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

A Prospective Study on 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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02563665

Enrollment

Registered

2015-09-30

Start date

2015-09-30

Completion date

2017-09-30

Last updated

2019-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CKD With Hepatitis C

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
number of adverse Events in both groups	2 years

Countries

India

Outcome results