An observational study to understand usage and effect of combination of ledipasvir and sofosbuvir in adult patients with Hepatitis C Infectio

Not Applicable

• Conditions: Health Condition 1: null- Chronic Hepatitis C

• Registration Number: CTRI/2016/11/007468
• Lead Sponsor: Torrent Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-02-18
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 88

Inclusion Criteria

1.Patient willing to provide informed consent

2.Female or male patient aged 18 years or above

3.Patients chronically infected with hepatitis C virus (HCV) genotype 1

4.Patient found positive for HCV RNA test

5.Screening laboratory values within clinically acceptable range

6.Treatment naïve and experienced patients with or without cirrhosis(compensated as well as decompensated)

7.Patients who are started on ledipasvir plus sofosbuvir combination treatment in normal clinical practice setting

8.Patients must provide written consent form to use personal and/or health data prior to the entry into the study

Exclusion Criteria

1.HCV Genotypes other than genotype-1 infection; mixed genotype infections

2.Pregnant or nursing female or male with pregnant female partner

3.Female or male with female partner planning to become pregnant while enrolled in this study

4.Co-infection with HIV or hepatitis B virus (HBV)

5.Patients of hepatocellular carcinoma

6.History of clinically significant illness or any other major medical disorder that may interfere with treatment, assessment or compliance with the protocol

7.Any contraindication for the administration of direct acting antivirals Ledipasvir and sofosbuvir

8.Patients participating in other clinical trials

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To assess proportion of participants with Sustained Virological Response(SVR)Timepoint: After 12 weeks post treatment

Secondary Outcome Measures

Name	Time	Method
1.To understand the effect of Ledipasvir plus sofosbuvir either alone or in combination with ribavirin in HCV Genotype 1 <br/ ><br>2.To understand the effect of Ledipasvir plus sofosbuvir in Treatment naïve or Treatment experienced patients with or without cirrhosis <br/ ><br>3.To assess the adverse events during the study period <br/ ><br>Timepoint: After 12 weeks post treatment