Observational Study on Prevalence of Host and Viral Genotypes in Chronic Hepatitis B and Hepatitis C Patients in India
Prevalence of Host and Viral Genotypes in Patients With Chronic Hepatitis B and Hepatitis C Infection in India
1 other identifier
observational
1,000
1 country
19
Brief Summary
This study will define the substantial disease burden associated with viral hepatitis in India, and provide a foundation to understand the host and viral determinants of disease pathogenesis that may ultimately impact treatment decisions and outcome
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2012
Shorter than P25 for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 17, 2013
CompletedFirst Posted
Study publicly available on registry
January 21, 2013
CompletedJuly 9, 2015
July 1, 2015
5 months
January 17, 2013
July 7, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Variation in the IL28B rs12979860 SNP
Characterize the variation in the IL28B rs12979860 SNP that exists among patients with chronic hepatitis C or chronic hepatitis B infection, in the different geographic regions of India
One Visit
Secondary Outcomes (2)
Prevelance of HBV and HCV genotypes
One Visit
Characterize the SNPs present in innate immune factors toll-like receptor 7 (TLR7)
One Visit
Study Arms (2)
HCV Cohort
A total of 1000 subjects were enrolled in the study and of that 500 subjects had a diagnosis of chronic HCV infection
HBV Cohort
A total of 1000 subjects were enrolled in the study and of that 500 subjects had a diagnosis of chronic HBV infection
Eligibility Criteria
A total of 1000 subjects will be enrolled in the study. Of these, it is planned that approximately 500 subjects will have a diagnosis of chronic HCV infection and approximately 500 subjects will have a diagnosis of chronic HBV infection.Subjects knowingly co-infected with HCV/HBV or HIV may not participate in the study
You may qualify if:
- Willing and able to provide written informed consent
- Male or female, age \>= 18
- Willing and able to comply with the visit procedure
- Prior diagnosis of chronic HCV infection or chronic HBV infection
You may not qualify if:
- History of difficulty with blood collection and/or poor venous access for the purposes of phlebotomy
- History of bleeding disorder
- Blood loss requiring transfusion or \> 3 g/dL decrease in hemoglobin within 4 days of the visit
- Knowingly co-infected with HCV/HBV or with HIV
- Currently undergoing therapy for chronic hepatitis C or chronic hepatitis B
- Currently receiving treatment with any other investigational agent or device -- Enrolled in another clinical study evaluating a treatment or procedure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (19)
Global Hospitals, Lakdi ka Pul
Hyderabad, Andhra Pradesh, 500004, India
Asian Institute of Gastroenterology , 6-3-661, Somajiguda
Hyderabad, Andhra Pradesh, 500082, India
Institute of digestive and liver disease,Ganeshguri
Guwahati, Assam, 781 006, India
Liver Clinic, 203-204, Narmada Complex, Near Kadiwala School, Ring Road
Surat, Gujarat, 395002, India
Medanta-The Medicity,Sector - 38
Gurgaon, Haryana, 122001, India
Manipal Hospitals,98, HAL Airport Road
Bangalore, Karnataka, 560017, India
Diwaliben Mohanlal Mehta Charitable Trust ,1st Foor, Khatau Mansion,95/K Bhulabhai Desai Road
Mumbai, Maharashtra, 400 036, India
Seth GS Medical College and KEM Hospital, Acharya Donde Marg, Parel
Mumbai, Maharashtra, 400012, India
Midas Institute of Gastro-enterology, Midas Height,7 - Central Bazar Road,Ramdaspeth
Nagpur, Maharashtra, 440010, India
Dharamsi Hospital,Chandni Chowk, South Shivajinagar
Sangli, Mahashtra, 416 416, India
Civil Hospital, Dawrpui
Aizawl, Mizoram, India
Institute of Liver and Biliary Sciences, D-1, Vasant Kunj
New Delhi, New Delhi, 110070, India
Digestive Diseases Centre, Beam Diagnostics Premises, Bajrakabati Road [Mali Sahi], Bata Lane
Cuttack, Odhisa, 753001, India
Dayanand Medical College & Hospital, Tagore Nagar, Civil Lines
Ludhiana, Punjab, 141001, India
Rai Speciality Care Centre, H-6 Janpath,Shyamnagar,Ajmer Road, Sodala
Jaipur, Rajasthan, 342019, India
Global Hospitals & Health City,# 439, Cheran Nagar, Perumbakkam, Off OMR, Near Shollinganalur
Chennai, Tamil Nadu, 600 100, India
VGM Hospital, 2100, Trichy Road, Rajalakshmi Mills Stop
Coimbatore, Tamil Nadu, 641005, India
Institute of Post Graduate Medical Education And Research,244 A.J.C Bose Road
Kolkata, West Bengal, 700020, India
Apollo Hospital, Seepat Road
Bilāspur, 495006, India
Biospecimen
A portion of the blood drawn at the study visits will be frozen and stored. Stored blood samples may be used by the Sponsor or its research partners for HCV/HBV genotyping/phenotyping assays (as applicable) or their development or for retesting the amount of HCV/HBV in the blood. At the conclusion of this study, these samples may be retained in storage by Gilead Sciences or a designee for a period up to 10 years
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2013
First Posted
January 21, 2013
Study Start
May 1, 2012
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
July 9, 2015
Record last verified: 2015-07