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

All Individual Drugs Already Approved

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the 6 month visit

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

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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

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