| 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 |
|
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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
|
|
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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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B182||Chronic viral hepatitis C, |
|
|
Intervention / Comparator Agent
|
|
|
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. |