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Study of Recombinant Factor IX Product, IB1001, in Previously Treated Subjects With Hemophilia B

NCT02048111 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2016-08-23

No results posted yet for this study

Summary

To evaluate the safety (acute adverse effects associated with infusions, and inhibitor development), pharmacokinetics (PK), and efficacy with respect to breakthrough bleeding and control of hemorrhaging during prophylaxis of IB1001 in subjects with hemophilia B.

Conditions

  • Hemophilia B

Interventions

BIOLOGICAL

IB1001

Prophylaxis (during Treatment and Continuation phases): 40 - 75 IU/kg twice weekly. The starting dose for prophylaxis may be based on previous recombinant factor IX product use. The recommended starting prophylaxis dose is 40 - 60 IU/kg twice weekly, however, the investigator may prescribe up to 75 IU/kg twice weekly at their discretion (after clinically assessing the subject) and discretion of the subject. The dose or the frequency of IB1001 prophylaxis may be adjusted at the discretion of the investigator.

Sponsors & Collaborators

  • Cangene Corporation

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-10-31
Completion
2015-11-30

Countries

  • United States
  • United Kingdom

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 NCT02048111 on ClinicalTrials.gov