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Long-Term Safety and Efficacy of rFIXFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia B

NCT ID: NCT01425723

Last Updated: 2020-12-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-08

Study Completion Date

2017-10-31

Brief Summary

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The primary objective of the study is to evaluate the long-term safety of rFIXFc in participants with hemophilia B.

The secondary objective of this study is to evaluate the efficacy of rFIXFc in the prevention and treatment of bleeding episodes.

Detailed Description

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Participants will follow either a prophylaxis or on-demand regimen. The starting dose in this study will be determined by the clinical profile of the patient in the preceding studies, B-LONG 998HB102 (NCT01027364) and Kids B-LONG study 9HB02PED (NCT01440946)

Conditions

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Severe Hemophilia B

Keywords

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B-LONG B-YOND B-LONG Extension rFIXFc Severe Hemophilia B

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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On-Demand

The individual dose of rFIXFc to treat bleeding episodes will be based on participant's clinical condition, type and severity of the bleeding event, and if indicated, Factor IX peak (recovery) levels.

Group Type EXPERIMENTAL

rFIXFc

Intervention Type BIOLOGICAL

Administered as specified in the treatment arm.

Prophylaxis

Weekly prophylaxis, individualized prophylaxis or personalized prophylaxis available.

Group Type EXPERIMENTAL

rFIXFc

Intervention Type BIOLOGICAL

Administered as specified in the treatment arm.

Interventions

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rFIXFc

Administered as specified in the treatment arm.

Intervention Type BIOLOGICAL

Other Intervention Names

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coagulation factor IX (recombinant) Fc fusion protein Alprolix BIIB029

Eligibility Criteria

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Inclusion Criteria

* Subjects who have completed studies 998HB102 (NCT01027364) or 9HB02PED (NCT01440946) or other studies with rFIXFc
* Ability to understand the purposes \& risks of the study and provide signed and dated informed consent.

Exclusion Criteria

* High-titer inhibitor (\>/=5.00 BU/mL)
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Bioverativ Therapeutics Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Bioverativ Therapeutics Inc.

Locations

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Research Site

Phoenix, Arizona, United States

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Sacramento, California, United States

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Aurora, Colorado, United States

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Atlanta, Georgia, United States

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Honolulu, Hawaii, United States

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Indianapolis, Indiana, United States

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New Orleans, Louisiana, United States

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East Lansing, Michigan, United States

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Pittsburgh, Pennsylvania, United States

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Seattle, Washington, United States

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Adelaide, South Australia, Australia

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Parkville, Victoria, Australia

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Murdoch, Western Australia, Australia

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Perth, Western Australia, Australia

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Brussels, , Belgium

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Leuven, , Belgium

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Campinas, São Paulo, Brazil

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Beijing, Beijingshì, China

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Guangzhou, Guangdongsheng, China

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Shanghai, Shànghaishì, China

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Tianjing, Tianjinshì, China

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Marseille, Bouches-Du-Rhône, France

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Bonn, North Rhine-Westphalia, Germany

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Hong Kong, New Territories, Hong Kong

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Hong Kong, , Hong Kong

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Bangalore, Karnataka, India

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Pune, Maharashtra, India

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Vellore, Tamil Nadu, India

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Dublin, , Ireland

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Florence, , Italy

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Milan, , Italy

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Nagoya, Aichi-ken, Japan

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Kitakyushu, Fukuoka, Japan

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Kawasaki, Kanagawa, Japan

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Kashihara-shi, Nara, Japan

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Shinjuku-ku, Tokyo-To, Japan

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Tokyo, Tokyo-To, Japan

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Utrecht, , Netherlands

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Lodz, , Poland

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Johannesburg, Gauteng, South Africa

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Cape Town, Western Cape, South Africa

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Malmo, , Sweden

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Stockholm, , Sweden

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Cambridge, Cambridgeshire, United Kingdom

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London, Greater London, United Kingdom

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London, Greater London, United Kingdom

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Basingstoke, Hampshire, United Kingdom

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Countries

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Panama United States Australia Belgium Brazil Canada China France Germany Hong Kong India Ireland Italy Japan Netherlands Poland South Africa Sweden United Kingdom

References

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Astermark J, Hermans C, Ezzalfani M, Sidhom A, Barbier S, Kragh N, Falk A, Eriksson D. Recombinant factor IX Fc prophylaxis reduces pain and increases levels of physical activity, with sustained, long-term improvements in patients with hemophilia B: post hoc analysis of phase III trials using patient-reported outcomes. Ther Adv Hematol. 2023 May 29;14:20406207231170701. doi: 10.1177/20406207231170701. eCollection 2023.

Reference Type DERIVED
PMID: 37283819 (View on PubMed)

Shapiro AD, Kulkarni R, Ragni MV, Chambost H, Mahlangu J, Oldenburg J, Nolan B, Ozelo MC, Foster MC, Willemze A, Barnowski C, Jain N, Winding B, Dumont J, Lethagen S, Barnes C, Pasi KJ. Post hoc longitudinal assessment of the efficacy and safety of recombinant factor IX Fc fusion protein in hemophilia B. Blood Adv. 2023 Jul 11;7(13):3049-3057. doi: 10.1182/bloodadvances.2022009230.

Reference Type DERIVED
PMID: 36848635 (View on PubMed)

Shapiro AD, Pasi KJ, Ozelo MC, Kulkarni R, Barnowski C, Winding B, Szamosi J, Lethagen S. Extending recombinant factor IX Fc fusion protein dosing interval to 14 or more days in patients with hemophilia B. Res Pract Thromb Haemost. 2018 Nov 29;3(1):109-113. doi: 10.1002/rth2.12163. eCollection 2019 Jan.

Reference Type DERIVED
PMID: 30656283 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2011-003075-11

Identifier Type: -

Identifier Source: secondary_id

9HB01EXT

Identifier Type: -

Identifier Source: org_study_id