An Observational Post Marketing study to check the Safety and Effectiveness of Sofosbuvir based treatment in Patients with Chronic Hepatitis C

Not Applicable

Recruiting

• Conditions: Chronic hepatitis, unspecified,

• Registration Number: CTRI/2017/08/009547
• Lead Sponsor: Cipla Ltd

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-18
• Last Update Posted: 2018-11-17

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Any other condition as per the discretion of investigator.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients achieving sustained virological	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)
response i.e. Maintenance of undetectable HCV RNA levels	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)
at the end of 12 weeks after completion of treatment (SVR12)	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 undetectable HCV RNA	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)
levels at end of 4 weeks of treatment –rapid virological	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)
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 Measures

Name	Time	Method
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)

Trial Locations

Locations (10)

Artemis Hospital; 🇮🇳 Gurgaon, HARYANA, India

Dayanand Medical College and Hospital; 🇮🇳 Ludhiana, PUNJAB, India

King George Medical University Gandhi Memorial and Associated Hospital; 🇮🇳 Lucknow, UTTAR PRADESH, India

KLES Dr Prabhakar Kore Hospital and MRC; 🇮🇳 Belgaum, KARNATAKA, India

KRM Hospital and Research Center; 🇮🇳 Lucknow, UTTAR PRADESH, India

Lifepoint Multispeciality Hospital; 🇮🇳 Pune, MAHARASHTRA, India

MV Hospital and Research Center; 🇮🇳 Lucknow, UTTAR PRADESH, India

Om Surgical and Maternity Home; 🇮🇳 Varanasi, UTTAR PRADESH, India

Sanjay Gandhi Post Graduate Institute of Medical Sciences; 🇮🇳 Lucknow, UTTAR PRADESH, India

Sawai Mansigh Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Artemis Hospital

🇮🇳Gurgaon, HARYANA, India

Dr Kaushal Madan

Principal investigator

09958787720

k_madan_2000@yahoo.com