Hemophilia BPhase 3NCT02053792
A Safety and Efficacy Extension Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B
A Phase 3 study testing rIX-FP in people with Hemophilia B, run by CSL Behring at 42 sites in 15 countries.
Trial summary
This study will examine the long-term safety and efficacy of rIX-FP for the control and prevention of bleeding episodes in children and adults with severe hemophilia B. The study will include subjects who have not previously been treated with Factor IX products, subjects who previously completed a CSL-sponsored rIX-FP… Read more about this study
- Who is it for?
- Ages Up to 70 years, men only
- Conditions the study is for
- Hemophilia B
- What is being tested?
- rIX-FP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 42 sitesin 15 countries
- Study dates
- 6 Feb 2014to 2 Jun 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 70 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Main study inclusion criteria:
- For previously treated subjects, either:
- Completed a CSL-sponsored rIX-FP (CSL654) study, including study CSL654_3001 [NCT01496274] or study CSL654_3002 [NCT01662531].
- Or:
- Scheduled to have a major non-emergency surgery within approximately 8 weeks from the anticipated date of receiving the first rIX-FP injection.
- Not previously completed a CSL-sponsored rIX-FP lead-in study.
Show all 21Show fewer
- Male, 12 to 70 years of age.
- Documented severe hemophilia B (FIX activity of ≤ 2%), or confirmed at screening by the central laboratory.
- Subjects who have received FIX products (plasma-derived and / or recombinant FIX) for > 150 exposure days (EDs), confirmed by their treating physician.
- No confirmed history of FIX inhibitor formation at screening by the central laboratory
- For previously untreated subjects:
- Male, up to 18 years of age.
- Documented severe hemophilia B (FIX activity of ≤ 2%), or confirmed at screening by the central laboratory.
- Never previously been treated with FIX clotting factor products (except previous exposure to blood components).
- No confirmed history of FIX inhibitor formation
- Surgery substudy inclusion criterion:
- Must require non-emergency surgery
- Subcutaneous substudy inclusion criteria:
- Male, at least 18 years of age.
- Subjects currently enrolled in Study CSL654_3003
- Subjects who have received rIX-FP for ≥ 100 EDs (single-dose cohorts) or for ≥ 50 EDs (repeated-dose cohort)
Who cannot join
- Main study exclusion criteria:
- Currently receiving a therapy not permitted during the study.
- Any issue that, in the opinion of the investigator, would render the subject unsuitable for participation in the study.
- For subjects who have previously completed a CSL-sponsored rIX-FP study:
- Unwilling to participate in the study for a total of 100 exposure days.
- For subjects requiring major non-emergency surgery who have not previously completed a CSL-sponsored rIX-FP lead-in study:
Show all 18Show fewer
- Known hypersensitivity (ie, allergic reaction or anaphylaxis) to any FIX product or hamster protein.
- Known congenital or acquired coagulation disorder other than congenital FIX deficiency.
- Currently receiving IV immunomodulating agents such as immunoglobulin or chronic systemic corticosteroid treatment.
- Low platelet count, kidney or liver disease.
- Human immunodeficiency virus positive with a CD4 count < 200/mm3.
- For previously untreated subjects:
- Known congenital or acquired coagulation disorder other than congenital FIX deficiency (except for vitamin K deficiency of the newborn).
- Known kidney or liver dysfunction or any condition which, in the investigator's opinion, place the patient at unjustifiable risk.
- The surgical substudy does not have any additional exclusion criteria, although subject(s) in France will not be eligible for the surgery sub-study.
- Subcutaneous substudy exclusion criteria:
- Intravenous use of rIX-FP within 14 days of subcutaneous administration of rIX-FP.
- Life-threatening bleeding episode or major surgery during the 3 months prior to substudy entry
Trial locations and contacts
42 sites in 15 countries.
