CTRI/2025/08/093042 [Registered on: 13/08/2025] Trial Registered Prospectively
Last Modified On:
27/07/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Non-randomized, Active Controlled Trial
Public Title of Study
This is a study of Fibrogen-I for On-demand
Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery
Scientific Title of Study
A Single Group, Non-Randomized, Multicenter, Interventional
Phase-3 Study to Investigate Efficacy, Safety and Pharmacokinetics of Fibrogen-
ITM (Human Fibrinogen Injection) for On-demand Treatment of Acute Bleeding
and to Prevent Bleeding During and After Surgery in Patients with Congenital
Fibrinogen Deficiency
Amrita Institute of Medical Sciences and Research Centre
Department of Clinical research, Room No. NA, Ponekkara, P.O- Kochi- 682041, Kerala
Ernakulam KERALA
9946047464
neerajsidharthan@aims.amrita.edu
Dr Varun Ashok Bafna
Dr Bafnas Star Super speciality Clinic and Hospital
Department of Clinical research, Room No. NA, Rikmini Nagar, E Ward, Near LIC Ground, Kolhapur- 416005, Maharashtra, India
Kolhapur MAHARASHTRA
9066565353
drvarunbafna6@gmail.com
Dr Vijay Ramanan
Grant Medical Foundation Ruby Hall Clinic
Department of Clinical research, Room No. NA, 40, Sassoon Road, Pune, Maharashtra- 411001
Pune MAHARASHTRA
9325315471
mvijayr@gmail.com
Dr Ankit Raiyani
HCG Cancer Centre
Department of Clinical research, Room No. NA, 1,Maharrashhtra Society,Mithakali Ahmedabad
Ahmadabad GUJARAT
7798438250
adraiyani@gmail.com
Dr Ramesh Uppada
HCG Cancer Centre
Department of Clinical research, Room No. NA, Plot no. 10, Survey no. 13P, APIIC Health City, Chinnagadilim Arilova, Visakhapatnam- 530040, Andra Pradesh, India.
Visakhapatnam ANDHRA PRADESH
9494708778
drramesh.u@hcgel.com
Dr Toshniwal Manoj Murlidhar
Jeevan Amruta Haematology Centre India Pvt. Ltd.
Department of Clinical research, Room No. NA, Plot no. 47, Parijat Nagar, Near Gokul Sweet, N-4 CIDCO, Aurangabad- 431007, Maharashtra
Aurangabad MAHARASHTRA
9225300842
dr.manojtwal@gmail.com
Dr Tuphan Kanti Dolai
Nil Ratan Sircar Medical College and Hospital
Department of Clinical research, Room No. NA, 138 A.J.C Bose Road, Kolkata- 700014, West Bengal, India
Kolkata WEST BENGAL
9874890275
tkdolai75@gmail.com
Dr Nita Radhakrishna
Post Graduate Institute of Child Health (PGICH)
Department of Clinical research, Room No. NA, Sector 30, Noida, Gautam Budh Nagar, Uttar Pradesh- 201303
Gautam Buddha Nagar UTTAR PRADESH
9999041524
nitark@gmail.com
Dr Cecil Ross
St. Johns Medical College
Department of Clinical
research, Room No.
NA, Sarjapur Rd, John Nagar, Koramangala, Bengaluru, Karnataka- 560034, India
Bangalore KARNATAKA
Ethics Committee, N.R.S Medical College, NRS Medical College and Hospital, Dr. Tuphan Kanti Dolai
Approved
HCG Multispecialty Ethics committee, Dr Ankit Raiyani
Approved
Institutional Ethics Committee HCG Cancer Centre, Dr. Ramesh Uppada
Approved
Institutional Ethics Committee, Dr. Neeraj Sidharthan
Approved
Institutional Ethics Committee, Dr. Nita Radhakrishna
Approved
Institutional Ethics Committee, St. Johns Medical College and Hospital, Dr. Cecil Ross
Approved
Oriion Citi care Hospital Institutional Ethics Committee (OCH IEC), Dr. Toshniwal Manoj Murlidhar
Approved
Poona Medical Research Foundation, Dr. Vijay Ramanan
Approved
Zenith Institute Ethics Committee, Dr. Varun Ashok Bafna
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: D50-D89||Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Fibrogen-I TM (Human Fibrinogen 0.5 gm/ 1 gm freeze-dried powder, manufactured
from human plasma)
Dose: Sterile freeze-dried powder form in a single-dose vial. Approximately 0.5 gm of fibrinogen per vial and Approximately 1 gm of fibrinogen per vial
Frequency: As per protocol
Route of administration: Intravenous infusion
Total duration: Varies as per Section 4.1.
Comparator Agent
NA
NA
Inclusion Criteria
Age From
0.00 Year(s)
Age To
75.00 Year(s)
Gender
Both
Details
1) Must sign an ICF (or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for the study as described in Appendix 10.1.3 and in this protocol and is willing to participate in the study. Parent(s) (preferably both if available or per local requirements) must sign an ICF indicating that they understand the purpose of, and procedures required for the study and is willing to allow the child
to participate in the study. Assent is also required of children capable of understanding the nature of the study as described in Informed Consent Process in Appendix 10.1.3.
2) Male or female.
3) Age of 0 to 75 (completed years) at the time of signing the informed consent.
4) Documented diagnosis of congenital fibrinogen deficiency manifested as afibrinogenaemia or severe hypofibrinogenaemia: Participants with a fibrinogen level undetectable, or equal or less than 50 mg per dL determined by both Clauss and antigen methods at Screening Visit.
5) Expected to require treatment for acute bleeding episode (spontaneous or after trauma [defined as any accidental event leading to acute bleeding]) or prophylaxis of bleeding before a surgical intervention or invasive procedure.
