FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/09/094511 [Registered on: 10/09/2025] Trial Registered Prospectively
Last Modified On: 10/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   An Open-label Study for the Treatment and Prophylaxis in Severe Hemophilia a Patients 
Scientific Title of Study   A Phase 1/3, Open-label, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of Human Plasma-derived Factor VIII (SKP-0141) for the treatment and prophylaxis in Male Patients with Severe Hemophilia A. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
SKP-0141_HemA_l/III_2024 version No. 2.0 dated 19- MAR-2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query
 
Name  Shweta Pradhan 
Designation  Head Clinical Operations 
Affiliation  IQVIA RDS (India) Private Limited 
Address  Omega Embassy Tech Square, Marathahalli - Sarjapura, Outer Ring Road, Kadubeesanahalli, Karnataka

Bangalore
KARNATAKA
560103
India 
Phone  919513774664  
Fax    
Email  shweta.pradhan@iqvia.com  
 
Details of Contact Person
Public Query
 
Name  Shweta Pradhan 
Designation  Head Clinical Operations 
Affiliation  IQVIA RDS (India) Private Limited 
Address  Omega Embassy Tech Square, Marathahalli - Sarjapura, Outer Ring Road, Kadubeesanahalli, Karnataka


KARNATAKA
560103
India 
Phone  919513774664  
Fax    
Email  shweta.pradhan@iqvia.com  
 
Source of Monetary or Material Support  
SK Plasma Co., Ltd. 310 Pangyo-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea, 13494. 
 
Primary Sponsor  
Name  SK Plasma Co Ltd 
Address  310 Pangyo-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea, 13494. 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
IQVIA RDSIndia Pvt Ltd  Omega Embassy TechSquare, Marathahalli-Sarjapur Outer Ring Road, Kadubeesanahalli, Bangalore – 560103, Karnataka 
 
Countries of Recruitment     India
Indonesia
Malaysia
Philippines
Republic of Korea
Thailand
Turkey  
Sites of Study  
No of Sites = 8  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vijay Ramanan   Grant Medical Foundation Ruby Hall Clinic  40 Sassoon Road, Pune-411001, Maharashtra India
Pune
MAHARASHTRA 
9822240022

bmtpune@gmail.com 
Dr Smita Das  Guwahati Medical College and Hospital   Narakasur Hilltop Hospital Road Bhangagarh Guwahati Assam - 781032
Kamrup
ASSAM 
9864068293

smitabhuyanghy@gmail.com 
Dr Sunita Aggarwal  Maulana Azad Medical College and Associated Hospitals  Room no 122, Department of Medicine,B L Taneja Block,Maulana Azad Medical College, New Delhi 110002, India
New Delhi
DELHI 
9686042866

drsunita.mamc@gmail.com 
Dr Dharmesh Rameshbhai Vaghasiya  Nirmal Hospital Pvt Ltd  Ring Road, Surat-395002, Gujarat, India
Surat
GUJARAT 
7767054520

drdharmeshrvaghasiya@gmail.com 
Dr KK Radhika  Nizam s Institute of Medical Sciences   Dept of Haematology. Nizam s Institute of Medical Sciences, Punjagutta, Hlyderabad, Telangana- 500082
Hyderabad
TELANGANA 
9494649657

radhika_setti@yahoo.com  
Dr Shashikant Janardan Apte   Sahyadri super Speciality Hospital.  Plot No. 30C, Erandawane, karve Road, Pune 411004 Maharashtra
Pune
MAHARASHTRA 
919175980913

shashikant.apte@gmail.com 
Dr Cecil Reuben Ross  St. John’s Medical College Hospital   St. John’s Medical College Hospital, Sarjapur main road, John nagar, Koramangala, Bangalore - 560034, Karnataka, India
Bangalore
KARNATAKA 
9448493705

cecil.ross@stjohns.in 
Dr Alok Ranjan  State Cancer Institute Indira Gandhi Institute of Medical Sciences  Sheikhpura, Patna-800014, Bihar, India
Patna
BIHAR 
9572240838

dralokranjansciigims@gmail.com  
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
Aurangabad Health Care and Research LLP IEC  Approved 
Institutional Ethics committee Poona Medical Research Foundation, Dr Vijay Ramanan  Approved 
Institutional Ethics Committee MAMC, Dr Sunita Aggarwal  Submittted/Under Review 
Institutional Ethics Committee State Cancer Institute Indira Gandhi, Dr. Alok Ranjan  Approved 
Institutional Ethics Committee, GMCH Gauhati Medical College,Dr. Smita Das  Approved 
Institutional Ethics Committee, St. John’s Medical College Hospital  Submittted/Under Review 
NIMS Institutional Ethics Committee,Dr K.K. Radhika  Approved 
Nirmal Hospital Pvt Ltd Ethics Committee, Dr. Dharmesh Vaghasiya  Approved 
Sahyadri Hospitals Pvt. Ltd. Ethics Committee, Dr. Shashikant Janardan Apte  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D66||Hereditary factor VIII deficiency,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Study Drug Name: SKP-0141  Route: IV injection Dose: Lyophilized powder and solvent for solution for injection Dose Range: 25 to 50 IU/kg Treatment period: 25 weeks  
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  65.00 Year(s)
Gender  Male 
Details  Patients are eligible to be included in the study only if all of the following criteria apply:

