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CTRI Number  CTRI/2016/11/007454 [Registered on: 08/11/2016] Trial Registered Retrospectively
Last Modified On: 10/11/2016
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   A follow up, long term Registry of Subjects Treated in Chronic Hepatitis B Infection 
Scientific Title of Study   A Long Term Follow-up Registry of Subjects Treated in A Gilead-Sponsored Trial in Subjects with Chronic Hepatitis B Infection 
Trial Acronym  GS-US-330-1508 
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 Vikram Vora 
Designation  Medical Monitor 
Affiliation  Klinera Corporation India 
Address  Klinera Corporation India 401 Hill View Industrial Estate LBS Marg Ghatkopar West Mumbai 400086 MAHARASHTRA India Mumbai MAHARASHTRA 400086 India

Mumbai
MAHARASHTRA
400086
India 
Phone  02225004573  
Fax  02225004588  
Email  vvora@klinera.com  
 
Details of Contact Person
Public Query  
Name  Pravin Moily 
Designation  Clinical Project Manager 
Affiliation  Klinera Corporation India 
Address  Klinera Corporation India 401 Hill View Industrial Estate LBS Marg Ghatkopar West Mumbai 400086 MAHARASHTRA India Mumbai MAHARASHTRA 400086 India

Mumbai
MAHARASHTRA
400086
India 
Phone  02225004573  
Fax  02225004588  
Email  pmoily@klinera.com  
 
Source of Monetary or Material Support  
Gilead Sciences Inc 333 Lakeside Drive Foster City, CA 94404  
 
Primary Sponsor  
Name  Gilead Sciences Inc 
Address  333 Lakeside Drive Foster City, CA 94404  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Australia
Canada
France
Germany
Greece
Hong Kong
India
Italy
Netherlands
Poland
Portugal
Romania
Singapore
Spain
Taiwan
Turkey
United Kingdom
United States of America  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sachin Palnitkar  Global Hospital, Hyderabad  Lakdikapul, Hyderabad, Dept of Gastroenterology, 4th floor, Telangana 500004.
Hyderabad
ANDHRA PRADESH 		 919966789779
914023233166
palnitkarsachin@gmail.com 
Dr Suparna Pal  Institute of Post Graduate Medical Education and Research, SSKM Hospitals  Institute of Post Graduate Medical Education and Research, SSKM Hospitals, Dept of Gastroenterology, 4th floor, 244, A. J. C. Bose Road, Kolkata- 700020, West Bengal, India
Kolkata
WEST BENGAL 		 919434057697
912612494296
suparnapal2007@yahoo.com 
Dr Anand Totagi  Midas Multispeciality Hospital Pvt. Ltd  Midas Heights, Dept of Gastroenterology, 3rd Floor, Shriwardhan Complex, Wardha Road, Ramdaspeth, Ramdaspeth, Nagpur, Maharashtra 440010.
Nagpur
MAHARASHTRA 		 919840783025
911722442536
53anand@yahoo.co.in 
Dr Saumin Shah  Nirmal Hospital Private Limited  Nirmal Hospital Private Limited, Dept of Gastroenterology,Centre Point, Ring Road, Near Kadiwala School, Surat, Gujarat 395002.
Surat
GUJARAT 		 919408042224
912612494296
drsauminshah@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Institute of Post Graduate Medical Education and Research, SSKM Hospitals,Ethics Committee, Kolkata- Dr. Suparna Pal  Submittted/Under Review 
Institutional Ethics Committee, Global Hospital- Dr. Sachin Palnitkar  Approved 
Midas Multispeciality Hospital Ethics Committee, Dr. Anand Totagi  Approved 
Nirmal Hospital Private Limited Ethics Committee, Surat; Dr. Saumin Shah   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Notified 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Chronic hepatitis B virus (HBV) HBeAg–negative infection ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Must have participated in a Gilead-sponsored CHB study no more than 120 days prior to Baseline (Day 1), except for subjects from previous Gilead-sponsored study number GS-US-174-0149, who will have up to one year from their last visit in that protocol
2. Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
3. Must be willing and able to comply with the visit schedule and study requirements.
4. Must have documented HBV DNA < 2,000 IU/mL at time of Screening visit, which shall occur no later than 1 year post last study visit in GS-US-174-0149
5. Must have documented HBsAg negative status anytime during participation in GS-US-174-0149 regardless of ongoing HBV treatment.
 
 
ExclusionCriteria 
Details  1.Patient participating or planning to participate in another clinical study with an investigational agent
2.History or current presence of clinically-significant illness or any other major medical disorder that may interfere with subject follow-up, assessments or compliance with the protocol.
3.Believed by the Study Investigator to be inappropriate for study participation for any reason not otherwise listed.

For subjects from previous Gilead-sponsored study number GS-US-174-0149 meeting Inclusion Criteria #4, subjects who meet the following exclusion criteria are not eligible to participate in the study:
4. Received TDF monotherapy either as part of GS-US-174-0149 Arm C (TDF Monotherapy arm) or for TDF retreatment, and have taken any HBV antiviral therapy since completion of GS-US-174-0149
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. For subjects who are HBsAg positive at Baseline:The proportion of subjects with serum HBsAg decline ≥ 0.5 log10 IU/ml from Baseline at
Week 48.
2. For subjects who are HBsAg negative at Baseline:The proportion of subjects who remain HBsAg negative at Week 48 		 Week 48 
 
Secondary Outcome  
Outcome  TimePoints 
.The proportion of subjects with serum HBsAg decline ≥ 0.5 log10 IU/ml from Baseline at Week 144.
2.The proportion of subjects who achieve HBsAg loss at week 48, 144.
3.The proportion of subjects who remain HBsAg negative at week 144.
4.Proportions of subjects with HBeAg loss and seroconversion at week 48.
5.Proportions of subjects with HBeAg loss and seroconversion at week 144.
6.For subjects on treatment with OAV anti-HBV, the proportion of subjects with HBV-DNA LLOQ at week 48,96,144. 		 Week 48, 96,144  
 
Target Sample Size   Total Sample Size="7"
Sample Size from India="7" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   18/03/2016 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The purpose of this study is to evaluate a long term follow-up of subjects with Chronic Hepatitis B Infection at  Baseline and at Week 12,24,48,72,96,120,144.  

 
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