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Study of Modified Recombinant Factor VIII (OBI-1) in Subjects With Congenital Hemophilia A

NCT01434511 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2021-05-14

Study results available
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Summary

This study is to test whether the study drug (OBI-1) is safe and effective for the treatment of serious bleeding episodes in people with congenital hemophilia A.

Conditions

Interventions

BIOLOGICAL

OBI-1

intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment

Sponsors & Collaborators

  • Baxalta now part of Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-03
Primary Completion
2013-07-29
Completion
2013-07-29

Countries

  • United States
  • South Africa
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT01434511 on ClinicalTrials.gov