaluate the effects of IVIG on pulmonary function
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: PrivigenExperimental Treatment1 Intervention
Privigen is a ready-to-use, sterile, 10% protein liquid preparation of polyvalent human immunoglobulin G (IgG) for intravenous administration. Subjects will be given 2 g/kg/month of IVIGfor 6 months. Each dose will be split into 2 to 4 infusions on consecutive days to achieve the total monthly dose.
Group II: Placebo (Albuminar-5)Placebo Group1 Intervention
Albuminar-5 is a sterile solution of albumin obtained from large pools of adult human venous plasma and used as the placebo in this study. Albuminar-5 will be administered by the intravenous route and each dose will be split into 2 to 4 infusions on consecutive days to achieve the total monthly dose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Human immunoglobulin G
FDA approved

Find a Location

Who is running the clinical trial?

Georgetown UniversityLead Sponsor
346 Previous Clinical Trials
137,196 Total Patients Enrolled
CSL BehringIndustry Sponsor
197 Previous Clinical Trials
1,211,352 Total Patients Enrolled
Virginia D Steen, MDPrincipal InvestigatorGeorgetown University Hospital
1 Previous Clinical Trials
5 Total Patients Enrolled
~1 spots leftby Sep 2025
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