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CTRI Number  CTRI/2011/12/002253 [Registered on: 19/12/2011] Trial Registered Retrospectively
Last Modified On: 13/11/2013
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Heptral Observational study in patient with Alcoholic Liver Disease 
Scientific Title of Study   A Prospective Multicenter Observational Study to Characterize the Patient Population with Cholestasis in Chronic Liver Disease due to Alcoholic liver disease receiving Heptral in India. 
Trial Acronym  ALD PMOS SAMe 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
P13-162  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gourdas Choudhuri 
Designation  Head of the Department 
Affiliation  Sanjay Gandhi Post-Graduate Institute of Medical Sciences 
Address  Dept Of Gastroenterology, Raebareli Road, Lucknow 226014

Lucknow
UTTAR PRADESH
226014
India 
Phone  9415017231  
Fax    
Email  gourdas@satyam.net.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Tina Singh 
Designation  Medical Advisor 
Affiliation  Abbott India Limited 
Address  Abbott India Limited - Clinical Operations Sion-Trombay Road, 3-4, Corporate Park,, Mumbai, Maharashtra 400 071 India

Mumbai
MAHARASHTRA
400 071
India 
Phone  02267978877  
Fax    
Email  tina.singh@abbott.com  
 
Details of Contact Person
Public Query  
Name  Dr Tina Singh 
Designation  Medical Advisor 
Affiliation  Abbott India Limited 
Address  Abbott India Limited - Clinical Operations Sion-Trombay Road, 3-4, Corporate Park,, Mumbai, Maharashtra 400 071 India

Mumbai
MAHARASHTRA
400 071
India 
Phone  02267978877  
Fax    
Email  tina.singh@abbott.com  
 
Source of Monetary or Material Support  
Abbott 
 
Primary Sponsor  
Name  Abbott India Limited 
Address  Abbott India Limited - Clinical Operations Sion-Trombay Road, 3-4, Corporate Park,, Mumbai, Maharashtra 400 071 India 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 21  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sateesh Javvaji  Andhra Hospitals  Dept gastroenterology, ,CVR complex, Suryaraopet, Vijayawada - 520002
Krishna
ANDHRA PRADESH 		 9951266448

drjavvaji@gmail.com 
Dr Sunil Gupta  Apex Hspitals Pvt Ltd   Dept gastroenterology, ,SP 4&6, Malviya Industrial Area, Malviya Nagar Jaipur 302017
Jaipur
RAJASTHAN 		 9352027776

drsungu@rediffmail.com 
Dr Gautama Ramakanthan  Ashwini Hospital  1st Floor, Lallan Building, Panch Rasta, P K Road, Mulund (W), Mumbai - 400080
Mumbai
MAHARASHTRA 		 9821012135

gautama.ramakanthan@jupiterhospital.com 
Dr Peeyush Mishra  C.N. Gastrocare & Smile Dental Centre  111/34, Ashok Nagar, Near Shanti Niketan Sweet House, Kanpur - 208012
Kanpur Nagar
UTTAR PRADESH 		 9919240079

peeyushmishra90@gmail.com 
Dr OP Dhakal  City Diagnostic Center  Tadeng Dara Goan, Gangtok - 737102
East
SIKKIM 		 9932232690

dropdhakal@gmail.com 
Dr Harshal Gadhikar  Gadhikars Clinic  Flat No.1, Shivleela Apartment, Opposite DAV School, DP Road, Aundh, Pune - 411007
Pune
MAHARASHTRA 		 9822304983

gadhikarhp@gmail.com 
Dr Mandhir Kumar   Gastro Care   Dept gastroenterology, 42 A Sundar Apartments Pocket GH-10 Pashim Vihar New Delhi 110087
New Delhi
DELHI 		 9811214449

mandhir.2006@gmail.com 
Dr Prashant Bhandarkar  Gastroenterology and Endoscopy Center  128, 1st Floor, Shriman Complex, Dept gastroenterology, Near Lokmat Square, Wardha Road, Nagpur 440012
Nagpur
MAHARASHTRA 		 9823172549

gaec@satyanm.net.in 
Dr P Karthikeyan   Gem Hospital & Research Center  Dept gastroenterology, 45A, Pankaja Mill Road, Ramanathapuram Coimbatore 641041
Coimbatore
TAMIL NADU 		 9841620041

gemhospital@gmail.com 
Dr Joy Vargese  Global Hospitals & Health City  439, Cheran Nagar, Perumbakkam, Chennai - 600100
Chennai
TAMIL NADU 		 9566062200

joyvargese@gmail.com 
Dr Sanjay Kumar  Global Liver & Gastroenterology Center  Dept gastroenterology, E-5,24 Near Arera Petrol Pump Arera Colony Bhopal 462016
Bhopal
MADHYA PRADESH 		 09893056704

sanjaykrgastro@rediffmail.com 
Dr Kaushal Vyas  Gujarat Gastro Group  201, Silver Brook A, Dept gastroenterology, Opp. Doctor House, Ellisbridge, Ahmedabad - 380006
Ahmadabad
GUJARAT 		 07926401918

