Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02563665
Recruitment Status : Unknown
Verified October 2016 by Institute of Liver and Biliary Sciences, India.
Recruitment status was:  Recruiting
First Posted : September 30, 2015
Last Update Posted : October 28, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
CKD With Hepatitis C

Layout table for study information
Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : September 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Group/Cohort
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



Primary Outcome Measures :
  1. Sustained Virologic Response 24 defined as HCV RNA <Lower Level of Qunatification 24 weeks after discontinuation of therapy. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. number of adverse Events in both groups [ Time Frame: 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563665


Contacts
Layout table for location contacts
Contact: Dr Suman Lata Nayak, DM 011-46300000 sumanmassu2000@yahoo.co.in

Locations
Layout table for location information
India
Institute of liver and Biliary Sciences Recruiting
New Dlehi, Delahi, India, 110070
Contact: Dr Suman Lata Nayak, DM    01146300000    sumanmassu2000@yahoo.co.in   
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
Investigators
Layout table for investigator information
Principal Investigator: Dr Suman Lata Nayak, DM Institute of Liver and Biliary Sciences

Layout table for additonal information
Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT02563665     History of Changes
Other Study ID Numbers: ILBS-HCKD/001/SOFO/2015
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis
Hepatitis A
Hepatitis C
Kidney Diseases
Renal Insufficiency, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Urologic Diseases
Renal Insufficiency
Antiviral Agents
Sofosbuvir
Anti-Infective Agents