| CTRI Number |
CTRI/2021/03/032040 [Registered on: 16/03/2021] Trial Registered Prospectively |
| Last Modified On: |
09/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of FIB Grifols (i.e. human plasma-derived fibrinogen concentrate) in subjects with congenital fibrinogen deficiency (a rare bleeding disorder) |
|
Scientific Title of Study
|
A prospective, multicenter, open-label, single-arm study to evaluate the efficacy and safety of human plasma-derived fibrinogen concentrate (FIB Grifols) in subjects with congenital afibrinogenaemia and severe hypofibrinogenemia requiring either on demand treatment for acute bleeding or surgical prophylaxis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2018-004005-81 |
EudraCT |
| NCT04636268 |
ClinicalTrials.gov |
| Protocol# GC1801; Version 2.0 dated 30-March-2020 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
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| Affiliation |
|
| Address |
|
| Phone |
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| Fax |
|
| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Annappa Kamath |
| Designation |
Senior Solutions Consultant Director |
| Affiliation |
PAREXEL International Clinical Research Private Limited |
| Address |
CRS Solution consultant department
CoWrks, Coworking Spaces Pvt. Ltd. – RMZ Eco World, Ground Floor, Bay Area – Adjacent to Building 6A, Outer Ring Road, Devarabeesanahalli Village, BENGALURU – 560103, Karnataka, INDIA
Bangalore
KARNATAKA
560103
India |
| Phone |
918067169360 |
| Fax |
918067723001 |
| Email |
Annappa.Kamath@PAREXEL.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Annappa Kamath |
| Designation |
Senior Solutions Consultant Director |
| Affiliation |
PAREXEL International Clinical Research Private Limited |
| Address |
CRS Solution Consultant department
CoWrks, Coworking Spaces Pvt. Ltd. – RMZ Eco World, Ground Floor, Bay Area – Adjacent to Building 6A, Outer Ring Road, Devarabeesanahalli Village, BENGALURU – 560103, Karnataka, INDIA
Bangalore
KARNATAKA
560103
India |
| Phone |
918067169360 |
| Fax |
918067723001 |
| Email |
Annappa.Kamath@PAREXEL.com |
|
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Source of Monetary or Material Support
|
| Instituto Grifols, S.A., Can Guasch, 2, 08150 Parets del Vallès, Barcelona, Spain |
|
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Primary Sponsor
|
| Name |
Instituto Grifols SA |
| Address |
Can Guasch, 2, 08150 Parets del Vallès, Barcelona, Spain |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
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Details of Secondary Sponsor
|
| Name |
Address |
| PAREXEL International Clinical Research Private Limited |
CoWrks, Coworking Spaces Pvt. Ltd. – RMZ Eco World, Ground Floor, Bay Area – Adjacent to Building 6A, Outer Ring Road, Devarabeesanahalli Village, BENGALURU – 560103, Karnataka, INDIA |
|
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Countries of Recruitment
|
Bulgaria
India
Lebanon
Turkey
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 Tuphan Kanti Dolai |
Nil Ratan Sircar Medical College & Hospital |
Department of Hematology, 4th floor, HOD chamber, 138, Acharya J. C. Bose Road, West Bengal India
Kolkata
WEST BENGAL |
9874890275
tkdolai@hotmail.com |
| Dr Nirmalkumar Ganeshmal Choraria |
Nirmal Hospital Pvt Ltd |
Department of Pediatrics, OPD No.1, First floor, Ring Road, Gujarat
Surat
GUJARAT |
912612333999
drnirmalchoraria@gmail.com |
| Dr Kannan Subramanian |
Sahyadri Super Speciality Hospital |
Department of Hematology & bone marrow transplant, First floor, 30 – C Erandawane, Karve Road, Pune
Maharashtra, India
Pune
MAHARASHTRA |
02067213000
dockannan@gmail.com |
| Dr Ross Cecil Reuben |
St. Johns Medical College Hospital |
Room No.52, Division of
Clinical Trials, Dept. of Medicine and Hematology, Sarjapur Road – 560034,Bangalore, Karnataka, India
Bangalore
KARNATAKA |
8022065229
cecilrross@gmail.com |
| Dr Meera V |
Victoria Hospital |
Department of Clinical Hematology, Ground Floor, Block H, K.R.Road, Fort, Karnataka
Bangalore
KARNATAKA |
918026706264
drmeeravaradarajan@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Ethics Committee of Bangalore Medical College and Research Institute |
Approved |
| Institutional Ethics Committee |
Approved |
| Nirmal Hospital Pvt. ltd. Ethics Committee |
Approved |
| NRS Ethics Committee |
Approved |
| Sahyadri Hospitals Limited Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D682||Hereditary deficiency of other clotting factors, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FIB Grifols |
Dosing will be individually calculated for each subject based on the target plasma fibrinogen level according to the type of bleeding, measured actual plasma fibrinogen level before infusion, and body weight. The IP will be administered according to the nominal potency of the product. |
| Comparator Agent |
Not applicable |
Not applicable (single-arm study) |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Male or female subject between 6 to 70 years of age
2 Signed and dated written ICF, or the subjects parent or legal guardian signs and dates the ICF where applicable, and the Subject Authorization Form SAF where applicable, Pediatric subjects, as defined by local regulations, will be asked to sign an age appropriate assent form
3 Diagnosed with congenital fibrinogen deficiency manifested as afibrinogenemia or severe hypofibrinogenemia (fibrinogen <50 mg/dL) and expected to require treatment for acute bleeding (either spontaneous or after trauma [defined as any accidental event leading to acute bleeding], or prophylaxis of bleeding before a surgical intervention or invasive procedure
4 Fibrinogen level < 50 mg/dL determined by Clauss method at baseline (sample drawn within 24 hours prior to infusion on Infusion 1 Day 1 Visit)
5 Female subjects of child-bearing potential must have a negative test for pregnancy blood or urine human chorionic gonadotropin (HCG)-based assay at baseline (sample drawn within 24 hours prior to infusion on Infusion 1 Day 1 Visit)
6 Willing to comply with all aspects of the clinical trial protocol, including blood sampling, for the entire duration of the study |
|
| ExclusionCriteria |
| Details |
1 Has acquired (secondary) fibrinogen deficiency
2 Diagnosed with dysfibrinogenemia
3 Has known antibodies against fibrinogen
4 Has history of anaphylaxis or severe systemic response to any drug or blood-derived product
5 Has history of intolerance to any component of the IP
6 Documented history of immunoglobulin A (IgA) deficiency and antibodies against IgA
7 Is a female who is pregnant, breastfeeding or, if of child-bearing potential, unwilling to practice a highly effective method of contraception (eg, oral, injectable, or implantable hormonal methods of contraception, placement of an IUD or intrauterine system, condom or occlusive cap with spermicidal foam/gel/film/cream/suppository, male sterilization, or true abstinancea) throughout the study
8 Has any medical condition which is likely to interfere with the evaluation of the IP and/or the satisfactory conduct of the clinical trial according to the investigators judgment
9 Has congenital or acquired bleeding disorders other than congenital fibrinogen deficiency
10 Has life expectancy of less than 6 months
11 Received FRT within 21 days prior to the Screening Visit
12 Receiving, or having received within 3 months prior to the Screening Visit of this clinical trial, any investigational drug or device
13 Is unlikely to adhere the protocol requirements, or is likely to be uncooperative, or unable to provide a storage sample prior to IP infusion |
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
1.Hemostatic efficacy of FIB Grifols in on-demand treatment of all documented acute bleeding episodes as assessed by the Independent Endpoint Adjudication Committee (IEAC) Using a 4-Point Scale
2.Hemostatic efficacy of FIB Grifols in perioperative management of bleeding during and after all documented surgical procedures as assessed by the IEAC Using a 4-Point Scale |
1.Up to Day 7
2.Up to Day 7 |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Hemostatic Efficacy of FIB Grifols in Treating the First Documented Acute Bleeding Episode as Assessed by the IEAC Using a 4-Point Scale |
Up to Day 7 |
| Hemostatic Efficacy of FIB Grifols in Preventing Excessive Bleeding During and After the First Documented Surgical Procedure as Assessed by the IEAC Using a 4-Point Scale |
Up to Day 7 |
| Hemostatic Efficacy of FIB Grifols in Treating the First Acute Bleeding Episode |
Up to Day 7 |
| Hemostatic Efficacy of FIB Grifols in Treating All Acute Bleeding Episodes |
Up to Day 7 |
| Hemostatic Efficacy of FIB Grifols in Preventing Excessive Bleeding Intra-operatively for All Surgical Procedures |
Up to Day 7 |
| Hemostatic Efficacy of FIB Grifols in Preventing Excessive Bleeding After All Surgical Procedures (ie, Post-operative) |
Up to Day 7 |
|
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Target Sample Size
|
Total Sample Size="32"
Sample Size from India="16"
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)
|
23/03/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
23/03/2021 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
This is a phase 3, multi-center, prospective,
open-label, single-arm, clinical trial to be carried out in subjects with
congenital fibrinogen deficiency manifested as afibrinogenemia or severe
hypofibrinogenemia.
This clinical trial is planned to be performed
at study sites in multiple countries. It is planned to include a maximum of 32
adult and pediatric subjects with congenital fibrinogen deficiency in order to
provide at least 28 evaluable acute bleeding episodes and/or surgical procedures |