Safety and Efficacy of Sofosbuvir Based Antiviral Regimen for Treating Hepatitis C in Patients With Moderate to Advanced Chronic Kidney Disease and Patients Receiving Renal Replacement Therapy

Withdrawn

• Conditions: CKD With Hepatitis C

• Registration Number: NCT02563665
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Brief Summary

All patients with chronic kidney disease (stages 3, 4 and 5) and chronic dialysis patients with HCV infection attending nephrology and Hepatology OPD or getting outpatient dialysis at the dialysis unit of ILBS.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-26
• Study First Submitted QC: 2015-09-28
• Study First Posted: 2015-09-30
• Status Verified: 2016-10
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Last Update Submitted: 2019-11-01
• Last Update Posted: 2019-11-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients with moderate to severe renal dysfunction (CKD stage 3, 4, 5) and chronic dialysis patients
2. Patients consented for the study protocol by signing the informed consent.

Exclusion Criteria

1. Age less than 18 years
2. Confirmed pregnancy
3. HCV-HIV Co infection
4. HBV-HCV co infection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sustained Virologic Response 24 defined as HCV RNA <Lower Level of Qunatification 24 weeks after discontinuation of therapy.	1 year

Secondary Outcome Measures

Name	Time	Method
number of adverse Events in both groups	2 years

Trial Locations

Locations (1)

Institute of liver and Biliary Sciences; 🇮🇳 New Delhi, Delhi, India