NCT00716716

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2008

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

December 19, 2020

Status Verified

August 1, 2018

Enrollment Period

1.5 years

First QC Date

July 14, 2008

Last Update Submit

December 16, 2020

Conditions

Hemophilia B

Keywords

Hemophilia B severe, previously treated patients

Outcome Measures

Primary Outcomes (1)

  • Number of Participants experiencing Adverse Events

    Up to 45 days

Secondary Outcomes (10)

  • Time to reach maximum concentration (Tmax)

    Up to 45 days

  • Maximum concentration (Cmax)

    Up to 45 days

  • Half-life (t½)

    Up to 45 days

  • Clearance (CL)

    Up to 45 days

  • Volume of distribution (Vd)

    Up to 45 days

  • +5 more secondary outcomes

Study Arms (1)

rFIXFc

EXPERIMENTAL

Six intravenous (IV) dose levels, 1, 5, 12.5, 25, 50, and 100 IU/kg

Drug: rFIXFc

Interventions

rFIXFcDRUG

As specified in the treatment arm

Also known as: Alprolix, recombinant factor IX fusion protein, BIIB029, FIXFc
rFIXFc

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Are previously treated (PTPs) with severe (\<2 IU/dL endogenous FIX level) hemophilia B and at least 150 prior documented exposure days to other FIX products.
  • Have no prior history of or currently detectable inhibitor defined as \> 0.6 Bethesda units by the local lab. A family history of inhibitors will not exclude the patient.
  • No prior history of an allergic reaction or anaphylaxis associated with any FIX or IVIG administration.
  • No concurrent autoimmune disease.
  • At least 7 days since their last dose of FIX (wash-out period).
  • Certain laboratory testing criteria and other protocol-defined criteria may apply.
  • HIV negative or if HIV positive with a CD4 count ≥ 200 cells/mm3. HIV patients are allowed to receive protease inhibitors per the discretion of the Investigator.

You may not qualify if:

  • Presence of a major bleeding episode on Day 1 of study.
  • Any coagulation disorder in addition to hemophilia B.
  • A patient currently on a dose and regimen of FIX that would preclude participation in the study due to possible increased risk of bleeding because of the requirement to withhold treatment during the study period.
  • A positive d-dimer at screening.
  • Documented history of liver cirrhosis.
  • Positive for HBsAg and/or positive for hepatitis C antibody, and/or HIV positive with an ALT or AST greater than 5 times upper limit of normal.
  • Certain prior illnesses and other protocol-defined criteria.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

RUSH University Medical Center

Chicago, Illinois, 60612, United States

Location

Indiana Hemophilia & Thrombosis Center

Indianapolis, Indiana, 46260, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of North Carolina Medical School

Chapel Hill, North Carolina, 27599, United States

Location

Hemophilia Center of Western PA

Pittsburgh, Pennsylvania, 15213, United States

Location

Puget Sound Blood Center

Seattle, Washington, 98104, United States

Location

Related Publications (1)

  • Shapiro AD, Ragni MV, Valentino LA, Key NS, Josephson NC, Powell JS, Cheng G, Thompson AR, Goyal J, Tubridy KL, Peters RT, Dumont JA, Euwart D, Li L, Hallen B, Gozzi P, Bitonti AJ, Jiang H, Luk A, Pierce GF. Recombinant factor IX-Fc fusion protein (rFIXFc) demonstrates safety and prolonged activity in a phase 1/2a study in hemophilia B patients. Blood. 2012 Jan 19;119(3):666-72. doi: 10.1182/blood-2011-07-367003. Epub 2011 Nov 22.

    PMID: 22110246DERIVED

MeSH Terms

Conditions

Hemophilia B

Interventions

factor IX Fc fusion protein

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, X-Linked

Study Officials

  • Medical Director

    Bioverativ Therapeutics Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2008

First Posted

July 16, 2008

Study Start

April 1, 2008

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

December 19, 2020

Record last verified: 2018-08

Locations

US(6)