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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2018-04-30

Brief Summary

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

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Detailed Description

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Conditions

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Hepatitis C

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Daclatasvir plus Asunaprevir

Group Type EXPERIMENTAL

Daclatasvir plus Asunaprevir

Intervention Type DRUG

Interventions

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Daclatasvir plus Asunaprevir

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No