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Exploratory Safety Study of ALD518 in Subjects With Steroid-refractory Acute Graft Versus Host Disease (GVHD)

NCT01530256 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2021-02-17

Study results available
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Summary

The purpose of this study is to determine the safe and tolerable, biologically active, and potentially effective doses(s) of ALD518 in subjects with acute GVHD, who have failed to respond to glucocorticosteroids, for further investigation in Part B.

Conditions

  • Acute GvHD

Interventions

BIOLOGICAL

ALD518

160 mg IV q 4 weeks for 4 doses

BIOLOGICAL

ALD518

320 mg IV q 4 weeks for 4 doses

BIOLOGICAL

ALD518

640 mg IV q 4 weeks for 2 doses

Sponsors & Collaborators

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Javier San Martin, MD FRCP · Alder Biopharmaceuticals, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01530256 on ClinicalTrials.gov