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Study of US-ATG-F to Prevent Chronic Graft Versus Host Disease (GVHD)

NCT01295710 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2019-04-09

Study results available
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Summary

The study objective is to compare the efficacy and safety of US-ATG-F as a supplement to standard of care prophylaxis versus standard of care prophylaxis alone in moderate to severe chronic GVHD-free survival.

Conditions

Interventions

BIOLOGICAL

US-ATG-F

20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation

BIOLOGICAL

Placebo

250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation

Sponsors & Collaborators

  • Neovii Biotech

    lead INDUSTRY

Principal Investigators

  • Anne Kuan · Neovii Biotech

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-10
Primary Completion
2015-10-15
Completion
2015-10-15

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01295710 on ClinicalTrials.gov