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NCT02271165 · ClinicalTrials.gov registry record · Early Phase 1
Subcutaneous Immunoglobulin (Hizentra) in Patients With Dermatomyositis: A Proof of Concept Study
A Early Phase 1 study, sponsored by Thomas Jefferson University.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 2
- Enrollment target
NCT02271165 is a Early Phase 1 study that was terminated before completion, run by Thomas Jefferson University. The registered enrollment target is 2 participants.
The verdict
NCT02271165, a Early Phase 1 study, was terminated before completion, sponsored by Thomas Jefferson University.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the effectiveness and safety of human immunoglobulin SCIg in the form of Hizentra (Immune globulin Subcutaneous) in patients with Dermatomyositis. Hizentra provides effective protection against infection by maintaining a steady and normal level of immunoglobulin in the body) in patients with primary immunodeficiency. At present, patients with steroid resistant dermatomyositis can only be treated with IVIg (The healthy antibodies in IVIG can block the damaging antibodies that attack muscle and skin in dermatomyositis) treatment. An evaluation can then be made to see if SCIg is a suitable replacement and exerts immunomodulatory effect on complement antibodies.
Interventions
- DRUG Immunoglobulin (Hizentra)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2014-11 |
| Est. Completion | 2017-03-02 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02271165
The ClinicalTrials.gov registry entry for NCT02271165 describes a study currently listed as terminated, categorized as Early Phase 1. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Thomas Jefferson University, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Immunoglobulin (Hizentra) is the first listed.
NCT02271165 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02271165 about?
NCT02271165 is a clinical study titled "Subcutaneous Immunoglobulin (Hizentra) in Patients With Dermatomyositis: A Proof of Concept Study". The purpose of the study is to evaluate the effectiveness and safety of human immunoglobulin SCIg in the form of Hizentra (Immune globulin Subcutaneous) in patients with Dermatomyositis. Hizentra provides effective protection against infection by maintaining a steady and normal level of immunoglobul...
What is the current status of trial NCT02271165?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 2 participants. The study started on 2014-11. Estimated completion is 2017-03-02.
What interventions are being tested in trial NCT02271165?
The interventions under investigation include: Immunoglobulin (Hizentra) (DRUG).
Who is sponsoring clinical trial NCT02271165?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
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