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CTRI Number  CTRI/2019/11/021975 [Registered on: 13/11/2019] Trial Registered Prospectively
Last Modified On: 08/01/2021
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Phase IV clinical trial to know the side effects and response of Daclatasvir 60 mg & Sofosbuvir 400 mg tablets in patients with Chronic Hepatitis C genotype 3 infection  
Scientific Title of Study   An open label multicenter Phase IV clinical trial to evaluate the safety and efficacy of the Fixed Dose Combination of Daclatasvir 60 mg & Sofosbuvir 400 mg Tablets in patients with Chronic Hepatitis C genotype 3 infection  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
HEPCNATPL-4, Version: 2, Date: 22/10/2018  Protocol Number 
Version No. 1, dated: 05 Sep 2018  DCGI 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dharmesh Kapoor 
Designation  Senior Consultant Hepatologist 
Affiliation  Global Hospitals 
Address  Gleneagles Global Clinical Research Services, Global Hospitals 6-1-1070/1 to 4 Lakdikapool Hyderabad
Global Hospitals, 6-1-1070/1 to 4 Lakdikapul Hyderabad 500004
Hyderabad
TELANGANA
500004
India 
Phone    
Fax    
Email  dharmesh_kapoor@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dharmesh Kapoor 
Designation  Senior Consultant Hepatologist 
Affiliation  Global Hospitals 
Address  Gleneagles Global Clinical Research Services, Global Hospitals 6-1-1070/1 to 4 Lakdikapool Hyderabad
Global Hospitals, 6-1-1070/1 to 4 Lakdikapul Hyderabad 500004
Hyderabad
TELANGANA
500004
India 
Phone    
Fax    
Email  dharmesh_kapoor@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Dharmesh Kapoor 
Designation  Senior Consultant Hepatologist 
Affiliation  Global Hospitals 
Address  Gleneagles Global Clinical Research Services, Global Hospitals 6-1-1070/1 to 4 Lakdikapool Hyderabad
Global Hospitals, 6-1-1070/1 to 4 Lakdikapul Hyderabad 500004
Hyderabad
TELANGANA
500004
India 
Phone    
Fax    
Email  dharmesh_kapoor@yahoo.com  
 
Source of Monetary or Material Support  
Natco Pharma Limited 
 
Primary Sponsor  
Name  Natco Pharma Limited 
Address  Natco House Road No 2 Banjara Hills Hyderabad 500034  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dharmesh Kapoor  Gleneagles Global Clinical Research Services  Global Hospitals 6-1-1070/1 to 4 Lakdikapool Hyderabad 500004
Hyderabad
TELANGANA 		 09849439407

dharmesh_kapoor@hotmail.com 
Dr Abhijit Chowdhury  IPGME&R/SSKM Hospital  Dept. of Hepatology School of Digestive & Liver Disease IPGME&R/SSKM Hospital 244 AJC Bose Road Kolkata 700020
Kolkata
WEST BENGAL 		 00919830330503

bidyut.muk2009@gmail.com 
Dr Madhumita Premkumar  Post Graduate Institute of Medical Education and Research  Department of Hepatology   Nehru Hospital PGIMER  Sector12 Chandigarh 160012
Chandigarh
CHANDIGARH 		 9540951061

drmadhumitap@gmail.com 
Dr K Romeo Singh   Regional Institute of Medical Sciences  Department of Medicine Regional Institute of Medical Sciences Imphal Manipur 795004
Imphal West
MANIPUR 		 6909364005

karamdr@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institute of Postgraduate Medical Education and Research Office of the Dean  Approved 
Institutional Ethics Committee  Approved 
Research Ethics Committee Board RIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B182||Chronic viral hepatitis C,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hepcinat Plus   (Daclatasvir 60 mg + Sofosbuvir 400 mg) Tablets Route: oral Frequency: daily once Total Duration: 24 weeks  
Comparator Agent  NOT Applicable  NOT Applicable 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Confirmed chronic HCV with genotype 3 infection (positive HCV genotyping test)

2.Patients with the following haematological and biochemical laboratory variables: A neutrophil count of 1.5 x 109/L, haemoglobin concentration of 11 g/dl or higher in women or 12 g/dl or higher in men, a platelet count of greater than 90 x 109/L, total bilirubin within two times the upper limit of normal (21 µmol/L), ALT less than or equal to 10 times the upper limit of normal (ULN), AST less than or equal to 10 times the ULN

3.Patients who are willing and able to provide written informed consent

4.Patients must follow adequate birth control measures from the date of screening to at least 7 months from the date of stopping the study drug

5.Patients with Compensated liver cirrhosis
 
 
ExclusionCriteria 
Details  1. Patients with Hepatocellular Carcinoma
2. Patients who are pregnant or lactating
3.Patients diagnosed with HIV- I & II Hepatitis B Virus infection, psychiatric illness, unstable pulmonary or cardiac disease seizure disorder or other serious comorbid disorders
4.Decompensated Cirrhosis
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in the HCV RNA levels  week 1 week 12 and week 24 
 
Secondary Outcome  
Outcome  TimePoints 
Adverse event monitoring   week 1 and week 24 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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)   20/11/2019 
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="1"
Months="6"
Days="12" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  		 NOt Applicable 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

The proposed study is an open label, phase IV clinical trial to evaluate the efficacy and safety of Daclatasvir 60 mg & Sofosbuvir 400 mg Tablets in patients with Chronic Hepatitis C genotype 3 infection. Study drugs are formulated as Fixed Dose Combination. 

 

Chronic infection with hepatitis C virus (HCV) genotype 3 is common throughout the world

and remains a significant disease burden for many patients. Infection with HCV genotype 3 has been associated with an increased risk of progression to cirrhosis, as well as development of steatosis or hepatocellular carcinoma (HCC), compared with other HCV genotypes. DCGI has approved the FDC.

 

Daclatasvir 60 mg and Sofosbuvir 400 mg administered to patients who are chronically infected with HCV genotype 3, twelve-week regimen of Daclatasvir plus Sofosbuvir achieved sustained virological response of 90% was achieved. In this phase IV study Fixed Dose combination of Daclatasvir 60 mg and Sofosbuvir 400 mg will be used.

 
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