Micro RNA-122 and the Clinical Course of Patients With Chronic Hepatitis C
The Predictive Role of Serum Micro RNA-122 to the Clinical Course of Chronic Hepatitis C Patients
1 other identifier
observational
200
1 country
5
Brief Summary
Combination therapy with peginterferon plus ribavirin has become the current standard of care for chronic hepatitis C (CHC) patients, with an overall sustained virologic response (SVR) rate of 54-63%. Based on the ample evidence, a 48-week course of peginterferon plus weight-based ribavirin therapy is widely recommended to treat HCV genotype 1 infection in different parts of the world. Despite the increased SVR rates with the improved medical therapies, about 25-50% and 10-20% of HCV genotype 1 and HCV genotype 2/3 patients may experience relapse after the cessation of therapy with undetectable HCV viremia at the end of treatment. Moreover, combination therapy is costly and may cause various adverse events. Therefore, individualized therapy based on outcome analysis should be adopted to save medical cost as well as to lessen inadequate treatment. Few studies are aimed to evaluate the host responses of micro RNA regulation during interferon-based therapy and its relationships to the overall treatment responses. Micro RNA (miRNA) is a single-stand RNA composed of 21-23 nucleotides, which may regulate the function of messenger RNA (mRNA). The regulating mechanisms involving micro RNA between the hosts and the HCV virus include (1) auto-regulation of HCV mRNA by HCV miRNA; (2) regulation of host mRNA by HCV miRNA; and (3) regulation of HCV mRNA by host miRNA. MiR-122 is the abundant liver-specific miRNA which is crucial for efficient HCV replication in culture Huh7 cells stably expressing HCV replicons. Recently, an in vivo study for hepatic miR-122 of 42 patients with CHC who received IFN-based therapy showed that patients who did not respond to IFN therapy had markedly decreased pretreatment miR-122 levels. Although miR-122 is abundant in the liver, liver biopsy is still considered an invasive procedure, which prevents its widespread use in routine clinical practice. The miRNA can be detected in the sera and is stable after 24 hours of room temperature store or repeated freezing and de-freezing. The serum miR-122 levels can reflect the severity of liver injuries in a rat acetaminophen toxicity model. Because miR-122 is liver specific and the miRNA is stable in the sera, the investigators aimed to evaluate the role of serum and hepatic miR-122 on the viral kinetics and the treatment responses and in HCV patients receiving peginterferon and ribavirin combination therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2009
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 16, 2009
CompletedFirst Posted
Study publicly available on registry
September 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedMarch 26, 2010
March 1, 2010
1 year
September 16, 2009
March 25, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serum micro RNA-122 and sustained virologic response (SVR)
18 months
Study Arms (2)
Peg-IFN + RBV with SVR
HCV patients receiving peginterferon alfa-2a and ribavirin with sustained virologic response
Peg-IFN + RBV without SVR
HCV patients receiving peginterferon alfa-2a and ribavirin without sustained virologic response
Eligibility Criteria
Patients with chronic hepatitis C receving combination therapy with peginterferon alfa-2a and ribavirin
You may qualify if:
- Treatment naïve
- Age 18 and older than 18 years old
- Anti-HCV (Abbott HCV EIA 2.0, Abbott Diagnostic, Chicago, IL) positive \> 6 months
- Detectable serum quantitative HCV-RNA (Cobas Taqman v2.0, Roche Diagnostics)
- Serum alanine aminotransferase levels above the upper limit of normal with 6 months of enrollment
- A liver biopsy consistent with the diagnosis of chronic hepatitis C
- Receive 24 or 48 weeks of PEG-IFN alfa plus ribavirin (1,000 mg/day for BW \< 75 kg; 1,200 mg/day for BW ≥ 75 kg for HCV genotype 1; 800 mg/day for HCV genotype 2)
You may not qualify if:
- Anemia (hemoglobin \< 13 gram per deciliter for men and \< 12 gram per deciliter for women)
- Neutropenia (neutrophil count \<1,500 per cubic milliliter)
- Thrombocytopenia (platelet \<90,000 per cubic milliliter)
- Co-infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- Mixed HCV genotype 1 with other genotype infection
- Chronic alcohol abuse (daily consumption \> 20 gram per day)
- Decompensated liver disease (Child-Pugh class B or C)
- Serum creatinine level more than 1.5 times the upper limit of normal
- Autoimmune liver disease
- Neoplastic disease
- An organ transplant
- Immunosuppressive therapy
- Poorly controlled autoimmune diseases, pulmonary diseases, cardiac diseases, psychiatric diseases, neurological diseases, diabetes mellitus
- Evidence of drug abuse
- Unwilling to have contraception
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
National Taiwan University Hospital, Yun-Lin Branch
Douliu, Taiwan
Kinmen Hospital
Kimmen, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Far Eastern Memorial Hospital
Taipei, Taiwan
Taipei Municipal Hospital, Ren-Ai Branch
Taipei, Taiwan
Biospecimen
Serum and hepatic micro RNA-122
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Chen-Hua Liu, MD
National Taiwan University Hospital
- STUDY DIRECTOR
Jia-Horng Kao, MD, PhD
National Taiwan University Hospital
- PRINCIPAL INVESTIGATOR
Tung-Hung Su, MD
Kimmen Hospital
- PRINCIPAL INVESTIGATOR
Cheng-Chao Liang, MD, BS
Far Estern Menorial Hospital
- PRINCIPAL INVESTIGATOR
Chih-Lin Lin, MD, BS
Taipei Municipal Hospital, Ren-Ai Branch
- PRINCIPAL INVESTIGATOR
Shih-Jer Hsu, MD
National Taiwan University Hospital, Yun-Lin Branch
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 16, 2009
First Posted
September 18, 2009
Study Start
September 1, 2009
Primary Completion
September 1, 2010
Study Completion
December 1, 2010
Last Updated
March 26, 2010
Record last verified: 2010-03