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Safety Study of HemaMax™ (rHuIL-12) to Treat Acute Radiation Syndrome

NCT02343133 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2018-11-16

No results posted yet for this study

Summary

The purpose of this study is to determine whether HemaMax is safe and well tolerated to support efficacy under FDA's Animal Rule to reduce the morbidity and mortality associated with the hematopoietic syndrome of acute radiation syndrome.

Conditions

  • Hematopoietic Syndrome Due to Acute Radiation Syndrome

Interventions

BIOLOGICAL

HemaMax

DRUG

Placebo

Sponsors & Collaborators

Principal Investigators

  • Nicholas Siebers, MD · Covance Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT02343133 on ClinicalTrials.gov