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

Phase 4

Completed

• Conditions: Hepatitis C
• Interventions: Drug: Daclatasvir plus Asunaprevir

• Registration Number: NCT02580474
• Lead Sponsor: Myeong Jun Song

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-16
• Study First Submitted QC: 2015-10-16
• Study First Posted: 2015-10-20
• Study Start: 2016-02
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-17
• Last Update Posted: 2018-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Daclatasvir plus Asunaprevir	Daclatasvir plus Asunaprevir	-

Primary Outcome Measures

Name	Time	Method
the proportion of subjects with plasma HCV RNA levels below 15 IU/mL at Week 12 After End of Treatment	36 Week

Secondary Outcome Measures

Name	Time	Method
Percentage of subjects with ALT normalization at each visit from the baseline	4, 12, 24, 36 week
To evaluate the percentage of subjects with Sustained Virologic Response at Week 12 After End of Treatment	36 Week
Change in HCV RNA at each visit from the baseline	4, 12, 24, 36 week
Percentage of subjects who experience viral breakthrough at each visit from the baseline	4, 12, 24, 36 week
Percentage of subjects who shows Tolerability of Daclatasvir and Asunaprevir at each visit from	4, 12, 24, 36 week

Trial Locations

Locations (1)

Myeong Jun Song; 🇰🇷 Daejeon, Korea, Republic of