FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2010/091/000234 [Registered on: 01/04/2010]
Last Modified On:
Post Graduate Thesis   
Type of Trial   
Type of Study    
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Treatment of hepatitis B carriers by immune cell therapy maturing their own WBC(CD14) cells for treatment 
Scientific Title of Study   Phase I treatment, single centric, randomized, intervention study on chronic HBV infected patients by autologous dendritic cell therapy in lowering serum viral load.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Jamal A. Khan 
Designation   
Affiliation   
Address  J-3,
Sector 41
Not Applicable
N/A
201303
India 
Phone  01202500111  
Fax  01204317902  
Email  jamal@dendriticcellresearch.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Sharmin Yaqin 
Designation   
Affiliation  Director, Institute of Cellular Therapies Private Limited 
Address  J-3
Sector 41
Not Applicable
N/A
201303
India 
Phone  01202500195  
Fax  01204317902  
Email  sharmin@dendriticcellresearch.com  
 
Details of Contact Person
Public Query  
Name  Ms. Kirti Singh 
Designation   
Affiliation   
Address  J-3
Sector 41
Not Applicable
N/A
201303
India 
Phone  01202500195  
Fax  01204317902  
Email  kirti@dendriticcellresearch.com  
 
Source of Monetary or Material Support  
Institute of Cellular Therapies Private Limited 
 
Primary Sponsor  
Name  Institute of Cellular Therapies Private Limited 
Address   
Type of Sponsor   
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr. Sharmin Yaqin  Institute of Cellular Therapies Private Limited  J-3, Sector 41,-201303

 		 01202500195
01204317902
sharmin@dendriticcellresearch.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ICT  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Chronic Hepatitis B Carriers having HBSAg positive status, HBV DNA positive status,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ex vivo cultured CD14 cells  Monthly doses for six months each dose comprising of about 1 million matured dendritic cells 
Comparator Agent  Normal Saline  10 ml given by iv infusion 
 
Inclusion Criteria  
Age From   
Age To   
Gender   
Details  Inclusion Criteria Adults Males or females aged above 18 till 60 years of age with diagnosis of chronic hepatitis B infection for past 6 months, proven by elisa and pcr test HBSAg positivity >3000 copies of DNA by PCR (quantitative estimation) 
 
ExclusionCriteria 
Details  serum bilirubin >3mg% pregnancy active tuberculosis HIV seropositivity 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Other 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Safety and tolerability, assessed by adverse events. The type of AE(S), Number of AE(S) and proportion of Patients with AE(S)  Baseline, 1st day, seventh day, one month,three months and six months 
 
Secondary Outcome  
Outcome  TimePoints 
Serum Level of HBSAg(quantitative analysis), HBV DNA estimation by PCR (quantitative status- whether it has reached to less than 300 per ml of serum.  3 motnhs and 6 months 
 
Target Sample Size   Total Sample Size="20"
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" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/04/2010 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)   
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This study is a randomised,single blinded,parallel group,single centeric trial determining safety and efficacy of autologous dendritic cells (about 1 million in number) for 6 months in 10 chronic Hepatitis B carriers.The objective of this study is to see whether administartion of autologous dendritic cells at doses of 1 million cells via interavenous route is: 1. safe. 2. To find out efficacy of theraputic dose. 3. Can clear infection of HBV DNA. Carriers will be evaluated at 7 days for safety, 1 month for safety 3 month for safety and efficacy, 6 month for safety and efficacy parameters. 
Close