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CTRI Number  CTRI/2026/02/103432 [Registered on: 09/02/2026] Trial Registered Prospectively
Last Modified On: 29/01/2026
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   phase IV single arm, open-label, multicentre study the incidence of treatment emergent adverse events in chemotherapy induced neutropenia patients  
Scientific Title of Study   A phase IV, prospective, single arm, open-label, multicentre study to assess the safety and efficacy of PEG-Neutrogen (pegfilgrastim) in prevention of chemotherapy-induced neutropenia 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
VB066/2022-CT5; version 2 dated 11.11.2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Lakshmi Priyadarshini  
Designation  Principal Investigator 
Affiliation  HCG City Cancer Centre 
Address  Room No 1, OPD, Department of Oncology

Krishna
ANDHRA PRADESH
520002
India 
Phone  9966030988  
Fax    
Email  priyadarshini006@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Hemanth Nandigala 
Designation  Medical Officer 
Affiliation  Virchow Biotech Private Limited 
Address  Room No 1, Department of Clinical Research and Medical Affairs
Madhapur, Hyderabad
Hyderabad
TELANGANA
500081
India 
Phone  9866911717  
Fax    
Email  hnandigala@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Hemanth Nandigala 
Designation  Medical Officer 
Affiliation  Virchow Biotech Private Limited 
Address  Room No 1, Department of Clinical Research and Medical Affairs
Madhapur, Hyderabad
Hyderabad
TELANGANA
500081
India 
Phone  9866911717  
Fax    
Email  hnandigala@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Virchow Biotech Private Limited 
Address  Plot No: 319 & 320, East Avenue, Madhapur, Hyderabad 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr K Lakshmi Priyadarshini  HCG Curie City Cancer Centre  Room No 1, OPD, Department of Oncology, Vijayawada
Krishna
ANDHRA PRADESH 		 09899363358

priyadarshini006@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, HCG Curie city Cancer Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D708||Other neutropenia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  Not applicable as it is a single arm study 
Intervention  Pegfilgrastim 6mg  Administer subcutaneously single dose of PEG-Neutrogen (6 mg) 24 - 30 hrs after chemotherapy  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Male or female patients aged between 18 to 65 years.
2. Patients with histologically confirmed tumors (breast cancer, lung cancer, Non-Hodgkin Lymphoma, ovarian cancer, cervical cancer).
3.Patients who are planned to receive myelosupresive chemotherapy regimen (which is known to induce severe neutropenia).
4. Patients with baseline ANC of greaterthan1.5 x 109/L and platelet count greaterthan 100 x 109/L.
5.Patients with hemoglobin greaterthan9 g/dl; WBC greaterthan3,000/cu mm.
6.Patients with albumin greaterthan 3.0 g/dl.
7.Performance status as per ECOG (Eastern Cooperative Group) score 0, 1 or 2.
8.Patients with life expectancy more than 2 months.
9.Patients scheduled to undergo chemotherapy at least for 3 cycles.
10.Patients who are available for 15 days during each post chemotherapy cycle.
11.Patients who are willing to give the consent.
 
 
ExclusionCriteria 
Details  1.Pregnant and lactating women or patients planning to become pregnant.
2.Known allergic reactions to study medications.
3.Patients with myelodysplastic syndrome, acute lymphoblastic or myeloblastic leukemia, lymophoblastic lymphoma, myeloma or severe pneumonia, hypotension, multi organ dysfunction.
4.Patients with prior exposure to G-CSF or GM-CSF or to its pegylated products.
5. Myelotoxic concomitant treatment such as chloramphenicol, sulphmethoxarate, immunomodulating agents, interferons during 10 days before randomization.
6.Central nervous system metastases.
7.Patients who had an immediate or concurrent exposure to radio therapy and surgery.
8. Abnormal cardiovascular, hepatic and renal laboratory parameters that are deemed to be clinically significant as per investigator.
9.Known cases of sickle cell anemia.
10.History of AIDS, or HIV positive, active hepatitis and active tuberculosis.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Incidence of treatment emergent adverse events.   63 days 
 
Secondary Outcome  
Outcome  TimePoints 
1. Duration of severe neutropenia (ANC lessthan500 cells/µl) in cycle 1.
2. Duration of severe neutropenia (ANC lessthan500 cells/µl) in cycles 2&3.
 		 Day 21, 42, 63 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   02/03/2026 
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="2"
Months="0"
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   A phase IV, prospective, single arm, open-label, multicentre study to assess the safety and efficacy of PEG-Neutrogen (pegfilgrastim) in prevention of chemotherapy-induced neutropenia.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
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