| CTRI Number |
CTRI/2008/091/000105 [Registered on: 11/07/2008] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
|
Clinical trial on Hepatitis C |
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Scientific Title of Study
|
A multicentric study of interferon - ribavirin combination therapy and interferon - glycyrrizin combination therapy in the management of chronic hepatitis C |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IRIS ID 2001-0132 |
Other |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof. B. N. Tandon |
| Designation |
|
| Affiliation |
|
| Address |
Chairman,consultant
Metro Hospital
New Delhi
DELHI
India |
| Phone |
26442277 |
| Fax |
|
| Email |
drvivektandon1@rediffmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr. S. K. Acharya |
| Designation |
|
| Affiliation |
|
| Address |
Deptt. Gastro Enterology
AIIMS
New Delhi
DELHI
110029
India |
| Phone |
26589130 |
| Fax |
|
| Email |
subratacharya@gmail.com |
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Details of Contact Person
Public Query
|
| Name |
Dr. Dipali Mukherjee |
| Designation |
|
| Affiliation |
|
| Address |
Division of Epidemiology and communicable diseases
ICMR
New Delhi
DELHI
110029
India |
| Phone |
26589699 |
| Fax |
|
| Email |
dipalimukherji@hotmail.com |
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Source of Monetary or Material Support
|
| Indian Council Of MedicalResearch |
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Primary Sponsor
|
| Name |
ICMR |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
|
| No of Sites = 12 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR. S K Acharya |
AIIMS |
Deptt. of Gastroenterology,Prof & Head-110029
New Delhi
DELHI |
011-26589130
subratacharya2004@yahoo.com |
| Dr. S. Dattagupta |
All India Institute of Medical Sciences, Ansari Nagar |
Professor,Deptt. of Pathology-110029
New Delhi
DELHI |
011-6864851 & 686860
011-6862663
sdgpath@medinst.ernet.in |
| Dr. Deepak N. Amrapukar |
Bombay Hospital & Medical Research Centre, 12, Marine Lines |
Head,Deptt. of Gastroentrology-400020
Mumbai
MAHARASHTRA |
022-2067676
deepakn@bom3vsnl.net.in |
| Dr. Aejaz Habeeb |
Deccan College of Medical Sciences & Allied Hospital, Zafar Garh, Kanchanbagh |
Gastroenterologist,Centre for Liver Research & Diagnostics-500058
Hyderabad
ANDHRA PRADESH |
040-4342954 & 4343129
040-4342954
aejazhabeeb@hotmail.com |
| Dr. S.K.Sarin |
G.B.Pant Hospital |
Professor,Deptt. of Gastoentrology-110002
New Delhi
DELHI |
011-3232013
sksarin@bol.net.in |
| Dr. Abhijit Choudhary |
IGPMER |
Gastroentrologist,Deptt. of Gastroentrology-700020
Kolkata
WEST BENGAL |
033-2485181
033-4751799
achowdhury2002@yahoo.co.in |
| Dr. P.Kar |
MAMC |
Professor,Deptt. of Medicine-110002
New Delhi
DELHI |
011-3230132
PKAR@VSNL.com |
| Dr. Anurag Tondon |
Metro Centre for Liver and Digestive Diseases L-94, Sector-11 |
Gatroentrologist,Deptt. of Gastoenterology-201301
|
918-4519490
918-4524079
dranuragtandon@yahoo.com |
| Dr. M.D.Gupte |
National Institute of Epidemiology (ICMR), Mayor V.R.Ramanathan Road, Chennai |
Director,Deptt. of Epidemiology-600031
Chennai
TAMIL NADU |
044-8261642 & 8265308
044-8264963
mohangupted@yahoo.com |
| Dr. Vidya Arankalle |
National Institute of Virology, 20-A, Dr. Ambedkar Road |
Deputy Director & Head,Hepatitis Division-411001
Pune
MAHARASHTRA |
020-6127301
020-6122669 & 6123679
varankalle@yahoo.com |
| Dr. Y.K.Chawla |
PGIMER |
Professor & Head,Deptt. of Hepatology-160012
Chandigarh
CHANDIGARH |
0172-747585
ykchawla@gmail.com |
| Dr. G. Choudhuri |
Sanjay Gandhi Postgraduate Institute of Medical Sciences |
Addl. Professor,Deptt. of Gastroentrology-226014
Lucknow
UTTAR PRADESH |
0522-440700
0522-440973
gc@sgpgi.ac.in |
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Details of Ethics Committee
|
| No of Ethics Committees= 12 |
| Name of Committee |
Approval Status |
| AIIMS, New Delhi |
Approved |
| Bombay Hospital& Medical Research Centre,Mumbai |
Approved |
| DCMS&Allied Hospital, Hyderabad |
Approved |
| Ethics Committees of the respective participating Instts |
Approved |
| G B Pant Hospital,New Delhi |
Approved |
| IGPMER,KOLKAtA |
Approved |
| MAMC, New Delhi |
Approved |
| MCL&DD, Noida |
Approved |
| NIE, Chennai |
Approved |
| NIV,Pune |
Approved |
| PGI, Chandigarh |
Approved |
| SGPGI,Lucknow |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Hepatitis C , |
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Interferon and glycyrrhizin |
Interferon a2b 3 MU/d and Glycyrrhizin 250mg |
| Intervention |
interferon and Ribavirin |
