An observational study to understand usage and effect of daclatasvir use with sofosbuvir for the treatment of adults with chronic hepatitis C infections

Not Applicable

• Conditions: Health Condition 1: null- Chronic HCV

• Registration Number: CTRI/2017/07/009056
• Lead Sponsor: Torrent Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-09-11
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 54

Inclusion Criteria

1.Patient willing to provide informed consent

2.Female or male patient aged 18 years or above

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

4.Patient found positive for HCV RNA test

5.Screening laboratory values within clinically acceptable range

6.Treatment naïve and experienced patients without cirrhosis

7.Patients who are started on daclatasvir 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-3 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 with evidence of cirrhosis or 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 daclatasvir and sofosbuvir

Study & Design

• Study Type: Observational
• Study Design: Not specified