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Early Prediction of Successful Treatment for Chronic Hepatitis C Virus Infection in Taiwan

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ClinicalTrials.gov Identifier: NCT00543244
Recruitment Status : Unknown
Verified February 2008 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : October 12, 2007
Last Update Posted : November 21, 2008
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:

Hepatitis C virus (HCV) infection is a global health problem, which may lead to chronic hepatitis, cirrhosis, hepatic decompensation and hepatocellular carcinoma (HCC). Recently, treatment with peginterferon alfa plus ribavirin has become the standard of care for patients with chronic hepatitis C. While genotype 2 patients can have higher sustained virologic response (SVR) rates to 80-90%, genotype 1 patients generally have low SVR rates of only 40-50%. In contrast, genotype 1 Taiwanese patients have superior SVR rates than those in Western countries. Despite the overall improved response to this combination therapy, more than 75% of patients suffer from treatment-related adverse events and the costs remain high, which make individualized therapy of paramount importance to maximize treatment response and minimize adverse events.

HCV viral kinetics with interferon-based therapies have been studied recently to evaluate patient responses. Early viral kinetics shown to have favorable SVR rates, which make shorter treatment duration possible. However, different viral kinetics were found through ethnicity. Recently, a pilot study to evaluate the viral kinetics of 6 Taiwanese patients with HCV infection who received peginterferon alfa plus ribavirin therapy has shown superior early viral kinetics to those in Caucasian patients. Based on the favorable SVR rates in treating Taiwanese patients with chronic hepatitis C, the investigators aimed to conduct a large confirmatory study to evaluate the viral kinetics and try to define the optimal treatment for these patients.


Condition or disease Intervention/treatment
Chronic Hepatitis C Drug: Pegylated interferon alfa and ribavirin

Detailed Description:

Hepatitis C virus (HCV) infection is a global health problem, which may lead to chronic hepatitis, cirrhosis, hepatic decompensation and hepatocellular carcinoma (HCC). [1,2] Recently, treatment with peginterferon alfa plus ribavirin has become the standard of care for patients with chronic hepatitis C. While genotype 2 patients can have higher sustained virologic response (SVR) rates to 80-90%, genotype 1 patients generally have low SVR rates of only 40-50%. [3-5] In contrast, genotype 1 Taiwanese patients have superior SVR rates that those in Western countries. [6,7] Despite the overall improved response to this combination therapy, more than 75% of patients suffer from treatment-related adverse events and the costs remain high, [8,9] which make individualized therapy of paramount importance to maximize treatment response and minimize adverse events.

HCV viral kinetics with interferon-based therapies have been studied recently to evaluate patient responses. [10-14] Early viral kinetics shown to have favorable SVR rates, which make shorter treatment duration possible. [15-18] However, different viral kinetics were found through ethnicity. [19-23] Recently, a pilot study to evaluate the viral kinetics of 6 Taiwanese patients with HCV infection who received peginterferon alfa plus ribavirin therapy has shown superior early viral kinetics to those in Caucasian patients. [24] Based on the favorable SVR rates in treating Taiwanese patients with chronic hepatitis C, the investigators aimed to conduct a large confirmatory study to evaluate the viral kinetics and try to define the optimal treatment for these patients.


Study Design

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Early Prediction of Successful Treatment for Chronic Hepatitis C Virus Infection in Taiwan
Study Start Date : January 2006
Estimated Primary Completion Date : October 2008
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
1
Patients with chronic hepatitis C who receive pegylated interferon plus ribavirin for 24 weeks (genotype 1 or 2) and for 48 weeks (genotype 1)
Drug: Pegylated interferon alfa and ribavirin

Pegylated interferon alfa-2a 180 ug/week or pegylated interferon alfa-2b 1.5 ug/kg/week Ribavrin 800-1200 mg/day (genotype 1: < 75 kg 1000 mg/day, >=75 kg 1200 mg/day; genotype 2: 800 mg/day)

HCV genotype: baseline (Day 0) HCV RNA (real time PCR test): baseline (Day 0), Day 1 (4,8,12 hours after pegylated interferon + ribavirin), Day 2 (24,36 hours), Day 3(48 hours), Day 4 (72 hours), Day 5 (96 hours), Week 2,4,6,8,12,16,20,24, and 28,32,36,40,44,48,72 (for genotype 1 with 48 weeks of treatment), and 48 (for genotype 1 or 2 with 24 weeks of treatment)

Other Names:
  • Pegasys plus Robatrol
  • Peg-Intron plus Rebetol


Outcome Measures

Primary Outcome Measures :
  1. Sustained virologic response (SVR) [ Time Frame: 1~1.5 years ]

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:   Probability Sample
Study Population
Patients with chronic hepatitis C virus infection who receive pegylated interferon plus ribavirin for an overall of 24-48 weeks
Criteria

Inclusion Criteria:

  • Treatment naïve
  • Over 18 years old
  • Anti-HCV (Abbott HCV EIA 2.0, Abbott Diagnostic, Chicago, IL) positive > 6 months
  • Detectable serum quantitative HCV-RNA (Cobas Amplicor HCV Monitor v2.0, Roche Molecular Systems, Pleasanton, CA) with dynamic range 600~< 500,000 IU/ml
  • 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

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)
  • 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
  • Unwilling to receive serial blood sampling during the study
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): NCT00543244


Contacts
Contact: Jia-Horng Kao, MD, PhD 886-2-23123456 ext 7307 kaojh@ntu.edu.tw
Contact: Avidan Uriel Neumann, PhD 972-3-531-7970 neumann@mail.biu.ac.il

Locations
Israel
Faculty of Life Sciences, Bar-Ilan University Recruiting
Ramat-Gan, Israel
Principal Investigator: Avidan Uriel Neumann, MD, PhD         
Taiwan
National Taiwan University Hospital, Yun-Lin Branch Recruiting
Douliou, Taiwan
Principal Investigator: Shih-Jer Hsu, MD         
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan
Principal Investigator: Sheng-Shun Yang, MD         
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Principal Investigator: Jia-Horng Kao, MD, PhD         
Sub-Investigator: Chen-Hua Liu, MD         
Sub-Investigator: Ding-Shinn Chen, MD         
Sub-Investigator: Ming-Yang Lai, MD, PhD         
Sub-Investigator: Pei-Jer Chen, MD, PhD         
Sub-Investigator: Chun-Jen Liu, MD,PhD         
Buddhist Tzu Chi General Hospital Recruiting
Taipei, Taiwan
Principal Investigator: Ching-Sheng Hsu, MD         
Sub-Investigator: Chia-Chi Wang, MD         
Far Eastern Memorial Hospital Recruiting
Taipei, Taiwan
Principal Investigator: Cheng-Chao Liang, MD         
Ren-Ai Branch, Taipei Municipal Hospital Recruiting
Taipei, Taiwan
Principal Investigator: Chih-Lin Lin, MD         
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Investigators
Study Chair: Jia-Horng Kao, MD, PhD National Taiwan University Hospital
Principal Investigator: Avidan Uriel Neumann, PhD Faculty of Life Sciences, Bar-Ilan University, Ramat-Gan, Israel
Principal Investigator: Chen-Hua Liu, MD National Taiwan University Hospital
More Information

Publications:

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00543244     History of Changes
Other Study ID Numbers: 200709053R
First Posted: October 12, 2007    Key Record Dates
Last Update Posted: November 21, 2008
Last Verified: February 2008

Keywords provided by National Taiwan University Hospital:
Chronic hepatitis C
Pegylated interferon
Ribavirin
Virokinetics

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Ribavirin
Interferon-alpha
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs