The Safety and Efficacy of Daclatasvir and Asunaprevir Wi... | NCT02580474

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

NCT02580474

Sponsor

Myeong Jun Song

Status

Completed

Last Update Posted

Jul 18, 2018Actual

Enrollment

21Actual

Phase

Phase 4

Conditions

Hepatitis C

Interventions

Daclatasvir plus Asunaprevir

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2016Actual

Primary Completion Date

Apr 2018Actual

Completion Date

Apr 2018Actual

First Submitted Date

Oct 16, 2015

First Submission Date that Met QC Criteria

Oct 16, 2015

First Posted Date

Oct 20, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 17, 2018

Last Update Posted Date

Jul 18, 2018Actual

Name	Class
Bristol-Myers Squibb	INDUSTRY
Soonchunhyang University Hospital	OTHER
Dankook University	OTHER
Chungnam National University Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Label	Type	Description	Intervention Names
Daclatasvir plus Asunaprevir	Experimental		Drug: Daclatasvir plus Asunaprevir

Name	Type	Description	Arm Group Labels	Other Names
Daclatasvir plus Asunaprevir	Drug		Daclatasvir plus Asunaprevir

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
To evaluate the percentage of subjects with Sustained Virologic Response at Week 12 After End of Treatment		36 Week
Percentage of subjects with ALT normalization at each visit from the baseline		4, 12, 24, 36 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30400729	Derived	Lee BS, Song MJ, Kwon JH, Lee TH, Jang JW, Kim SH, Lee SH, Kim HS, Kim JH, Kim SB, Ko SY, Song DS. Efficacy and Safety of Daclatasvir and Asunaprevir in Patients with Hepatitis C Virus Genotype 1b Infection on Hemodialysis. Gut Liver. 2019 Mar 15;13(2):191-196. doi: 10.5009/gnl18240.

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human

ID	Term
C549273	daclatasvir
C571889	asunaprevir