Regression of Liver Fibrosis After Daclatasvir and Asunaprevir Treatment (RELIF-C)

March 4, 2017 updated by: Sang Gyune Kim

Regression of Liver Fibrosis Assessed by Transient Elastography After Daclatasvir and Asunaprevir Combined Treatment in Advanced Fibrotic/Cirrhotic Patients With Chronic Hepatitis C Genotype 1b Infection

A study on regression of liver fibrosis assessed by transient elastography after Daclatasvir and Asunaprevir combined treatment in advanced fibrotic/cirrhotic patients with chronic hepatitis C genotype 1b Infection

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The measurement of liver stiffness by transient elastography (TE) has been shown to correlate with the hepatic fibrosis stage and to have considerable accuracy for the diagnosis of cirrhosis in patients with chronic hepatitis C. Previous studied reported that liver stiffness is significantly reduced in SVR patients with pegylated interferon (IFN) and ribavirin treatment. Once a patient achieve sustained virological response (SVR), and resultingly lower liver stiffness score than baseline value, it is believed that he will have a better long-term outcome due to the improvement of liver fibrosis.

Daclatasvir(DCV) and Asunaprevir(ASV) combined treatment showed a greater SVR rate in CHC compared to IFN based therapy. The investigators hypothesize that DCV and ASV combined treatment may achieve the improvement of liver stiffness measured by TE and a more favorable clinical outcomes in patients with advanced liver fibrosis. The investigators will also compare the change of fibrosis stage assessed by TE between this study subjects and those treated with other DAA agents during same observational period.

Study Type

Observational

Enrollment (Anticipated)

103

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Incheon, Korea, Republic of, 21565
        • Gachon University Gil Medical Center
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital
      • Seoul, Korea, Republic of, 07985
        • Ewha Womans University Mokdong Hospital
      • Seoul, Korea, Republic of, 04763
        • Hanyang University Hospital
      • Seoul, Korea, Republic of, 04401
        • Soonchunhyang University Hospital
      • Wonju, Korea, Republic of, 26426
        • Wonju Severance Christian Hospital
    • Chungcheongnam-do
      • Cheonan, Chungcheongnam-do, Korea, Republic of, 31151
        • Soonchunhyang University Cheonan Hospital
    • Gyeonggi do
      • Bucheon, Gyeonggi do, Korea, Republic of, 14584
        • Soon Chun Hyang University Bucheon Hospital
    • Gyeonggi-do
      • Ansan, Gyeonggi-do, Korea, Republic of, 15355
        • Korea University Ansan Hospital
    • Incheon
      • Jung-gu, Incheon, Korea, Republic of, 22332
        • Inha University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Genotype 1b, advanced fibrotic/cirrhotic Korean patients with chronic hepatitis C aged over 18, without baseline NS5A RAVs (Y93 and/or L31)

Description

Inclusion Criteria:

  • Chronically infected with Hepatitis C virus genotype 1b
  • HCV RNA ≥ 10^4 IU/mL (10,000 IU/mL)
  • Chronic Hepatitis C with advanced fibrosis or cirrhosis (defined as ≥F3, ≥8 kilopascals)
  • Treatment-naïve or those who previously failed to treatment with peg-interferon alfa and ribavirin
  • Women of childbearing potential (WOCBP) and men, who use effective methods of birth control

Exclusion Criteria:

