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The Safety and Efficacy of Daclatasvir and Asunaprevir With Chronic HCV Genotype 1b Infection and Chronic Renal Failure | Clinical Trials | Clareo Health

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The Safety and Efficacy of Daclatasvir and Asunaprevir With Chronic HCV Genotype 1b Infection and Chronic Renal Failure

NCT02580474•Myeong Jun Song

View on ClinicalTrials.gov

Summary

Safety and Efficacy of DAAs (Daclatasvir+Asunaprevir) in patients with chronic hepatitis C and chronic renal failure will be assessed.

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•HCV RNA Positive and Genotype 1b
•No history or signs or symptoms of decompensated liver disease or hepatocellular carcinoma within 6 months
•A patient who is on dialysis, or if not MDRD eGFR\<30ml/min
•HCV treatment history: HCV treatment-naive participants, defined as never having received HCV treatment with any approved or investigational drug (including vaccines); OR HCV treatment-experienced, defined as having received previous HCV treatment with any (pegylated) interferon (\[Peg\]IFN)-based drug regimen (with or without ribavirin \[RBV\] and not including a direct-acting antiviral agent \[DAA\]). Last dose in this previous HCV treatment course should have occurred at least 2 months prior to screening
•No baseline mutation NS5A polymorphism including L31F/I/M/V and Y93H

Exclusion Criteria

•A patient who having received Daclatasvir or Asunaprevir
•Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study
•Evidence of a medical condition contributing to chronic liver disease other than HCV or seropositive for HIV
•Diagnosed or suspected hepatocellular carcinoma or other malignancies
•Any history of, or current evidence of, clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage)
•Received solid organ or bone marrow transplant
•Current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance
•Significant renal, cardiovascular, pulmonary, or neurological disease and uncontrolled diabetes or hypertension in the opinion of the investigator
•Known hypersensitivity to study drugs, metabolites, or formulation excipients
•Who has taken investigational drugs within 2 months.

Locations (1)

Myeong Jun Song

Daejeon, South Korea

Key Dates

Start Date

February 1, 2016

Primary Completion Date

April 1, 2018

Completion Date

April 1, 2018

Last Updated

July 18, 2018

Enrollment

ACTUAL participants

Conditions

Hepatitis C

Interventions

Daclatasvir plus Asunaprevir

DRUG

Implementing Low-Barrier HCV Treatment in a Jail Setting

NCT06953479

HEPATITIS C (HCV)Incarceration+2 more

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RECRUITINGNA

Project I Test: Implementing HIV Testing in Opioid Treatment Programs

NCT03135886

HIV/AIDSHepatitis C+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 18, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Safety and Efficacy of Daclatasvir and Asunaprevir With Chronic HCV Genotype 1b Infection and Chronic Renal Failure

Inclusion Criteria

Exclusion Criteria

Implementing Low-Barrier HCV Treatment in a Jail Setting

Project I Test: Implementing HIV Testing in Opioid Treatment Programs

Persuasive Health Communication Intervention for HIV/HCV

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Acceptability of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users in Non-conventional Structures