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Micro RNA-122 and the Clinical Course of Patients With Chronic Hepatitis C

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ClinicalTrials.gov Identifier: NCT00980161
Recruitment Status : Unknown
Verified March 2010 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : September 18, 2009
Last Update Posted : March 26, 2010
Information provided by:

Study Description
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.

Condition or disease
Hepatitis C

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: The Predictive Role of Serum Micro RNA-122 to the Clinical Course of Chronic Hepatitis C Patients
Study Start Date : September 2009
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :
  1. Serum micro RNA-122 and sustained virologic response (SVR) [ Time Frame: 18 months ]

Biospecimen Retention:   Samples Without DNA
Serum and hepatic micro RNA-122

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic hepatitis C receving combination therapy with peginterferon alfa-2a and ribavirin

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • Without definite viral information during the study period (sustained viral responders or viral relapsers)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00980161

Contact: Chen-Hua Liu, MD 886-2-23123456 ext 63572 jacque_liu@mail2000.com.tw
Contact: Jia-Horng Kao, MD, PhD 886-2-23123456 ext 67307 kaojh@ntu.edu.tw

National Taiwan University Hospital, Yun-Lin Branch Recruiting
Douliou, Taiwan
Contact: Shih-Jer Hsu, MD         
Principal Investigator: Shih-Jer Hsu, MD         
Sub-Investigator: Chieh-Chang Chen, MD         
Sub-Investigator: Ming-Lun Han, MD         
Sub-Investigator: Yu-Jen Fang, MD         
Sub-Investigator: Ji-Yuh Lee, MD         
Kinmen Hospital Recruiting
Kimmen, Taiwan
Contact: Tung-Hung Su, MD         
Principal Investigator: Tung-Hung Su, MD         
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Contact: Chen-Hua Liu, MD         
Principal Investigator: Chen-Hua Liu, MD         
Principal Investigator: Jia-Horng Kao, MD, PhD         
Principal Investigator: Chun-Jen Liu, MD, PhD         
Sub-Investigator: Ming-Yang Lai, MD, PhD         
Sub-Investigator: Pei-Jer Chen, MD, PhD         
Sub-Investigator: Ding-Shinn Chen, MD         
Far Eastern Memorial Hospital Recruiting
Taipei, Taiwan
Contact: Cheng-Chao Liang, MD, BS         
Principal Investigator: Cheng-Chao Liang, MD, BS         
Taipei Municipal Hospital, Ren-Ai Branch Recruiting
Taipei, Taiwan
Contact: Chih-Lin Lin, MD, BS         
Principal Investigator: Chih-Lin Lin, MD, BS         
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Department of Health, Executive Yuan, R.O.C. (Taiwan)
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
More Information

Responsible Party: Chen-Hua Liu, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00980161     History of Changes
Other Study ID Numbers: 200908039R
First Posted: September 18, 2009    Key Record Dates
Last Update Posted: March 26, 2010
Last Verified: March 2010

Keywords provided by National Taiwan University Hospital:
Hepatitis C

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Peginterferon alfa-2a
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents