An observational study in Chronic Hepatitis C, sponsored by Sang Gyune Kim. Status unknown at 10 sites in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2017-03-07.
Sponsored by Sang Gyune Kim · Observational
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
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.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's planned enrollment of 103 is below the median of 250 across 687 observational studies indexed under Hepatitis A.
Browse Hepatitis A studies →Sang Gyune Kim is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Genotype 1b, advanced fibrotic/cirrhotic Korean patients with chronic hepatitis C aged over 18, without baseline NS5A RAVs (Y93 and/or L31)
Exclusion Criteria:
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.
Also known as: Daclatasvir and Asunaprevir combined treatment for 24 weeks
The change of liver fibrosis stage at 48 weeks assessed by transient elastography in patients treated with Daclatasvir and Asunaprevir
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
Time frame: baseline to 48weeks
Proportion of patients who were treated with Daclatasvir and Asunaprevir achieved SVR12 assessed by HCV RNA
Time frame: 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
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
The change of AST to Platelet Ratio Index
APRI = \[(AST/upper limit of normal)/platelet count\]x100
Time frame: baseline to 48weeks, 96weeks, 144weeks, 192weeks, 240weeks
The change of Fibrosis 4 (Fib-4) index
FIB-4 = age (years) × AST \[IU/L\] / \[platelet count × sqr(ALT \[IU/L\])\]
Time frame: 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
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
Time frame: 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
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
Time frame: baseline to 48weeks, 96weeks, 144weeks, 192weeks, 240weeks
The change of Fibrometer score
alpha2 macroglobulin, GGT, AST, ALT, prothrombin index, urea, platelet count
Time frame: baseline to 48weeks, 96weeks, 144weeks, 192weeks, 240weeks
Plan to share: No
This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Sang Gyune Kim