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WithdrawnNCT02563665Updated Nov 5, 2019

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

An observational study in CKD With Hepatitis C, sponsored by Institute of Liver and Biliary Sciences, India. Withdrawn at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-05.

Sponsored by Institute of Liver and Biliary Sciences, India · Observational

Why this study was withdrawn
Lack of funds
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • CKD With Hepatitis C
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

Browse Hepatitis A studies →

Lead sponsor

Institute of Liver and Biliary Sciences, India is the lead sponsor of 296 studies on the registry; 84 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients with chronic kidney disease (stages 3, 4 and 5) and chronic dialysis patients with Hepatitis C infection attending nephrology and Hepatology OPD (Out Patient Department) or getting outpatient dialysis at the dialysis unit of Institute of Liver and Biliary Sciences.

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

Exclusion Criteria:

  1. Age less than 18 years
  2. Confirmed pregnancy
  3. HCV-HIV Co infection
  4. HBV-HCV co infection
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • advanced chronic kidney disease

    Subjects on dialysis with GFR (Glomerular Filtration Rate) \> 30

  • Renal replacement therapy.

    Subjects who are not on dialysis with GFR (Glomerular Filtration Rate) \< 15

06

What researchers measure

Primary outcomes

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

    Time frame: 1 year

Secondary outcomes

  1. number of adverse Events in both groups

    Time frame: 2 years

07

Study locations

1 site
  • Institute of liver and Biliary Sciences
    New Delhi, Delhi 110070, India
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02563665
Lead sponsor
Institute of Liver and Biliary Sciences, India
Responsible party
Sponsor
First posted
Sep 30, 2015
Start date
Sep 2015
Primary completion
Sep 2017 (estimated)
Completion
Sep 2017 (estimated)
Last update
Nov 5, 2019

Study contacts

Dr Suman Lata Nayak, DM
principal investigator · Institute of Liver and Biliary Sciences

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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