[Interferon a 2b 3MU/d and Ribavirin 1000mg/d |
|
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
AL T > 60 IU / L
Histological activity index (HAl) > 3
Willing to be treated on an out-patient basis for 24 weeks
Willing to give blood specimens initially, on days 2, 4 & 8 and subsequently at 4-weekly intervals during 24-wk treatment period and once in 12 weeks during the 24-wk follow-up period
Willing to undergo liver biopsies thrice i.e., initially, at week 24 (optional) and after completion of F. U (week 48)
Etiology of HCV
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| ExclusionCriteria |
| Details |
Fibrosis score> 5 (as per Knodell's scoring system)
Serum bilirubin >3.0 mg%
Prothrombin time 6 seconds prolonged than control
Coronary artery, respiratory or any other disease with expected survival less than one year
Major depressive illness, cytopenias, hyperthyroidism, renal transplantation, and evidence of auto-immune disease, Wilson's disease or co-infection with HIV
Multiple transfusions like thalassemics and haemophiliacs
Use of intravenous or oral narcotic drugs
Receiving immuno-suppressive therapy for other associated illnesses
Interferon therapy during the past 6 months
Use of known hepatotoxic drugs, oral contraceptives, herbal medicines or cortico-steroids during the past 3 months
Alcoholism [2 drinks (80 gm) per day for more than one year]
Pregnancy
Lactating mother with infant aged less than 6 months |
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Method of Generating Random Sequence
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Permuted block randomization, fixed |
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Method of Concealment
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Centralized |
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Blinding/Masking
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Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| Biochemical,histopathological and virological |
Biochemical at 0 day,4,24,28 &48 wks Histopathological at 0 day,48 wks Virological atDays 0,2,4,8 and at4,24,28,48 and 72 wks |
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Secondary Outcome
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| Outcome |
TimePoints |
| NIL |
NIL |
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Target Sample Size
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Total Sample Size="125"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 3 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/04/2002 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="3"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
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Completed |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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This study is a Multi-centric randomized controlled trial comparing two treatment regimens [Interferon a 2b 3MU/d and Ribavirin 1000mg/d (I+R) vs. Interferon a2b 3 MU/d and Glycyrrhizin 250mg (I+G)] in CH-C. Viral, host characteristics and therapeutic responses were assessed.The study was carried out in twelve centres in India andperiod was February 2002 to May 2005. One hundred and thirty one patients meeting the inclusion criteria were randomized to I+G (n = 64) or I+R (n = 67). About 85% (I+G = 53, I+R = 58) completed 6 months of treatment and 99 (I+G = 46, I+R = 53) completed 6 months of follow-up after completion of treatment. HCV Genotype 3 was the major type detected (71%) in patients. The mean viral load (106 copies/ml), histological activity index and fibrosis stage for all patients were 0.59 + 0.93, 5 + 2 and 2 + 1.5 respectively. HCV infection with genotypes 1 and 4 was more prevalent among males than in females (33.8% vs. 8.3%); average BMI was more in patients with higher viral load than lower viral load (26.9 vs. 23.9 Kg/m2); more females than males (64.5% vs. 41.8%) and more patients aged > 40 years than aged < 40 years (58.9% vs. 32.1%) had fibrosis score ≥ 3 (p < 0.01). The rapid viral response (RVR), end of treatment viral response (ETVR), sustained virological response (SVR) and histological improvement among the two treatment arms I+G and I+R by per-protocol (PP) analysis were 78.6% vs. 86.2%, 78.4% vs. 84.9%, 58.7% vs. 72.9% and 62.5% vs. 64.4% respectively (p > 0.19). I+G treatment is associated with lower frequencies of leucopenia (2% vs. 17%, p < 0.01) and decrease in hemoglobin (8% vs. 40%, p < 0.001) as compared to treatment with I+R.
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