42 sites in 15 countries
Germany7 sites
Institut fur experimentelle Hamatologie
Bonn, 53127
Prof. Hess Kinderklinik
Bremen, 28177
CRC Coagulation Research Centre GmbH
Duisburg, 47051
Heinrich Heine University Dusseldorf
Düsseldorf, 40225
Universtatsklinikum Hamburg-Eppendorf
Hamburg, 20246
Werlhof-Institute for Haemostasis and Thrombosis
Hanover, 30159
Kurpfalzkrankenhaus Heidlerberg GmbH
Heidelberg
Japan7 sites
Nara Medical University Hospital
Kashihara, 634-8522
University of Occupational and Environmental Health
Kitakyushu
Nagoya University Hospital
Nagoya, 466-8550
The Hospital of Hyogo College of Medicine
Nishinomiya
Tokyo Medical University Hospital
Tokyo, 160-0023
Ogikubo Hospital
Tokyo, 167-0035
St. Marianna University, School of Medicine, Seibu Hospital
Yokohama, 241-0811
France5 sites
CHRU Hopital Morvan
Brest, 29609
Hopital Louis Pradel
Bron, 69677
Hopital Bicetre - Centre de Traitement del'Hemophilia
Le Kremlin-Bicêtre, 94275
Hopital d'Enfants La Timonepital
Marseille, 13385
Hopital Necker-Enfants Malades
Paris, 75015
United States4 sites
University of Colorado
Aurora, Colorado, 80045
Indiana Hemophilia & Thrombosis Center Inc.
Indianapolis, Indiana, 46260
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Utah
Salt Lake City, Utah, 84103
Czechia3 sites
Fakultni nemocnice Brno
Brno, 62500
Fakultni Nemocrice Ostrava
Ostrava-Poruba, 708 52
Fakultni nemocnice v Motole
Prague, 15006
Italy3 sites
IRCCS Ospedale Maggiore[Centro emofilia e Trobosi]
Milan, 20122
UOS Gestione e Organizzazione Funzlone Hub Emofilia
Parma, 43126
Centro Malattie Emorragiche e Trombotiche Ospedale
Vicenza, 36100
Spain3 sites
C.H.U. A Coruna
A Coruña
Hospital Vall Hebron
Barcelona, 08035
H.U. La Paz
Madrid, 28046
Australia2 sites
Royal Children's Hospital
Parkville, Victoria, 3052
The Children's Hospital Westmead
Westmead, Victoria, 2145
Austria2 sites
Department of Pediatrics, Medical University of Vienna
Vienna, 1090
Medical University of Vienna, Vienna General Hospital
Vienna, 1090
Bulgaria1 site
SHAT "Joan Pavel" ODD [Hemorrhagic Diathesis & Anemia]
Sofia, 1233
About this study
Official title: A Phase 3b Open-label, Multicenter, Safety and Efficacy Extension Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) in Subjects With Hemophilia B
This study will examine the long-term safety and efficacy of rIX-FP for the control and prevention of bleeding episodes in children and adults with severe hemophilia B. The study will include subjects who have not previously been treated with Factor IX products, subjects who previously completed a CSL-sponsored rIX-FP lead-in study and subjects requiring major non-emergency surgery who have not previously completed a CSL-sponsored rIX-FP lead-in study.
A surgical prophylaxis substudy will examine the efficacy of rIX-FP in subjects with hemophilia B who are undergoing non-emergency major or minor surgery. An additional substudy will examine the safety and PK of subcutaneous (SC) administration of rIX-FP.
- Conditions
- Hemophilia B
- Being tested
- rIX-FP
- Medical subject headings
- Hemophilia B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rIX-FPBiological
Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP)
| Study group | Role | What they receive |
|---|---|---|
| rIX-FP | Experimental | Subjects will administer rIX-FP by intravenous infusion as routine prophylaxis, prevention, and on-demand treatment during a treatment period of approximately 3 years.
The routine prophylaxis treatment interval for previously treated patients may be changed at each scheduled 6-month follow-up assessment. On-demand treatment with rIX-FP will be used for all bleeding episodes requiring treatment. Subjects (other than those in France) may participate in a surgical 'substudy' in which rIX-FP may be administered before, during and after surgery. An additional substudy will examine the safety and PK of subcutaneous administration of rIX-FP.
For previously untreated patients, subjects will administer rIX-FP intravenously as weekly prophylaxis and/or on-demand treatment during the first 12 months, and as weekly routine prophylaxis thereafter.
The dose of rIX-FP administered will be based on the subject's previous rIX-FP use and/or pharmacokinetic data. Receives: Biological: rIX-FP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Participants Who Developed Inhibitors Against Factor IX (FIX)
Measured: For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs). For PUPs: up to 3 years or the time it takes to achieve 50 EDs.
Mean Incremental Recovery of a 50 IU/kg Dose of CSL654 in Previously Untreated Patients (PUPs)
Incremental Recovery: The increase in plasma concentration per IU/kg of factor administered.
