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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

Study Summary

This trial is researching the effects of Privigen on scleroderma patients' skin, with 24 participants at two hospitals. The goal is to help improve outcomes in this progressive disease.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Other outcome measures
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.

Find a Location

Who is running the clinical trial?

Georgetown UniversityLead Sponsor
343 Previous Clinical Trials
136,488 Total Patients Enrolled
CSL BehringIndustry Sponsor
195 Previous Clinical Trials
1,211,075 Total Patients Enrolled
Virginia D Steen, MDPrincipal InvestigatorGeorgetown University Hospital
1 Previous Clinical Trials
5 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
IVIG Treatment in Systemic Sclerosis
2013. "IVIG Treatment in Systemic Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01785056.
All > Scleroderma Research Foundation
~1 spots leftby May 2025
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