| CTRI Number |
CTRI/2017/08/009547 [Registered on: 30/08/2017] Trial Registered Prospectively |
| Last Modified On: |
17/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
An Observational Post Marketing study to check the Safety and Effectiveness of Sofosbuvir based treatment in Patients with Chronic Hepatitis C |
|
Scientific Title of Study
|
An observational, practice based, open label, prospective, multicenter, post marketing
surveillance to assess safety and efficacy of sofosbuvir as a component of a combination
antiviral treatment regimen for the treatment of patients with chronic hepatitis C (CHC) virus
infection. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CP/14/15 Version 01 Dated 28/06/2017 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajaykumar B Malle |
| Designation |
General Manager Clinical Trials |
| Affiliation |
Accutest Research Laboratories (I) Pvt.Ltd |
| Address |
A-77, Khairne MIDC, TTC Industrial Area,
Khairne, Navi Mumbai
Mumbai
MAHARASHTRA
400709
India |
| Phone |
02227780718 |
| Fax |
|
| Email |
ajay.malle@accutestglobal.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajaykumar B Malle |
| Designation |
General Manager Clinical Trials |
| Affiliation |
Accutest Research Laboratories (I) Pvt.Ltd |
| Address |
A-77, Khairne MIDC, TTC Industrial Area,
Khairne, Navi Mumbai
Mumbai
MAHARASHTRA
400709
India |
| Phone |
02227780718 |
| Fax |
|
| Email |
ajay.malle@accutestglobal.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hiren Gandhecha |
| Designation |
Project Manager Clinical Trials |
| Affiliation |
Accutest Research Laboratories (I) Pvt.Ltd |
| Address |
Opp. The Grand Bhagwati,
S.G. Highway,
Bodakdev, Ahmedabad
Ahmadabad
GUJARAT
380059
India |
| Phone |
07940231600 |
| Fax |
|
| Email |
hiren.gandhecha@accutestglobal.com |
|
|
Source of Monetary or Material Support
|
| Cipla Ltd., Cipla House, Peninsula Business Park
Ganpatrao Kadam Marg, Lower Parel,
Mumbai 400013 |
|
|
Primary Sponsor
|
| Name |
Cipla Ltd |
| Address |
Cipla House, Peninsula Business Park
Ganpatrao Kadam Marg, Lower Parel,
Mumbai – 400013 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kaushal Madan |
Artemis Hospital |
Department of Gastroenterology, Sector 51, Gurugram -122001
Gurgaon
HARYANA |
09958787720
k_madan_2000@yahoo.com |
| Dr Ajit Sood |
Dayanand Medical College and Hospital |
Department of Gastroenterology, Rajpura Road, Near Rose Garden, Tagore Nagar, Civil Lines, Ludhiana-141001
Ludhiana
PUNJAB |
09815400718
ajitsood10@gmail.com |
| Dr Abhijit Chandra |
King George Medical University Gandhi Memorial and Associated Hospital |
Department of Gastroenterology,Shah Mina Road, Chowk, Lucknow-226003
Lucknow
UTTAR PRADESH |
09335920302
abhijitchandra@hotmail.com |
| Dr Santosh Hajare |
KLES Dr Prabhakar Kore Hospital and MRC |
Department of Gastroenterology, Nehru Nagar, Belgaum- 590010
Belgaum
KARNATAKA |
09448111913
drsantoshhajare@gmail.com |
| Dr Vineet kumar Shukla |
KRM Hospital and Research Center |
3/92-93, Vijayant Khand, Gomati Nagar, Lucknow- 226010
Lucknow
UTTAR PRADESH |
915224079157
krmhrclko@gmail.com |
| Dr Sushma Gaikwad |
Lifepoint Multispeciality Hospital |
145/1, Mumbai Bengaluru Highway, Near Hotel Sayaji, Wakad- 411057
Pune
MAHARASHTRA |
09423341220
gaikwad.sushma111@gmail.com |
| Dr Sandeep kumar Gupta |
MV Hospital and Research Center |
314/30, Mirza Mandi, Chowk, Lucknow-226003
Lucknow
UTTAR PRADESH |
91-5222258215
sandeepkumar.gupta@rediffmail.com |
| Dr GyanPrakash Rai |
Om Surgical and Maternity Home |
SA17/3, P-4, Shree Krishna Nagar, Paharia, Gazipur Road, Varanasi-221007
Varanasi
UTTAR PRADESH |
915422586191
omresearchcenter@gmail.com |
| Dr Vivek Saraswat |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
Department of Gastroenterology, Raibareli Road, Lucknow- 226014
Lucknow
UTTAR PRADESH |
09415004007
profviveksaraswat@gmail.com |
| Dr Mukeshkumar Jain |