Measured: Approximately 30 minutes after infusion of CSL654
Secondary outcomes (11)
Total Annualized Bleeding Rate (ABR) by Prophylaxis Regimen in Previously Treated Patients (PTPs)
Measured: For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs).
Spontaneous ABR by Prophylaxis Regimen in PTPs
Measured: For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs).
Average Amount of CSL654 (rIX-FP) Consumed Per Month Per Subject During Routine Prophylaxis Treatment.
Measured: For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs). For PUPs: up to 3 years or the time it takes to achieve 50 EDs.
Percentage of Participants With at Least One Treatment Emergent Adverse Event (TEAE) and the Percentage of Participants With at Least One CSL654-related TEAE
Measured: For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs). For PUPs: up to 3 years or the time it takes to achieve 50 EDs.
Number of Participants With Investigator's Overall Clinical Assessment of Hemostatic Efficacy for the Treatment of Major Bleeding Events With CSL654 in PUPs
The investigator will rate the efficacy of the rIX-FP treatment based on a hemostatic efficacy four point rating scale of excellent, good, moderate, or poor/no response.
Measured: Up to 3 years or the time it takes to achieve 50 EDs
Total ABR for On-demand Regimen vs. 14-Day Regimen in PTPs
Measured: For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs).
Spontaneous ABR for On-demand Regimen vs. 14-Day Regimen in PTPs
Measured: For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs).
Total ABR for Subjects >=12 Years: 7-Day Regimen vs. 14-Day Regimen in PTPs
Measured: For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs).
Spontaneous ABR for Subjects >=12 Years: 7-Day Regimen vs. 14-Day Regimen in PTPs
Measured: For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs).
Total ABR for Subjects >=12 Years: 7-Day Regimen vs. (10 or 14)-Day Regimen in PTPs
Measured: For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs).
Spontaneous ABR for Subjects >=12 Years: 7-Day Regimen vs. (10 or 14)-Day Regimen in PTPs
Measured: For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study start6 Feb 2014
- Primary completion2 Jun 2021
- Study completion2 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemophilia BStudies of the same condition, open and under way.
- More trials run by CSL BehringThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Program Director, Study director, CSL Behring
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02053792
- Sponsor's protocol ID
- CSL654_3003
- Other IDs
- 2012-005489-37
- Status last verified
- Jul 2022
- First submitted
- 29 Jan 2014
- Last updated
- 14 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Koopman SF, Cnossen MH, Mathot RAA; OPTI-CLOT study group and SYMPHONY consortium. Relationship between Dose, Factor IX Activity Levels and Bleeding Probability for rIX-FP Prophylaxis in Hemophilia B: A Repeated Time-to-Event Analysis. Clin Pharmacol Ther. 2025 Oct;118(4):831-840. doi: 10.1002/cpt.3724. Epub 2025 May 19.
PubMed 40386832
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b Open-label, Multicenter, Safety and Efficacy Extension Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) in Subjects With Hemophilia B
- ClinicalTrials.gov ID
- NCT02053792
- Acronym / sponsor ID
- CSL654_3003
- Conditions
- Hemophilia B
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2014 (actual)
- Primary completion
- 2 Jun 2021 (actual)
- Study completion
- 2 Jun 2021 (actual)
- First posted
- 4 Feb 2014 (estimated)
- Results
- Posted 14 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine the long-term safety and efficacy of rIX-FP for the control and prevention of bleeding episodes in children and adults with severe hemophilia B. The study will include subjects who have not previously been treated with Factor IX products, subjects who previously completed a CSL-sponsored rIX-FP lead-in study and subjects requiring major non-emergency surgery who have not previously completed a CSL-sponsored rIX-FP lead-in study.
A surgical prophylaxis substudy will examine the efficacy of rIX-FP in subjects with hemophilia B who are undergoing non-emergency major or minor surgery. An additional substudy will examine the safety and PK of subcutaneous (SC) administration of rIX-FP.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rIX-FP | Experimental | Biological: rIX-FPSubjects will administer rIX-FP by intravenous infusion as routine prophylaxis, prevention, and on-demand treatment during a treatment period of approximately 3 years. The routine prophylaxis treatment interval for previously treated patients may be changed at each scheduled 6-month follow-up assessment. On-demand treatment with rIX-FP will be used for all bleeding episodes requiring treatment. Subjects (other than those in France) may participate in a surgical 'substudy' in which rIX-FP may be administered before, during and after surgery. An additional substudy will examine the safety and PK of subcutaneous administration of rIX-FP. For previously untreated patients, subjects will administer rIX-FP intravenously as weekly prophylaxis and/or on-demand treatment during the first 12 months, and as weekly routine prophylaxis thereafter. The dose of rIX-FP administered will be based on the subject's previous rIX-FP use and/or pharmacokinetic data. |
Who may qualify
- Ages
- Up to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (21 listed)
- Completed a CSL-sponsored rIX-FP (CSL654) study, including study CSL654_3001 [NCT01496274] or study CSL654_3002 [NCT01662531].
