| CTRI Number |
CTRI/2012/04/002596 [Registered on: 24/04/2012] Trial Registered Prospectively |
| Last Modified On: |
01/08/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical trial to see the effect of EMOCLOT drug (Kedrion factor VIII concentrate) in 50 previously treated Heamophilia A Children. |
|
Scientific Title of Study
|
Open Label, Phase III, Multicenter study on Pharmacokinetic, Efficacy and Safety evaluation of Kedrion Factor VIII concentrate (EMOCLOT) in 50 previously treated Haemophilia A Children. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| KB053 Version 01 dated 19 September 2011 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Cecil Ross |
| Designation |
Professor & Head, Department of Medicine |
| Affiliation |
St. Johns Medical College & Hospital |
| Address |
St. Johns Medical College & Hospital,Sarjapur Road, Bangaluru.
Bangalore
KARNATAKA
560034
India |
| Phone |
91-9448493705 |
| Fax |
91-80-25501144 |
| Email |
cecilross@bsnl.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Atul Gupta |
| Designation |
Medical Monitor |
| Affiliation |
Max Neeman International |
| Address |
Max Neeman International, Max House,1st Floor, #1, Dr. Jha Marg, Okhla Phase-III.
New Delhi
DELHI
110020
India |
| Phone |
91-9717287654 |
| Fax |
91-11-41001945 |
| Email |
atulg@neemanasia.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shariq Anwar |
| Designation |
Director Operations |
| Affiliation |
Max Neeman International |
| Address |
Max Neeman International, Max House,1st Floor, #1, Dr. Jha Marg, Okhla Phase-III.
New Delhi
DELHI
110020
India |
| Phone |
91-09810979215 |
| Fax |
91-1141001945 |
| Email |
sanwar@neemanasia.com |
|
|
Source of Monetary or Material Support
|
| Kedrion SpA
Loc. Ai Conti
55051 Castelvecchio Pascoli (Lucca),
Italy. |
|
|
Primary Sponsor
|
| Name |
Sintesi Research Srl |
| Address |
Via G. Ripamonti,89
20141 Milano-Italy. |
| Type of Sponsor |
Contract research organization |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Max Neeman International |
Max Neeman International
Max House, 1 Dr. Jha Marg,
Okhla Phase-III, New Delhi - 110020. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr R Varadarajan |
Centre for Blood Disorders |
Department of Hematology
Room Number 3
73, Habibullah Road, T. Nagar
Chennai
TAMIL NADU |
91-9840119052
91-44-28340668
rvraj12345@gmail.com |
| Dr Vijay Ramanan Madatha |
Jehangir Clinical Development Centre Pvt. Ltd. |
Department of Hematology, Ground Floor, Jehangir Hospital Premises, 32, Sassoon Road.
Pune
MAHARASHTRA |
91-9325315471
91-20-26059319
mvijayr@gmail.com |
| Dr Dinesh M Nayak |
Kasturba Hospital |
Department of Paediatrics
First Floor, Madhav Nagar, Manipal.
Udupi
KARNATAKA |
91-9845226437
91-820-2922083
dinesh_nayak@yahoo.com |
| Dr Shashikant Apte |
Sahyadri Speciality Hospital |
Room Number 8, Department of Hematology & Bone Marrow Transplant, 30C , Erandawane, Karve Road.
Pune
MAHARASHTRA |
91-9822404983
91-20-25459117
shashikant.apte@gmail.com |
| Dr Cecil Ross |
St. Johns Medical College & Hospital |
Department of Medicine, 5th Floor,Sarjapur Road.
Bangalore
KARNATAKA |
91-9448493705
91-80-25501144
cecilross@bsnl.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| CLINICOM |
Approved |
| Jenhangir Clinical Development Centre Institutional Review Board |
Approved |
| Manipal University Ethics Committee |
Submittted/Under Review |
| Sahyadri Hospitals Limited Ethics Committee |
Submittted/Under Review |
| St. Johns Medical college & Hospital(Institutional Ethical Review Board) |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Severe Haemophilia A Children, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
EMOCLOT |
EMOCLOT 500 IU/10 mL Powder and solvent for solution for infusion.
