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Phase I/IIa Study of FIXFc in Hemophilia B Patients

NCT00716716 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-12-19

No results posted yet for this study

Summary

The primary objective of the study is to assess safety of FIXFc at doses ranging from 1 to 100 IU/kg.

Conditions

  • Hemophilia B

Interventions

DRUG

rFIXFc

As specified in the treatment arm

Sponsors & Collaborators

  • Syntonix Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Swedish Orphan Biovitrum

    collaborator INDUSTRY

  • Bioverativ Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Bioverativ Therapeutics Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-10-31
Completion
2009-10-31

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 NCT00716716 on ClinicalTrials.gov