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CTRI Number  CTRI/2018/12/016505 [Registered on: 03/12/2018] Trial Registered Prospectively
Last Modified On: 06/08/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Registry 
Study Design  Other 
Public Title of Study   Chronic Hepatitis C Virus Infection registry to understand the Chronic Hepatitis C Virus Infection 
Scientific Title of Study   Registry to Understand Patient characteristics, Treatment Patterns and Therapy Outcomes in Adults with Chronic Hepatitis C Virus Infection 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
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  Dr Sanjay Hadigal 
Designation  Manager - Medical affairs 
Affiliation  Mylan Pharmaceuticals Private Limited 
Address  Mylan Pharmaceuticals Private Limited, 11th Floor, Prestige Platina Block - 3, Prestige Tech Park, Kadubeesanahalli, Outer Ring Road, Bangalore

Bangalore
KARNATAKA
560087
India 
Phone    
Fax    
Email  Sanjay.Hadigal@mylan.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sanjay Hadigal 
Designation  Manager - Medical affairs 
Affiliation  Mylan Pharmaceuticals Private Limited 
Address  Mylan Pharmaceuticals Private Limited, 11th Floor, Prestige Platina Block - 3, Prestige Tech Park, Kadubeesanahalli, Outer Ring Road, Bangalore

Visakhapatnam
KARNATAKA
560087
India 
Phone    
Fax    
Email  Sanjay.Hadigal@mylan.com  
 
Source of Monetary or Material Support  
Mylan Laboratories Limited Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad – 500096  
 
Primary Sponsor  
Name  Mylan Laboratories Limited 
Address  Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad – 500096 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Belarus
Burkina Faso
Cameroon
India
Indonesia
Kazakhstan
Malaysia
Myanmar
Namibia
Nigeria
Philippines
Thailand
Ukraine
Uzbekistan
Zimbabwe  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Preetam Nath  Kalinga Institute of Medical Sciences(KIMS)   Department of Gastroenterology, Campus No:5, KIIT Road, Patia, Bhubaneswar, Odisha 751024
Cuttack
ORISSA 
9438870743

dr.prretamnath@gmail.com 
Dr Kaushal Madan  Max Smart Super Specialty Hospital  Department of Gastroenterology, 1 , 2 Press Enclave Road, Mandir Marg, Saket, New Delhi, Delhi 110017
South
DELHI 
9958787720

k_madan_2000@yahoo.com 
Dr Karam Romeo Singh  Regional Institute of Medical Sciences  Department of Gastroenterology, Lamphelpat, Imphal, 795004, Manipur
Imphal East
MANIPUR 
9615867047

karamdr@gmail.com 
Dr Akash Shukla  Sion Hospital (Lokmanya Tilak Municipal General Hospital)  Department of Gastroenterology, Dr Babasaheb Ambedkar Rd, RB2 Central Railway Quarters, Sion West, Sion, Mumbai, Maharashtra 400022
Mumbai (Suburban)
MAHARASHTRA 
9869256376

drakashshukla@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Institutional Ethics committee - Kalinga Institute of medical Sciences  Submittted/Under Review 
Institutional Ethics committee for Human Research   Submittted/Under Review 
Max Healthcare Ethics committee  Approved 
RESEARCH ETHICS BOARD, RIMS  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B182||Chronic viral hepatitis C,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients of either sex aged ≥18 years
Patients considered eligible for treatment with DAAs, as per the approved prescribing
information
Patients willing to provide a completed and signed written consent prior to initiation
of treatment 
 
ExclusionCriteria 
Details  Concurrent participation in a HCV clinical trial (except trials not testing investigational
medicinal products)
Patient with a risk of uncertainty regarding returning for follow-up (e.g., patients
planning to move or leave the country in a foreseeable future)
Pregnant or nursing (lactating) women 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prevalence of HCV genotypes, and patterns of anti-HCV treatment strategies in
different countries 
12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Sustained virologic response at 12 and/or 24 weeks after the end of the treatment
with DAA regimens (SVR12 and/or SVR24)
Improvement in hepatic encephalopathy, ascites, gastrointestinal bleeding,
Proportion of participants who need liver transplantation
Number of liver-related deaths during and/or after the treatment
Incidence of adverse events with various DAA treatment regimens
Proportion of participants with virologic failure 
12 months 
 
Target Sample Size   Total Sample Size="2000"
Sample Size from India="300" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/12/2018 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  05/12/2018 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   None Yet.  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Hepatitis C virus (HCV) infection is a liver disease caused by hepatitis C virus. The global prevalence of HCV infection has been found to be 2.5% (177.5 million HCV-infected cases). The HCV prevalence rates in Asia, Africa and Europe are 2.9% (26.9 million cases), 2.8% (111.6 million cases), 1.8% (13 million cases), respectively. The HCV prevalence rate in Central Asia and Eastern Europe that encompass the CIS regions has been noted to be 5.8%, and 3.1%, respectively. A wide variation has been noted in the prevalence rates of HCV infection, and the distribution of the seven genotypes (GT) of HCV among the various regions within each continent. Another epidemiological challenge is the paucity of data related to GT distribution in some extended regions in Asia, Africa, and some of the CIS regions. Several other patient-, government-, payer-, and provider level barriers have also been identified in Asia, Africa, and CIS regions, which may affect the treatment strategies and subsequent outcomes of HCV management. These barriers are further fueled by the lack of adequate documentation of the treatment practices and outcomes in these regions.

 

The need of the hour is the development of a data base of the disease and patient characteristics; genotype distribution; treatment patterns and compliance; and the outcomes of the treatment of HCV infection in Asia, Africa and CIS regions. An understanding of all these parameters would help in addressing the potential barriers to HCV management in these regions.


 
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