EMOCLOT 1000 IU/10 mL Powder and solvent for solution for infusion
Posology: a standard dose of 25-50 IU/kg FVIII will be administered to patients. The dose of concentrate to be infused will be calculated on the basis of the exact patient’s body weight obtained the same day of infusion and rounded up or down to the strength employed.
For long term prophylaxis against bleeding in patients with severe haemophilia A, the usual doses are 20 to 40 IU of factor VIII per kg body weight at intervals of 2 to 3 days.
Route of administration will be intravenous.
Duration of therapy is 3 years or 50 Exposure days whichever comes first. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Previously treated patients aged <12 years.
2.Prior to study entry, subjects should have a history of at least 50 exposure days for all types of factor VIII containing products, including fresh frozen plasma (FFP). This minimum exposure rate shall be estimated by the Heamophilia treating physician.
3.Subjects should have severe or moderately severe Heamophilia A as defined by a baseline factor VIII level <1%, documented at pre-enrolment screening on the basis of anamnesis data (i.e., at heamophilia diagnosis).
4.If subjects are HIV-1 seropositive they should have a CD4+ lymphocyte count ≥ 200/µl documented on 2 consecutive occasions over a 12 months period prior to study entry. The latest CD4+ lymphocyte count qualifying the patient for enrolment (i.e. ≥ 200/µl) should be within 6 months before enrolment in the study.
5.Legally authorized representatives of the subjects should be informed of the nature of the study, agree to its provision, and sign and date an informed consent and authorization for the participation and data handling approved by the IRB/IEC.
6.Subjects who will be available for the duration of the study will be included. |
|
| ExclusionCriteria |
| Details |
1.Subjects with a detectable inhibitor to factor VIII at the time of enrolment or a history of inhibitor to factor VIII ( 0.6 BU).
2.Subjects HIV positive who are treated with highly active anti-retroviral therapy (HAART) regimen.
3.Subjects with any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives, or participation in this trial.
4.Informed Consent and/or the Authorization for Data Handling approved by the EC not signed by parents/legal guardians.
5.Subjects who have participated in another clinical trial within 1 month before study initiation, i.e. they have received any test drug within 30 days prior the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.)Efficacy: Evaluation of the haemostatic efficacy of Kedrion human plasma-derived factor VIII EMOCLOT in the management of acute bleeding events.
2.)Safety: Assessment of the risk of inhibitor (neutralizing anti-factor VIII antibodies) development in conjunction with infusion of the IMP throughout the study period. |
At 10-15 EDs or Every 3 Months
At 25±2 EDs and at 50 EDs
For PK study participating subject safety and efficacy assessment also will be done at pre infusion and 30 Minutes, 1-3 hours, 4-6 hours, 10-14 hours, 20-26 hours & 32-48 hours post infusion.
|
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
None as Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Note: There was no recruitment in the study and it was never initiated. The study has also been withdrawn; notification regarding the same has also been submitted to DCGI.
Protocol Title: Open Label, Phase III, Multicenter study on Pharmacokinetic, Efficacy and Safety evaluation of Kedrion Factor VIII concentrate (EMOCLOT) in 50 previously treated Haemophilia A Children. Objective: - Evaluation of the Pharmacokinetics, safety & efficacy assessment of the EMOCLOT.
Efficacy: · Evaluation of the haemostatic efficacy of Kedrion human plasma-derived factor VIII EMOCLOT in the management of acute bleeding events Safety: · Assessment of the risk of inhibitor (neutralizing anti-factor VIII antibodies) development in conjunction with infusion of the IMP throughout the study period. · Evaluation of short & medium term safety of the IMP when administered to severe previously treated hemophilia A subjects. Evaluation of immediate and delayed local tolerability |