| CTRI Number |
CTRI/2012/07/002772 [Registered on: 06/07/2012] Trial Registered Retrospectively |
| Last Modified On: |
24/08/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Long-Term Safety and Efficacy of Recombinant Human Coagulation Factor VIII Fusion Protein (rFVIIIFc) |
|
Scientific Title of Study
|
An Open-Label, Multicenter Evaluation of the Long-Term Safety and Efficacy of Recombinant Human Coagulation Factor VIII Fusion Protein (rFVIIIFc) in the Prevention and Treatment of Bleeding Episodes in Previously Treated Subjects With Hemophilia A |
| Trial Acronym |
ASPIRE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 8HA01EXT |
Protocol Number |
|
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 |
CRCL |
| Affiliation |
Biogen Idec Biotech India Pvt Ltd |
| Address |
Biogen Idec Biotech India Pvt Ltd Vatika Towers, B Block, 14th Floor Sector 54, Golf Course Sector Road
Gurgaon
Gurgaon
HARYANA
122002
India
Biogen Idec Biotech India Pvt Ltd Vatika Towers, B Block, 14th Floor Sector 54, Golf Course Sector Road
Gurgaon
Gurgaon
HARYANA
122002
India
Gurgaon
HARYANA
122002
India |
| Phone |
124-4572311 |
| Fax |
124-4572333 |
| Email |
ritika.bajaj@biogenidec.com |
|
|
Source of Monetary or Material Support
|
| Biogen Idec Ltd Innovation House Norden Road Maidenhead Berkshire United Kingdom SL AY Innovation House 70 Norden Road Maidenhead, Berkshire United Kingdom SL6 4AY |
|
|
Primary Sponsor
|
| Name |
Biogen Idec Ltd |
| Address |
Innovation House 70 Norden Road Maidenhead, Berkshire United Kingdom SL6 4AY |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Australia
Austria
Belgium
Chile
China
Germany
Hong Kong
India
New Zealand
Sweden
United Kingdom
United States of America |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Joseph John |
Christian Medical College , Ludhiana |
Department of Hematology and Bone Marrow Transplant, Christian Medical College & Hospital, Brown Road, Ludhiana, INDIA.
Ludhiana
PUNJAB
Ludhiana
PUNJAB |
919878659525
9101612229011
mjosephjohn@gmail.com |
| Dr Alok Srivastava |
Christian Medical College, Vellore |
Department of Haematology, Christian Medical College, Vellore - 632004, India
Vellore
TAMIL NADU
Vellore
TAMIL NADU |
91416-2282352
914162226449
aloks@cmcvelore.ac.in |
| Dr Naresh Gupta |
Maulana Azad Medical College & Lok Nayak Hospital |
Haemophilia Day care Centre, Maulana Azad Medical College & Lok Nayak Hospital, New Delhi, India.
Central
DELHI
New Delhi
DELHI |
919968604271
911123221922
doctornaresh@nic.in |
| Dr Shashikant Apte |
Sahaydari Hospital |
Department of Hematology, Sahyadri Speciality Hospital, Karve Road, Plot no.30 – C, Erandwane, Deccan Gymkhana, Pune- 411004
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
919822404983
912025459917
shashikant.apte@gmail.com |
| Dr Cecil Ross |
St. Johns Medical College Hospital |
St. Johns Medical College Hospital, Department of Medicine (Haematology), Sarjapur Road Bangalore, 560034
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
80-22065722
08025531984
cecilross@sify.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Institiute Ethics Commitee, CMC Ludhiana |
Approved |
| Institutional Ethical Review Board |
Approved |
| Institutional Ethics Commitee |
Approved |
| Institutional Ethics Commitee, CMC, Vellore |
Approved |
| Institutional Ethics Commitee, MAMC, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Severe Haemophilia A , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
on demand |
rFVIIIFc
IV administration
Subject 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 |
Option 1: Tailored Prophylaxis |
rFVIIIFc
IV administration
Subject 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 Dosing is approximately 25 IU/kg to 65 IU/kg every 3 to 5 days, or dosing 2 times per week at approximately 20 IU/kg to 65 IU/kg on Day 1 and 40 IU/kg to 65 IU/kg on Day 4. |
| Intervention |
Option 2 /Weekly Dosing (Modified Prophylaxis) Regimen |
Dosing is approximately 65 IU/kg at weekly intervals. The dose should be based on the subject’s clinical profile observed in the preceding rFVIIIFc study and/or his individual PK (if available), and FVIII trough and/or peak (recovery) values. |
|
|
Inclusion Criteria
|
| Age From |
18.00 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.
2. Subjects who have completed Study 997HA301.
|
|
| ExclusionCriteria |
| Details |
1. 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
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Number of hospitalizations, excluding planned hospitalizations, elective surgery documented at Visit 1, and emergent surgery
• Number of emergency room visits
• Number of physician visits, excluding study visits
• Number of hospitalization days
• Number of days off work or school
• Number of days off work for a parent/caregiver (demographic data for parents/caregivers will be collected at Visit 1)
|
• Number of hospitalizations, excluding planned hospitalizations, elective surgery documented at Visit 1, and emergent surgery
• Number of emergency room visits
• Number of physician visits, excluding study visits
• Number of hospitalization days
• Number of days off work or school
• Number of days off work for a parent/caregiver (demographic data for parents/caregivers will be collected at Visit 1)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary objective of the study is to evaluate the efficacy of rFVIIIFc in the prevention and treatment of bleeding episodes in subjects with hemophilia A. |
The number of annualized bleeding episodes (spontaneous and traumatic) per subject
The number of annualized spontaneous joint bleeding episodes per subject
The total number of days of exposure per subject per year
The mean dose of rFVIIIFc per kg per subject per year per treatment regimen
Physician’s global assessment of response to treatment using a 4-point scale
Subject’s assessment of response to treatment using a 4-point scale
The incidence of AEs and serious adverse events (SAEs)
|
|
|
Target Sample Size
|
Total Sample Size="194"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/07/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
06/12/2011 |
| 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
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
8HA01EXT is an extension study designed to assess the long-term safety and efficacy of recombinant factor VIII fusion (rFVIIIFc) in previously treated subjects with hemophilia A. Male subjects of all ages who have completed the preceding study of rFVIIIFc (997HA301 [A‑LONG]) may be eligible for enrollment in this study. |