  • Patients with baseline key NS5A RAVs (Y93 and/or L31)
  • Estimated GFR < 30mL/min without hemodialysis
  • Alanine aminotransferase (ALT) > 100 IU/L
  • Coinfection with other hepatitis virus or human immunodeficiency virus
  • A daily alcohol intake >30 g
  • Decompensated liver disease or hepatocellular carcinoma, liver or any other organ transplantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Daclatasvir plus Asunaprevir treatment
Among patients taking Daclatasvir and Asunaprevir combined treatment and having advanced liver fibrosis assessed by transient elastography
Drug: Daclatasvir and Asunaprevir
Daclatasvir and Asunaprevir combined treatment will not be assigned to the enrolled patients, but the patients who are treated with Daclatasvir and Asunaprevir will be included in this observational study.
Other Names:
  • Daclatasvir and Asunaprevir combined treatment for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of liver fibrosis stage at 48 weeks assessed by transient elastography in patients treated with Daclatasvir and Asunaprevir
Time Frame: baseline to 48weeks
To compare the change of liver fibrosis stage (defined as F3, ≥8; F4, ≥12) assessed by transient elastography between baseline and 48 weeks in advanced fibrotic/cirrhotic Chronic Hepatitis C patients who achieved sustained virological response with Daclatasvir and Asunaprevir combined treatment
baseline to 48weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients who were treated with Daclatasvir and Asunaprevir achieved SVR12 assessed by HCV RNA
Time Frame: baseline to 36 weeks
baseline to 36 weeks
Proportion of patients who maintained sustained virologic response at SVR24, SVR72, SVR120, SVR168, and SVR216.
Time Frame: baseline to 48weeks, 96weeks, 144weeks, 192weeks, 240weeks
baseline to 48weeks, 96weeks, 144weeks, 192weeks, 240weeks
The change of liver fibrosis stage assessed by transient elastography at 96weeks, 144weeks, 192weeks, 240weeks in patients treated with Daclatasvir and Asunaprevir
Time Frame: baseline to 96weeks, 144weeks, 192weeks, 240weeks
baseline to 96weeks, 144weeks, 192weeks, 240weeks
The change of AST to Platelet Ratio Index
Time Frame: baseline to 48weeks, 96weeks, 144weeks, 192weeks, 240weeks
APRI = [(AST/upper limit of normal)/platelet count]x100
baseline to 48weeks, 96weeks, 144weeks, 192weeks, 240weeks
The change of Fibrosis 4 (Fib-4) index
Time Frame: baseline to 48weeks, 96weeks, 144weeks, 192weeks, 240weeks
FIB-4 = age (years) × AST [IU/L] / [platelet count × sqr(ALT [IU/L])]
baseline to 48weeks, 96weeks, 144weeks, 192weeks, 240weeks
Comparison of change of liver fibrosis stage assessed by transient elastography between Daclatasvir and Asunaprevir combined treatment versus other DAA treatment
Time Frame: baseline to 48weeks, 96weeks, 144weeks, 192weeks, 240weeks
Comparison of change of liver fibrosis stage assessed by transient elastography at 48weeks, 96weeks, 144weeks, 192weeks, 240weeks between Daclatasvir and Asunaprevir combined treatment versus other DAA treatment during same observational period
baseline to 48weeks, 96weeks, 144weeks, 192weeks, 240weeks
Comparison of the incidence of hepatocellular carcinoma or liver cirrhosis complications between Daclatasvir and Asunaprevir combined treatment versus other DAA treatment
Time Frame: baseline to 48weeks, 96weeks, 144weeks, 192weeks, 240weeks
Compare the incidence of hepatocellular carcinoma or liver cirrhosis complications at 48weeks, 96weeks, 144weeks, 192weeks, 240weeks between Daclatasvir and Asunaprevir combined treatment versus other Direct antiviral agents during same observational period
baseline to 48weeks, 96weeks, 144weeks, 192weeks, 240weeks
The change of Fibrometer score
Time Frame: baseline to 48weeks, 96weeks, 144weeks, 192weeks, 240weeks
alpha2 macroglobulin, GGT, AST, ALT, prothrombin index, urea, platelet count
baseline to 48weeks, 96weeks, 144weeks, 192weeks, 240weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sang Gyune Kim

Collaborators

Bristol-Myers Squibb
Korea University
Gachon University Gil Medical Center
Seoul National University Boramae Hospital
Severance Hospital
Ewha Womans University Mokdong Hospital
Hanyang University Seoul Hospital
Inha University Hospital

Investigators

  • Principal Investigator: Sang Gyune Kim, Professor, Soonchunhyang University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

August 3, 2016

First Submitted That Met QC Criteria

August 9, 2016

First Posted (Estimate)

August 12, 2016

Study Record Updates

Last Update Posted (Actual)

March 7, 2017

Last Update Submitted That Met QC Criteria

March 4, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI444-392

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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