| CTRI Number |
CTRI/2012/05/002708 [Registered on: 30/05/2012] Trial Registered Prospectively |
| Last Modified On: |
24/08/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
To study the Long-Term Safety and Efficacy of Recombinant Human Coagulation Factor IX Fusion Protein (rFIXFc)in Haemophilia B patients. |
|
Scientific Title of Study
|
An Open-Label, Multicenter Evaluation of the Long-Term Safety and Efficacy of Recombinant Human Coagulation Factor IX Fusion Protein (rFIXFc) in the Prevention and Treatment of Bleeding Episodes in Previously Treated Subjects With Haemophilia B |
| Trial Acronym |
B-YOND |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT01425723 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Ritika Bajaj |
| Designation |
Associate Director |
| Affiliation |
Biogen |
| Address |
Flat 902, Tower -18. The close South , Nirvana country , Sector-50, Gurgaon , Haryana -122002
Gurgaon
HARYANA
122002
India |
| Phone |
9717004620 |
| Fax |
|
| Email |
ritika.bajaj@biogen.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Ritika Bajaj |
| Designation |
Associate Director |
| Affiliation |
Biogen |
| Address |
Flat 902, Tower -18. The close South , Nirvana country , Sector-50, Gurgaon , Haryana -122002
Gurgaon
HARYANA
122002
India |
| Phone |
9717004620 |
| Fax |
|
| Email |
ritika.bajaj@biogen.com |
|
Details of Contact Person
Public Query
|
| Name |
Ritika Bajaj |
| Designation |
Senior Manager, Clinical Operations |
| Affiliation |
Biogen Idec |
| Address |
Biogen Idec Biotech India Pvt Ltd
Vatika Towers B Block 14th Floor
Gurgaon
Gurgaon
HARYANA
122002
India |
| Phone |
124-4572311 |
| Fax |
124-4572333 |
| Email |
ritika.bajaj@biogenidec.com |
|
|
Source of Monetary or Material Support
|
| Biogen Idec Ltd, United Kingdom |
|
|
Primary Sponsor
|
| Name |
Biogen Idec United Kingdom |
| Address |
Biogen Idec ltd Innovation House 70 Norden Road Maidenhead Berkshire SL4 6AY United Kingdom |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Biogen Idec Biotech India Pvt Ltd |
Biogen Idec Biotech India Pvt Ltd Vatika Towers B Block 14th Floor Sector 54 Golf Course Sector Road Gurgaon 122002 |
|
|
Countries of Recruitment
|
Australia
Belgium
Brazil
Canada
China
France
Germany
Hong Kong
India
Italy
Japan
New Zealand
Poland
South Africa
Sweden
United Kingdom
United States of America |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrAlok Srivastava |
Christian Medical College, Vellore |
Department of Haematology, ,CMC Hospital,-632004
Vellore
TAMIL NADU
Vellore
TAMIL NADU |
0416-2282892
0416-2226449
haemres@cmcvellore.ac.in |
| Dr Shashikant Apte |
Sahyadari Hospital |
Department of Haematology,30,C Erandawane, Karve Road-411004
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
020-6721300
020-25459117
shashikant.apte@gmail.com |
| Dr Cecil Ross |
St.Johns Hospital Bangalore |
Department of Haematology, St Johns Hospital, Kormanagala, Bangalore-560034
Bangalore
KARNATAKA |
080-25531984
080-25531786
cecilross@sify.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, CMC Vellore |
Approved |
| Institutional Ethics Committee, Sahyadari Hospital |
Approved |
| Institutional Ethics Committee, St.Johns Hospital, Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Haemophilia B, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
rFIXFc, recombinant human coagulation FIX fusion protein |
On demand, Subjects will follow either a prophylaxis or on-demand regimen, to be determined by the Investigator. The starting dose in this study will be determined by the clinical profile of the patient in the preceding studies |
| Intervention |
rFIXFc, recombinant human coagulation FIX fusion protein |
Prophylaxis,Subjects will follow either a prophylaxis or on-demand regimen, to be determined by the Investigator. The starting dose in this study will be determined by the clinical profile of the patient in the preceding studies.
The Investigator may consider the following options for prophylaxis to target a FIX trough of up to 5% above baseline, but is encouraged to use the lowest effective dose. ï‚· Option 1: Weekly Prophylaxis
Dosing is approximately 20 IU/kg to 100 IU/kg every 7 days. The dose should be based on the subject‟s clinical profile observed in the preceding rFIXFc study and his individual pharmacokinetic profile (PK), trough, and/or peak (recovery) values. Option 2: Individualized Dosing Interval
Dosing is approximately 100 IU/kg every 8 to 16 days, or 2 times per month. The dosing interval should be based on the subject‟s clinical profile observed in the preceding rFIXFc study, and his individual PK, trough, and/or peak (recovery) values. Personalized Prophylaxis
If optimal prophylaxis dosing cannot be achieved using either of the above options, the Investigator may further personalize dosing to meet the needs of individual subjects. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations. Parental or guardian consent is required for subjects who are less than 18 years of age or unable to give consent, or as applicable per local laws. Subjects who are less than 18 years of age may provide assent in addition to the parental/guardian consent, if appropriate.
2. Subjects who have completed the studies 998HB102, 9HB02PED, or other Phase 3 studies with rFIXFc. |
|
| ExclusionCriteria |
| Details |
Confirmed positive high-titer inhibitor test (≥5.00 BU/mL)
2. Medical or other reasons that, in the opinion of the Investigator make the subject unsuitable for enrollment. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary objective of the study is to evaluate the long-term safety of rFIXFc in subjects with hemophilia B. |
4 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| number of bleeding episodes per subject |
Time Frame up to four years
|
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="7"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
28/06/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
08/12/2011 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an open-label, multicenter, long-term study of intravenous (IV) administration of rFIXFc in previously treated patients with hemophilia B, who completed the B-LONG study (998HB102), the pediatric study (9HB02PED), or any other Phase 3 trial with rFIXFc. Treatment will be administered as prophylactic or on-demand regimens. |