1. A patient or parent/legal guardian (as appropriate) who is capable of giving signed informed consent, and where required, the patient is capable of providing assent), which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF), Assent Form, and in this protocol.

2. Patients assigned male at birth and must be 12 to 65 years old (inclusive) at the time of Screening (signing the ICF by the patient or their parent/legal guardian or provision of assent, as appropriate).

3. Diagnosis of severe congenital hemophilia A, defined as an FVIII level of greater than 1 percent as documented in the patient’s medical records. Note, if available documented evidence of FVIII level is not within 4 weeks of Screening visit, a baseline FVIII level assessments will be done at Screening.

4. Patients who have received or are currently receiving plasma-derived and or recombinant FVIII products and have had at least 150 EDs with a FVIII product.

5. Patients who can produce viable sperm and have a partner of childbearing potential must agree to take appropriate contraceptive measures consistently during the study, starting at Screening and until 30 days after the end of study (EOS) visit and also refrain from donating sperm during this period. Patients with a partner or partners who is (are) not of childbearing potential are exempt from these requirements. 
 
ExclusionCriteria 
Details  Patients are excluded from the study if any of the following criteria apply:

1. Any history of or current FVIII inhibitors or any first order family history of FVIII inhibitors in terms of detectable FVIII inhibitors (ie, less than or equal to 0.6 Bethesda Units [BU]) using the Nijmegen-modification of the Bethesda assay

2. Any known congenital or acquired coagulation disorder other than the congenital hemophilia A.

3. Evidence of thrombosis, including deep vein thrombosis, stroke, pulmonary embolism, myocardial infarction, and arterial embolus within 3 months prior to Visit 1.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Annualized bleeding rate (number of bleeding episodes per year)   Visit 10  
 
Secondary Outcome  
Outcome  TimePoints 
• Patient assessment of hemostatic response for any breakthrough bleeding episode, using a 4-point scale from start of treatment and until Visit 10
• Dose of SKP-0141 injections (IU/kg/year and IU/kg/month) required for prophylaxis from start of treatment and until Visit 10
 
Visit 10 
 
Target Sample Size   Total Sample Size="55"
Sample Size from India="17" 
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)   22/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/09/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

This is a prospective, multicenter, open-label study of human plasma-derived FVIII in previously treated patients with severe hemophilia A. Overall, 55 male PTPs with a FVIII level of less than 1percent and at least 150 treatment exposure days to previous FVIII products will be enrolled.

Patients will undertake a Screening visit between Week 4 to Week 0 to determine their eligibility to be enrolled in the study. All eligible patients will enter the Treatment period of the study to receive study treatment. During the Treatment period- Weeks 1 to 25, patients will receive prophylactic treatment with SKP-0141.

At least the first 12 enrolled patients -PK group, will participate in the PK assessments at Visit 1-single-dose PK,  and Visit 10- steady-state PK. The single-dose PK assessments will be performed at first exposure to SKP-0141- 25 to 50 IU per kg after a minimum of 72-hour washout period, which may be extended up to 96 hours for long half-life FVIII products, from their last marketed FVIII administration. The steady-state PK assessments will be performed around 25 weeks following initiation of prophylactic treatment, subsequent to a minimum of 48-hour washout period from their prophylactic SKP-0141 administration. For PK assessments, patients will undergo blood sampling at predefined time points. If patients experience a bleeding episode (BE) during the initial PK assessment period, they may be treated with their previous FVIII product. Once the BE is controlled the patient may restart the PK assessment following the appropriate washout period from their last marketed FVIII administration.

After the 12 patients in the PK group complete the single-dose PK assessments- Visit 1, the available safety and PK endpoints data will be reviewed by the Independent Data Monitoring Committee to provide recommendations on whether the study should continue. Patient recruitment and enrollment of the patients in the non-PK group will continue during the IDMC review.

Patients will be followed-up for a period of 1 week after completion of Visit 10. The patients will return to the site for the Follow-up visit at Week 26 to document any adverse events or serious adverse events.

A minimum of 10 surgical procedures comprising major surgeries in a least 5 patients will be targeted to assess control and prevention of bleeding in the surgical setting.

 
Close