ExclusionCriteria
Details
1) Known allergies or hypersensitivity to the investigational interventions, human plasma
proteins, blood-derived products or components excipients thereof [human albumin, Larginine
hydrochloride, sodium citrate, sodium chloride; refer to the prescribing information
of Fibrogen-I that, either manifested as severe immediate hypersensitivity reactions,
including anaphylaxis prohibiting the further treatment with fibrinogen concentrate or
contraindicates participation in the study in the opinion of the investigator.
2) Documented history of immunoglobulin A (IgA) deficiency and antibodies against IgA.
3) Participants with dysfibrinogenaemia or acquired (secondary) fibrinogen deficiency.
4) Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months before the
first dose of investigational intervention. For participants with evidence of chronic hepatitis B virus (HBV) infection who are HBsAg positive but are already established on highly effective
viral suppression with HBV DNA below the Level of Quantification at screening, and when
the intent is for viral suppression to continue throughout study participation are eligible to
participate.
5) Positive hepatitis C antibody test result at screening or within 3 months before starting the
investigational intervention. NOTE: Participants with positive hepatitis C antibody due to prior
resolved disease can be enrolled only if a confirmatory negative hepatitis C Ribonucleic acid
(RNA) test is obtained. Participants with HCV infection who are currently on treatment, are
eligible if they have an undetectable HCV viral load.
6) Has known human immunodeficiency virus (HIV) seropositive status, or positive HIV
antibody test at screening. For participants with unknown HIV status, HIV testing will be
performed at screening unless prohibited by local regulations. HIV-infected participants on effective anti-retroviral therapy with an undetectable viral load within 6 months are eligible for this study.
7) Treatment with:
a) Any fibrinogen concentrate or other fibrinogen-containing blood product within 2 weeks before the start of treatment for the pharmacokinetic period.
b) Any coagulation-active drug (ie, non-steroidal anti-inflammatory drugs at doses know to have
anticoagulant effects, warfarin, coumarin derivatives, platelet aggregation inhibitors) within 1 week before the start of the treatment for the bleeding episode or surgery, or as a planned or expected medication during the period from Day 1 until 24 hours (ie, 1 day) after the last Fibrogen-I infusion.
c) Participants receiving immune-modulating drugs (other than anti-retroviral chemotherapy)
such as alpha-interferon, prednisone (equivalent to greater than 10 mg per day), or similar drugs at the start of treatment for the pharmacokinetic period.
8) Documented medical history or current evidence of before the start of treatment for the
pharmacokinetic period: Deep vein thrombosis or pulmonary embolism within 1 year. Arterial thrombosis within 1 year. Current evidence of oesophageal varicose bleeding. Current evidence of end-stage liver disease (ie, Child-Pugh score B or C).
9) Polytrauma 1 year before the start of treatment for the bleeding episode or surgery.
10) Diagnosis or suspicion of a neutralizing anti-fibrinogen inhibitor currently or at any time
before the start of treatment for the pharmacokinetic period. Suspicion of an anti-fibrinogen inhibitor may be indicated by previous in vivo recovery, if available, of less than 0.5 (mg per dL) per (mg per kg), only if available.
11) Received an investigational intervention or used an invasive investigational medical device
within 30 days or 5 half-lives before the first dose of study intervention, whichever is longer.
12) History of drug or alcohol abuse according to medical history assessment by the investigator
within 1 year before the start of treatment for the pharmacokinetic period.
13) Documented medical history of uncontrolled, clinically significant intercurrent medical
condition(s) for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or
confound the protocol-specified assessments.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
On-site computer system
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To demonstrate the haemostatic efficacy of
Fibrogen-I for the first documented bleeding
episode in participants with congenital
fibrinogen deficiency requiring on-demand
treatment of acute bleeding (spontaneous or
after trauma)
To determine the single-dose pharmacokinetics of Fibrogen-I in
participants with congenital fibrinogen
deficiency.
Day 1, Immediately prior to the scheduled infusion
Day 1, 1 hour post-infusion
Day 1, 3 hour post-infusion
Day 2, 24 hour post-infusion
Day 4, 72 hours post-infusion
Day 7, 144 hours post-infusion
Day 10, 216 hours post-infusion
Day 14, 312 hours post-infusion
Secondary Outcome
Outcome
TimePoints
To characterize further the efficacy of
Fibrogen-I in participants with congenital
fibrinogen deficiency requiring on-demand
treatment of acute bleeding (spontaneous or
after trauma).
To demonstrate the efficacy of Fibrogen-I in
preventing bleeding during and after surgery
in participants with congenital fibrinogen
deficiency.
To determine clot strength or clot
firmness [referred to as maximum clot
firmness (MCF) in this protocol] as a
surrogate pharmacodynamic marker for
haemostatic efficacy before and after
administration of Fibrogen-I in participants
with congenital fibrinogen deficiency
To demonstrate the impact of Fibrogen-I on
standard coagulation parameters in
participants with congenital fibrinogen
deficiency.
To assess the immunogenicity and safety of Fibrogen-I
in participants with congenital fibrinogen
deficiency.
Day 1, Immediately prior to the scheduled infusion
Day 1, 1 hour post-infusion
Day 1, 3 hour post-infusion
Day 2, 24 hour post-infusion
Day 4, 72 hours post-infusion
Day 7, 144 hours post-infusion
Day 10, 216 hours post-infusion
Day 14, 312 hours post-infusion
Target Sample Size
Total Sample Size="20" Sample Size from India="20" 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)
24/08/2025
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="0" Months="1" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Pharmacokinetic, Efficacy and Safety Study of Fibrogen-I for On-demand Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery