NCT02580474

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2016

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 20, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

2.2 years

First QC Date

October 16, 2015

Last Update Submit

July 17, 2018

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

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

    36 Week

Secondary Outcomes (5)

  • 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

  • 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

Study Arms (1)

Daclatasvir plus Asunaprevir

EXPERIMENTAL
Drug: Daclatasvir plus Asunaprevir

Interventions

Daclatasvir plus AsunaprevirDRUG
Daclatasvir plus Asunaprevir

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Myeong Jun Song

Daejeon, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 30400729DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

daclatasvirasunaprevir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 16, 2015

First Posted

October 20, 2015

Study Start

February 1, 2016

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

July 18, 2018

Record last verified: 2018-07

Locations

KR(1)