- Scheduled to have a major non-emergency surgery within approximately 8 weeks from the anticipated date of receiving the first rIX-FP injection.
- Not previously completed a CSL-sponsored rIX-FP lead-in study.
- Male, 12 to 70 years of age.
- Documented severe hemophilia B (FIX activity of ≤ 2%), or confirmed at screening by the central laboratory.
Key exclusion criteria (18 listed)
- Currently receiving a therapy not permitted during the study.
- Any issue that, in the opinion of the investigator, would render the subject unsuitable for participation in the study.
- Unwilling to participate in the study for a total of 100 exposure days.
- For subjects requiring major non-emergency surgery who have not previously completed a CSL-sponsored rIX-FP lead-in study:
- Known hypersensitivity (ie, allergic reaction or anaphylaxis) to any FIX product or hamster protein.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rIX-FPRecombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) | Biological | rIX-FP |
Primary outcome
Total Number of Participants Who Developed Inhibitors Against Factor IX (FIX)
Time frame: For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs). For PUPs: up to 3 years or the time it takes to achieve 50 EDs.
Mean Incremental Recovery of a 50 IU/kg Dose of CSL654 in Previously Untreated Patients (PUPs)
Time frame: Approximately 30 minutes after infusion of CSL654
Incremental Recovery: The increase in plasma concentration per IU/kg of factor administered.
11 secondary outcomes
Total Annualized Bleeding Rate (ABR) by Prophylaxis Regimen in Previously Treated Patients (PTPs)
Time frame: For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs).
Spontaneous ABR by Prophylaxis Regimen in PTPs
Time frame: For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs).
Average Amount of CSL654 (rIX-FP) Consumed Per Month Per Subject During Routine Prophylaxis Treatment.
Time frame: For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs). For PUPs: up to 3 years or the time it takes to achieve 50 EDs.
Percentage of Participants With at Least One Treatment Emergent Adverse Event (TEAE) and the Percentage of Participants With at Least One CSL654-related TEAE
Time frame: For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs). For PUPs: up to 3 years or the time it takes to achieve 50 EDs.
Number of Participants With Investigator's Overall Clinical Assessment of Hemostatic Efficacy for the Treatment of Major Bleeding Events With CSL654 in PUPs
Time frame: Up to 3 years or the time it takes to achieve 50 EDs
Total ABR for On-demand Regimen vs. 14-Day Regimen in PTPs
Time frame: For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs).
Spontaneous ABR for On-demand Regimen vs. 14-Day Regimen in PTPs
Time frame: For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs).
Total ABR for Subjects >=12 Years: 7-Day Regimen vs. 14-Day Regimen in PTPs
Time frame: For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs).
Spontaneous ABR for Subjects >=12 Years: 7-Day Regimen vs. 14-Day Regimen in PTPs
Time frame: For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs).
Total ABR for Subjects >=12 Years: 7-Day Regimen vs. (10 or 14)-Day Regimen in PTPs
Time frame: For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs).
Spontaneous ABR for Subjects >=12 Years: 7-Day Regimen vs. (10 or 14)-Day Regimen in PTPs
Time frame: For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40386832Koopman SF, Cnossen MH, Mathot RAA; OPTI-CLOT study group and SYMPHONY consortium. Relationship between Dose, Factor IX Activity Levels and Bleeding Probability for rIX-FP Prophylaxis in Hemophilia B: A Repeated Time-to-Event Analysis. Clin Pharmacol Ther. 2025 Oct;118(4):831-840. doi: 10.1002/cpt.3724. Epub 2025 May 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Program Director study director
CSL Behring
42 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rIX-FP in people with Hemophilia B, run by CSL Behring at 42 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in Germany, Japan, France, United States, Czechia and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Number of Participants Who Developed Inhibitors Against Factor IX (FIX) (time frame: For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs). For PUPs: up to 3 years or the time it takes to achieve 50 EDs.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02053792, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2022.