CTRI/2019/12/022216 [Registered on: 02/12/2019] Trial Registered Prospectively
Last Modified On:
09/12/2020
Post Graduate Thesis
No
Type of Trial
PMS
Type of Study
Drug
Study Design
Other
Public Title of Study
A study to see the safety of Fixed Dose Combination (FDC) of Sofosbuvir/Daclatasvir
Scientific Title of Study
Multicenter, Open Label, Prospective Phase IV Study to Evaluate the Safety and Efficacy of Fixed Dose Combination (FDC) of Sofosbuvir/Daclatasvir in Adults with Genotype 3 Chronic Hepatitis C Virus Infection in India
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
MYL-MHD-4001 Version 3.0, Dated 28 May 2019
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Postgraduate Institute of Medical Education and Research
Postgraduate Institute of Medical Education and Research, Chandigarh Chandigarh CHANDIGARH
9855319529
djsamanta@yahoo.co.in
Dr Sheetal Amit Mahajani
Sahyadri Super Speciality Hospital
Plot No:30 C, Erandawane, Karve Road, Pune 411004,
Maharashtra, India
Pune MAHARASHTRA
9822912080
drsheetalmahajani@gmail.com
Dr Praveen Sharma
Sir Gangaram Hospital
Sir Gangaram Hospital Marg, Rajinder Nagar, New Delhi New Delhi DELHI
9810365151
drpraveen_sharma@yahoo.com
Dr Kabrawala Mayank Vasantlal
Surat Institute of Digestive Sciences
A Unit of SIDS Health care Pvt Ltd., Vijay Nagar Gate No-3, Besides Nirman Bhavan, Opp. Gandhi College, Majura Gate ,Ring Road,Surat-395002 Surat GUJARAT
1. Willing and able to provide written informed consent
2. Male or female, age equal to or greater than 18 to equal to or less than 65 years
3. Confirmed chronic HCV genotype 3 infection
4. Eligible to receive sofosbuvir/ daclatasvir fixed dose combination in HCV genotype 3
ExclusionCriteria
Details
1. Pregnant or nursing female or male with pregnant female partner not willing to use adequate physical barrier.
2. Chronic liver disease of a non-HCV etiology
3. Known coinfection with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV)
4. Documented or suspected Hepatocellular Carcinoma (HCC)
5. Evidence of liver cirrhosis
6. Patients with adequate hemoglobin levels
7. Patients with impaired renal function
8. Patients on Medicinal products which are contraindicated to be used with sofosbuvir/ daclatasvir based combination therapy
9. History of significant pulmonary disease, significant cardiac disease or porphyria.
Method of Generating Random Sequence
Method of Concealment
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Incidence of adverse events
Treatment period and up to 4 weeks after EOT
Secondary Outcome
Outcome
TimePoints
1. Percentage of subjects having the Sustained Virological Response i.e. virological response measured at SVR12 Visit
12 weeks after the End of Treatment
Target Sample Size
Total Sample Size="250" Sample Size from India="250" 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 4
Date of First Enrollment (India)
04/12/2019
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="0" Months="6" Days="9"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
Not yet done
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This is a phase-IV multicenter, prospective, open label single arm study designed to determine the safety & efficacy of Sofosbuvir/Daclatasvir fixed dose combination in adult Indian patients with confirmed chronic HCV genotype 3 infection.
The Primary objective of the study - To assess the safety and tolerabilitThis is a phase-IV multicenter, prospective, open label single arm study designed to determine the safety & efficacy of Sofosbuvir/Daclatasvir fixed dose combination in adult Indian patients with confirmed chronic HCV genotype 3 infection. The Primary objective of the study - To assess the safety and tolerability of Sofosbuvir/Daclatasvir FDC in adults with Chronic HCV genotype 3 infection.
The Secondary objective of the study - To determine the efficacy of fixed dose combination (FDC) of Sofosbuvir/Daclatasvir in adults with Chronic HCV Genotype 3 infection, as measured by the sustained virologic response rates at 12 weeks (SVR12) after End of Treatmenty of Sofosbuvir/Daclatasvir FDC in adults with Chronic HCV genotype 3 infection.