To Study the Efficacy of Directly Acting Antivirals In Patients of Hepatitis C Infection who are On Dialysis.

Completed

• Conditions: End stage renal disease,

• Registration Number: CTRI/2018/06/014408
• Lead Sponsor: INDRAPRASTHA APOLLO HOSPITAL

Brief Summary

This study will be a single center, prospective, observational study of “Efficacy and safety of

directly acting antivirals in Chronic kidney disease patients on maintenance hemodialysis

with Chronic hepatitis C virus infection.†It will be conducted at Indraprastha Apollo hospital,

New Delhi for a period of 2 years between June 2017 and May 2019. Only patients with

chronic renal disease stage V who are on hemodialysis and having Chronic hepatitis C with

or without compensated cirrhosis will be taken. These patients then will be evaluated and

will be treated for chronic hepatitis C infection with the new directly acting antivirals (DAAs).



Patients will be followed up during the treatment period (12 weeks) and up to 12 weeks

post-treatment. Overall efficacy of directly acting antivirals in achieving the virological

response at end of the treatment and sustained virological response at 12 weeks post-treatment

will be assessed. Patients will also be interviewed and evaluated for adverse

effects of DAAs.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-28
• Study Completion: 2018-11-30
• Last Update Posted: 2019-10-13

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Patients with Chronic Kidney Disease on Hemodialysis with concomitant Hepatitis C infection with or without compensated Liver Cirrhosis.

Exclusion Criteria

Patients with Decompensated Liver Cirrhosis 2) Patients with Significant alcohol intake history 3) Concomitant Chronic Hepatitis B infection or HIV infection 4) NASH 5) Pregnancy.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
weeks post therapy	12 weeks post therapy
Percentage of patients achieving the Sustained Virological response at 12	12 weeks post therapy

Secondary Outcome Measures

Name	Time	Method
a) To find out percentage of patients achieving the Virological response at end of	therapy

Trial Locations

Locations (1)

INDRAPRASTHA APOLLO HOSPITAL; 🇮🇳 Delhi, DELHI, India

INDRAPRASTHA APOLLO HOSPITAL

🇮🇳Delhi, DELHI, India

K N SINGH

Principal investigator

9811471820

drknsinghnephro@gmail.com