| CTRI Number |
CTRI/2018/05/013790 [Registered on: 09/05/2018] Trial Registered Prospectively |
| Last Modified On: |
09/09/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study for HemoRel-A® in Hemophilia A patients
|
|
Scientific Title of Study
|
Prospective, multi-centre, clinical study to evaluate the
efficacy, safety and pharmacokinetics of HemoRel-A® in Hemophilia A patients |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| RLS/PMS/2017/02; Version 2.0, Dated: 21 Jan 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Savita Rangarajan |
| Designation |
Clinical Hematologist and Director |
| Affiliation |
Prerana Health Care Foundation |
| Address |
Prerana Health Care Foundation
5/124 Bhaskaer Nivas, Sion East, Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9619525341 |
| Fax |
|
| Email |
rangarajansavita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Savita Rangarajan |
| Designation |
Clinical Hematologist and Director |
| Affiliation |
Prerana Health Care Foundation |
| Address |
Prerana Health Care Foundation
5/124 Bhaskaer Nivas, Sion East, Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9619525341 |
| Fax |
|
| Email |
rangarajansavita@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Savita Rangarajan |
| Designation |
Clinical Hematologist and Director |
| Affiliation |
Prerana Health Care Foundation |
| Address |
Prerana Health Care Foundation
5/124 Bhaskaer Nivas, Sion East, Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9619525341 |
| Fax |
|
| Email |
rangarajansavita@gmail.com |
|
|
Source of Monetary or Material Support
|
| Reliance Life Sciences Pvt. Ltd.
Dhirubhai Ambani Life Sciences Centre
Plot R-282, TTC Area of MIDC
Thane Belapur Road
Rabale, Navi Mumbai 400 701 |
|
|
Primary Sponsor
|
| Name |
Dr Savita Rangarajan |
| Address |
Prerana Health Care Foundation
5/124 Bhaskaer Nivas, Sion east, Mumbai 400022 |
| Type of Sponsor |
Other [Co-ordinating Investigator for Investigator initiated study] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sonali Salvi |
B. J. Medical Colloege and Sassoon General Hospital, Pune |
Room No 4 (Cabin No 4) Third floor, Hospital Building, Department of Medicine, Pune - 411001
Pune
MAHARASHTRA |
9422508154
sonalionly@gmail.com |
| Dr Subhaprakash Sanyal |
Fortis Hospitals Limited |
Mulund Goregaon Link Road,
Bhandup (W), Mumbai 400078,
Maharashtra, India
Mumbai
MAHARASHTRA |
9920230809
ssanyal74@gmail.com |
| Dr Savita Rangarajan |
K.J Somaiya Hospital and Research Centre |
College Building, Somaiya Ayurvihar Complex, Behind Everard Nagar, Eastern Express Highway, Sion East, Mumbai-400022
Mumbai
MAHARASHTRA |
9619525341
rangarajansavita@gmail.com |
| Dr R P Agrawal |
S.P.Medical College & Associated Group (AG) of Hospitals |
Department of Medicine, Bikaner - 334003, Rajasthan,
Bikaner
RAJASTHAN |
01512202131
drrpagrawal@yahoo.co.in |
| Dr Javid Rasool |
Sher-I-Kashmir Institute of Medical Sciences, Srinagar |
Room No 1212,First Floor, Soura, Bemina, Srinagar, Jammu and Kashmir - 190011
Jammu
JAMMU & KASHMIR |
9149436376
dr_javidrasool@yahoo.co.uk |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Ethics Committee S.P.Medical College & AG Hospitals Bikaner |
Approved |
| Institutional Ethics Committee Fortis Hospitals Limited, Bhandup (W) |
Approved |
| Institutional Ethics Committee, K.J Somaiya Medical College & Research Centre, Mumbai |
Approved |
| Institutional Ethics Committee, B.J.M.C. & S.G.H. |
Approved |
| Institutional Ethics Committee, SKIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Hemophilia A, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HemoRel-A |
Dose: 20-40 IU/kg; Intravenous route; on demand administration |
| Comparator Agent |
Not applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
1.Male subjects aged between 18 to 65 years (both inclusive.
2.Subjects with severe hemophilia A (documented factor VIII levels lesser than 1 percent) who are
receiving on-demand treatment.
3.History of greater than 12 bleeding events in the past 12 months.
4. Number of exposure days before inclusion greater than 50 ED.
5.Immunocompetent with CD4 lymphocytes greater than 200/μl.
6. HIV negative or having a viral load less than 200 particles/μl approx 400000 copies/ml.
7.Willing to provide written Informed Consent.
8.Able to adhere to study schedules and requirements. |
|
| ExclusionCriteria |
| Details |
1. Subjects with history of inhibitors to FVIII
2. Any other inherited or acquired bleeding disorder
3. Subjects with any major systemic illness, and/or had known hypersensitivity to
HemoRel-A® or any of its component.
4. Subjects with abnormal laboratory parameters like:
 Serum creatinine greater than 1.5 times of upper normal limit
 AST or ALT greater 3 times of upper normal limit
 Platelet count less than 100,000/μL
 Hemoglobin less than 10.0 gm/dL
 Neutrophils less than 1.5 X 10 raised to 3/μL
5. History of clinically significant diseases, e.g. epilepsy, diabetes, cardiovascular,
gastro-intestinal, hepatic, renal, pulmonary, or abdominal disease.
6. Subject participation in any other clinical trial 30 days prior to administration of IP.
7. Any other condition which investigator feels would affect interpretation of the
results or render the subject at high risk. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Response of acute bleeding events to treatment based on a 4-point scale (excellent, good, moderate or none) |
Response of acute bleeding will be assessed at 8 Hours and at 72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of safety |
0, 3, 8, 24, 72 hrs |
| Immunogenecity |
Baseline and End of study |
| Pharmacokinetic assessment |
pre-infusion (within 15 minutes prior to infusion), and 10 minutes (end of
infusion), 30 minutes, 1, 3, 6, 9, 24, 28, 32 and 48 hours post-infusion |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "44"
Final Enrollment numbers achieved (India)="44" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
21/05/2018 |
| Date of Study Completion (India) |
30/03/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is a prospective, multi-centre, clinical study to evaluate the efficacy, safety and pharmacokinetics of HemoRel-A® in Hemophilia A patients.
Patients with hemophilia-A experience frequent life-threatening spontaneous and traumatic bleeding, particularly in joints and muscle. Recurrent hemarthrosis is a major cause of morbidity in patients with hemophilia. The introduction of coagulation factor replacement therapy over the past half century has greatly contributed to the improvement in care of people with hemophilia. The improvement of viral inactivation methods and methods used to screen viruses in blood donation facilities and plasma pools also greatly improved the safety of plasma-derived products. Replacement of the specific missing plasma protein is necessary for hemostasis to occur and hence products are required for longer duration for such patients.
Many considerations including efficacy, cost, safety, and ease of administration are important in selection of any specific factor VIII for treatment.
Plasma Derived Factor-VIII (HemoRel-A®) manufactured by Reliance Life Sciences Pvt. Ltd., India, is being used in patients with severe hemophilia. Plasma Derived Factor-VIII (HemoRel-A®) is generally effective and well tolerated in patients. The aim of this study is to assess the efficacy and safety aspects of Plasma Derived Factor-VIII (HemoRel-A®) in a controlled environment.
|