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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02563665 |
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Date of registration:
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26/09/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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September 2015 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT02563665 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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India
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Contacts
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Name:
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Dr Suman Lata Nayak, DM |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institute of Liver and Biliary Sciences |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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CKD With Hepatitis C
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Primary Outcome(s)
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Sustained Virologic Response 24 defined as HCV RNA
[Time Frame: 1 year]
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Secondary Outcome(s)
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number of adverse Events in both groups
[Time Frame: 2 years]
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Secondary ID(s)
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ILBS-HCKD/001/SOFO/2015
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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