kaushalv27@yahoo.com 
Dr Saifee Plumber  Hill Way Clinic  Hillway Clinic, Hill-N-Dale, Bandra (W), Mumbai 400 050
Mumbai
MAHARASHTRA 		 9820155780

drsaif_p@yahoo.co.in 
Dr Bhabadev Goswami  Institute of Digestive and Liver Diseases  Dispur Hospitals Pvt Ltd., Ganeshguri, Guwahati - 781006
Kamrup
ASSAM 		 9864094739

bhabadev@rediffmail.com 
Dr Shanthi Vijayaraghavan  Lifeline Multispeciality Hospitals  5/639, Rajiv Gandhi Salai [OMR] , Kandanchavadi , Perungudi, Chennai - 600096
Chennai
TAMIL NADU 		 9840761120

tejasviv@hotmail.com 
Dr Rajeev Mehta  Liver Clinic  203-204, second floor, Narmada Complex, Near Kadiwala School, Ring Road, Surat - 395002
Surat
GUJARAT 		 9879863510

rmgastro@yahoo.com 
Dr Murali Krishna  Manikya Institute of Gastroenterology  MVV Chambers, Dept gastroenterology, Near KGH OP Gate Bus Stop, Maharani Peta, Visakhapatnam - 530002
Visakhapatnam
ANDHRA PRADESH 		 9032032000

muralikrishna63@yahoo.com 
Dr G N Ramesh   PVS Memorial Hospital Limited   PVS Institute of Gastroenterology, Dept gastroenterology, Kaloor Cochin 682017
Ernakulam
KERALA 		 9847034787

gnram@satyam.net.in 
Dr Samir Mohindra  Sanjay Gandhi Post-Graduate Institute of Medical Sciences   SGPGI,Dept of gastroenterology, Raibarely Road, Lucknow 226014
Lucknow
UTTAR PRADESH 		 09839224527

mohindrasamir@yahoo.com 
Dr Indraneel Saha   Sri Aurobindo Seva Kendra   Dept gastroenterology, 1H, Gariahat Road, Jodhpur Park Kolkata 700068
Kolkata
WEST BENGAL 		 9831000396

isjsid@yahoo.co.in 
Dr R Karthikeyan   Sri Balaji Gastro & Endoscopy Center   Dept gastroenterology, 250, Bussy Street, Opposite Kamban Kalai Arangam Pondicherry 605001
Pondicherry
PONDICHERRY 		 9444733454

karthikeyanramasamy@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Alert EC-IEC, Thane, India  Approved 
Institutional Ethics Committee, Global Hospitals & Health City, Chennai, Tamil Nadu, India   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Alcoholic Liver Disease with Intra Hepatic Cholestasis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Heptral  Generic Name: Ademetionine or S-adenosyl-L-methionine Dose & Frequency: As per approved labeled recommendations Duration: Minimum of 6 weeks, can be extended if required based on the investigators discretion 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Chronic liver disease due to alcoholic liver disease as diagnosed by the physician
2) Intrahepatic cholestasis as diagnosed by the physician
3) Age 18 to 65 years.
4) Patients being prescribed Heptral according to local label.
5) Patient’s written authorization to provide data for the study.
 
 
ExclusionCriteria 
Details  1) Contraindications to Heptral treatment including hypersensitivity according to the local label.
2) Pregnancy 1-2 trimester or lactation.
3) Hepatocellular or metastatic liver carcinoma.
4) Severe liver disease including but not limited to ascites, hepatic encephalopathy, hypoalbuminemia, coagulopathy.
5) Other conditions that make the patients participation impossible (by investigator judgment).
6) Patients receiving any hepatotoxic medications
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Demographic data underlying liver disease, diagnostic criteria of intrahepatic cholestasis.
2. Burden of disease in terms of Healthcare utilization & Workload effect
3. Reason(s) for prescribing Heptral 		 After 6 weeks of therapy 
 
Secondary Outcome  
Outcome  TimePoints 
To better understand the effectiveness and the tolerability of ademetionine therapy in the patient population with cholestasis in chronic liver disease due to alcoholic liver disease.  6 weeks treatment 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)
Modification(s)  		 24/09/2011 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   To be published in Indian and International Journals 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

In India, ademetionine (Heptral) is approved for the management of intrahepatic cholestasis and liver diseases. While ademetionine (Heptral) has been available since the past few months in the Indian market, there is limited information on its effectiveness in Indian patients with ALD in terms of improvement in hepatic function profile as well as regarding its safety, tolerability and compliance amongst Indian patients. Also, no data currently exist that characterize patient population with chronic liver disease due to alcoholic liver disease to whom Heptral is prescribed in India and there is limited understanding of the physician’s decision making process at the start the of Heptral treatment. Hence this observational study was planned to include Indian patients with ALD who had been prescribed Heptral by their physicians, in accordance with dosing recommendations mentioned in Heptral package insert, with the objective to gain insight into effectiveness, safety-tolerability and compliance of the drug.

This is a non-interventional, prospective observational study in which Heptral is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication.

 
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