Sawai Mansigh Hospital |
Department of Gastroenterology, JLN Marg, Near Maharani College, Jaipur- 302004
Jaipur
RAJASTHAN |
09414323607
drmukesh1773@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Artemis Health Sciences Institutional Ethics Committee |
Submittted/Under Review |
| Dayanand Medical College Drug Trial Ethic Committee |
Submittted/Under Review |
| Ethics Committee Om Surgical Center and Maternity Home |
Submittted/Under Review |
| Institutional Ethics Committee, KLE University |
Submittted/Under Review |
| KGMU Institutional Ethics Committee |
Submittted/Under Review |
| KRM Hospital and Research Center Ethics Committee |
Submittted/Under Review |
| LPR Ethics Committee, Lifepoint Multispeciality Hospital Pvt Ltd |
Submittted/Under Review |
| MV Hospital and Research Center Institutional Ethics Comittee |
Approved |
| SGPGI Institutional Ethics Committee |
Submittted/Under Review |
| SMS Hospital Ethics Committee |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
chronic hepatitis C (CHC) virus
infection, (1) ICD-10 Condition: K739||Chronic hepatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Sofosbuvir 400 mg tablet |
once daily as a component
of a combination antiviral treatment regimen for 12/24 Weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. A written, signed and dated Data Sharing Informed Consent
from all patients/LAR
2. Either gender with age 18 years and above
3. Patients having confirmed diagnosis of chronic hepatitis C virus
infection who are either treatment naïve or with prior treatment
experience. |
|
| ExclusionCriteria |
| Details |
1. Known hypersensitivity to Sofosbuvir or ribavirin or peginterferon
alfa, daclatasvir or any of its components
2. Contraindications to Sofosbuvir or any of the components of
the combination regimen
3. Women who are pregnant or may become pregnant and men
whose female partners are pregnant
4. Women of child bearing potential who are unwilling to use
adequate contraceptive measures unless abstinence is
considered adequate in the opinion of the investigator.
5. Any other condition as per the discretion of investigator |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Percentage of patients achieving sustained virological
response i.e. Maintenance of undetectable HCV RNA levels
at the end of 12 weeks after completion of treatment (SVR12)
· Percentage of patients achieving undetectable HCV RNA
levels at end of 4 weeks of treatment –rapid virological
response (RVR) |
Percentage of patients achieving sustained virological
response i.e. Maintenance of undetectable HCV RNA levels
at the end of 12 weeks after completion of treatment (SVR12)
· Percentage of patients achieving undetectable HCV RNA
levels at end of 4 weeks of treatment –rapid virological
response (RVR) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Percentage of patients achieving sustained virological response i.e. Maintenance of undetectable
HCV RNA levels at the end of 12 weeks after completion of treatment (SVR12)
· Percentage of patients achieving undetectable HCV RNA levels at end of 4 weeks of treatment
–rapid virological response (RVR) |
12 Weeks Post Treatment |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
18/09/2017 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The present study is a · An observational, practice based, open label, prospective, multicenter, post marketing surveillance. · The study will assess safety and efficacy of sofosbuvir, a HCV (hepatitis C virus) nucleotide analog NS5B polymerase inhibitor, as a component of a combination antiviral treatment regimen for the treatment of patients with CHC infection. · Eligible patients will be enrolled in the study and will be prescribed Sofosbuvir (manufactured by Cipla Ltd.) 400 mg tablet once daily as a component of a combination antiviral treatment regimen. · The study population consists of patients with CHC infection |