Observational Study on Prevalence of Host and Viral Genotypes in Chronic Hepatitis B and Hepatitis C Patients in India
This study has been completed.
Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01772121
First received: January 17, 2013
Last updated: July 7, 2015
Last verified: July 2015
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Purpose
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
| Condition |
|---|
|
Hepatitis B Hepatitis C |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Prevalence of Host and Viral Genotypes in Patients With Chronic Hepatitis B and Hepatitis C Infection in India |
Resource links provided by NLM:
Further study details as provided by Gilead Sciences:
Primary Outcome Measures:
- Variation in the IL28B rs12979860 SNP [ Time Frame: One Visit ]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
Secondary Outcome Measures:
- Prevelance of HBV and HCV genotypes [ Time Frame: One Visit ]Assess the prevalence of HBV and HCV genotypes and subtypes in different geographic regions of India
- Characterize the SNPs present in innate immune factors toll-like receptor 7 (TLR7) [ Time Frame: One Visit ]Characterize the SNPs present in innate immune factors TLR7 (rs3853839, rs179008); TLR9 (rs41308230, rs5743844 ); RIG-I (rs11795404, rs10813831) and NOD2 (rs2067085, rs2066842), in patients with chronic hepatitis C or chronic hepatitis B in the different geographic regions of India
Biospecimen Retention: Samples With DNA
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
| Enrollment: | 1000 |
| Study Start Date: | May 2012 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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
|
Detailed Description:
The overall goal of this study is to correlate the host and viral genetics of patients infected with viral hepatitis with their clinical presentation. This study will provide the first nation-wide estimate of key host genetic polymorphisms associated with immune response, such as in the IL28B gene locus which has been associated with treatment outcomes in hepatitis C. Characterization of HCV and HBV viral genotypes and sub-types across different geographic regions will allow for an exploration of associations between host and viral genotypes. Another objective of this study is to identify co-morbid illness and metabolic factors that are associated with chronic liver disease due to viral hepatitis. Finally, this survey will explore patient awareness of their disease, risk factors for disease progression, and their treatment options
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
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
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01772121
Please refer to this study by its ClinicalTrials.gov identifier: NCT01772121
Locations
| India | |
| Global Hospitals, Lakdi ka Pul | |
| Hyderabad, Andhra Pradesh, India, 500004 | |
| Asian Institute of Gastroenterology , 6-3-661, Somajiguda | |
| Hyderabad, Andhra Pradesh, India, 500082 | |
| Institute of digestive and liver disease,Ganeshguri | |
| Guwahati, Assam, India, 781 006 | |
| Liver Clinic, 203-204, Narmada Complex, Near Kadiwala School, Ring Road | |
| Surat, Gujarat, India, 395002 | |
| Medanta-The Medicity,Sector - 38 | |
| Gurgaon, Haryana, India, 122001 | |
| Manipal Hospitals,98, HAL Airport Road | |
| Bangalore, Karnataka, India, 560017 | |
| Diwaliben Mohanlal Mehta Charitable Trust ,1st Foor, Khatau Mansion,95/K Bhulabhai Desai Road | |
| Mumbai, Maharashtra, India, 400 036 | |
| Seth GS Medical College and KEM Hospital, Acharya Donde Marg, Parel | |
| Mumbai, Maharashtra, India, 400012 | |
| Midas Institute of Gastro-enterology, Midas Height,7 - Central Bazar Road,Ramdaspeth | |
| Nagpur, Maharashtra, India, 440010 | |
| Dharamsi Hospital,Chandni Chowk, South Shivajinagar | |
| Sangli, Mahashtra, India, 416 416 | |
| Civil Hospital, Dawrpui | |
| Aizawl, Mizoram, India | |
| Digestive Diseases Centre, Beam Diagnostics Premises, Bajrakabati Road [Mali Sahi], Bata Lane | |
| Cuttack, Odhisa, India, 753001 | |
| Dayanand Medical College & Hospital, Tagore Nagar, Civil Lines | |
| Ludhiana, Punjab, India, 141001 | |
| Rai Speciality Care Centre, H-6 Janpath,Shyamnagar,Ajmer Road, Sodala | |
| Jaipur, Rajasthan, India, 342019 | |
| Global Hospitals & Health City,# 439, Cheran Nagar, Perumbakkam, Off OMR, Near Shollinganalur | |
| Chennai, Tamil Nadu, India, 600 100 | |
| VGM Hospital, 2100, Trichy Road, Rajalakshmi Mills Stop | |
| Coimbatore, Tamil Nadu, India, 641005 | |
| Institute of Post Graduate Medical Education And Research,244 A.J.C Bose Road | |
| Kolkata, West Bengal,, India, 700020 | |
| Apollo Hospital, Seepat Road | |
| Bilaspur, India, 495006 | |
| Institute of Liver and Biliary Sciences, D-1, Vasant Kunj | |
| New Delhi, India, 110070 | |
Sponsors and Collaborators
Gilead Sciences
More Information
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01772121 History of Changes |
| Other Study ID Numbers: |
GX-US-174-0196 |
| Study First Received: | January 17, 2013 |
| Last Updated: | July 7, 2015 |
Keywords provided by Gilead Sciences:
|
HBV, HCV, chronic, India, observational study, prevalence, genotypes, SNPs, viral hepatitis |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Hepatitis, Chronic Hepatitis B Hepatitis B, Chronic Liver Diseases Digestive System Diseases |
Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Hepadnaviridae Infections DNA Virus Infections |
ClinicalTrials.gov processed this record on May 24, 2017