Hepatitis BNCT01772121
Observational Study on Prevalence of Host and Viral Genotypes in Chronic Hepatitis B and Hepatitis C Patients in India
An observational study of Hepatitis B and Hepatitis C, run by Gilead Sciences at 19 sites in India.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B, Hepatitis C
- How many people
- 1,000 participants
- Where
- 19 sitesIndia
- Study dates
- May 2012to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
India19 sites
Civil Hospital, Dawrpui
Aizawl, Mizoram
Manipal Hospitals,98, HAL Airport Road
Bangalore, Karnataka, 560017
Apollo Hospital, Seepat Road
Bilāspur, 495006
Global Hospitals & Health City,# 439, Cheran Nagar, Perumbakkam, Off OMR, Near Shollinganalur
Chennai, Tamil Nadu, 600 100
VGM Hospital, 2100, Trichy Road, Rajalakshmi Mills Stop
Coimbatore, Tamil Nadu, 641005
Digestive Diseases Centre, Beam Diagnostics Premises, Bajrakabati Road [Mali Sahi], Bata Lane
Cuttack, Odhisa, 753001
Medanta-The Medicity,Sector - 38
Gurgaon, Haryana, 122001
Institute of digestive and liver disease,Ganeshguri
Guwahati, Assam, 781 006
Global Hospitals, Lakdi ka Pul
Hyderabad, Andhra Pradesh, 500004
Asian Institute of Gastroenterology , 6-3-661, Somajiguda
Hyderabad, Andhra Pradesh, 500082
Rai Speciality Care Centre, H-6 Janpath,Shyamnagar,Ajmer Road, Sodala
Jaipur, Rajasthan, 342019
Institute of Post Graduate Medical Education And Research,244 A.J.C Bose Road
Kolkata, West Bengal, 700020
Dayanand Medical College & Hospital, Tagore Nagar, Civil Lines
Ludhiana, Punjab, 141001
Diwaliben Mohanlal Mehta Charitable Trust ,1st Foor, Khatau Mansion,95/K Bhulabhai Desai Road
Mumbai, Maharashtra, 400 036
Seth GS Medical College and KEM Hospital, Acharya Donde Marg, Parel
Mumbai, Maharashtra, 400012
Midas Institute of Gastro-enterology, Midas Height,7 - Central Bazar Road,Ramdaspeth
Nagpur, Maharashtra, 440010
Institute of Liver and Biliary Sciences, D-1, Vasant Kunj
New Delhi, New Delhi, 110070
Dharamsi Hospital,Chandni Chowk, South Shivajinagar
Sangli, Mahashtra, 416 416
Liver Clinic, 203-204, Narmada Complex, Near Kadiwala School, Ring Road
Surat, Gujarat, 395002
About this study
Official title: Prevalence of Host and Viral Genotypes in Patients With Chronic Hepatitis B and Hepatitis C Infection in India
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
Read the 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
- Conditions
- Hepatitis B, Hepatitis C
- Keywords
- HBV, HCV, chronic, India, observational study, prevalence,, genotypes, SNPs, viral hepatitis
- Medical subject headings
- Hepatitis B, Hepatitis C, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One Visit
Secondary outcomes (2)
Prevelance of HBV and HCV genotypes
Assess the prevalence of HBV and HCV genotypes and subtypes in different geographic regions of India
Measured: One Visit
Characterize the SNPs present in innate immune factors toll-like receptor 7 (TLR7)
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
Measured: One Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2013 (estimated)
- Study startMay 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01772121
- Sponsor's protocol ID
- GX-US-174-0196
- Status last verified
- Jul 2015
- First submitted
- 17 Jan 2013
- Last updated
- 9 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Host and Viral Genotypes in Patients With Chronic Hepatitis B and Hepatitis C Infection in India
- ClinicalTrials.gov ID
- NCT01772121
- Acronym / sponsor ID
- GX-US-174-0196
- Conditions
- Hepatitis B, Hepatitis C
- Keywords
- HBV, HCV, chronic, India, observational study, prevalence,, genotypes, SNPs, viral hepatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 21 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Prevelance of HBV and HCV genotypes
Time frame: One Visit
Characterize the SNPs present in innate immune factors toll-like receptor 7 (TLR7)
Time frame: One Visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B and Hepatitis C, run by Gilead Sciences at 19 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation in the IL28B rs12979860 SNP (time frame: One Visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2015.