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

NCT00543244 | Unknown DMC

• 1 other identifier: 200709053R
• Study Type: observational
• Target: 300
• Locations: 2 countries
• Sites: 7

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.

Conditions

Chronic Hepatitis C

Keywords

Chronic hepatitis C; Pegylated interferon; Ribavirin; Virokinetics

Outcome Measures

Primary Outcomes (1)

• Sustained virologic response (SVR)

  1~1.5 years

Study Arms (1)

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

Interventions

Pegylated interferon alfa and ribavirin DRUG

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)

Also known as: Pegasys plus Robatrol, Peg-Intron plus Rebetol

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

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)
• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (7)

Faculty of Life Sciences, Bar-Ilan University

Ramat Gan, Israel

RECRUITING

National Taiwan University Hospital, Yun-Lin Branch

Douliu, Taiwan

RECRUITING

Taichung Veterans General Hospital

Taichung, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Buddhist Tzu Chi General Hospital

Taipei, Taiwan

RECRUITING

Far Eastern Memorial Hospital

Taipei, Taiwan

RECRUITING

Ren-Ai Branch, Taipei Municipal Hospital

Taipei, Taiwan

RECRUITING

Related Publications (24)

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  PMID: 11583749 BACKGROUND

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• Hadziyannis SJ, Sette H Jr, Morgan TR, Balan V, Diago M, Marcellin P, Ramadori G, Bodenheimer H Jr, Bernstein D, Rizzetto M, Zeuzem S, Pockros PJ, Lin A, Ackrill AM; PEGASYS International Study Group. Peginterferon-alpha2a and ribavirin combination therapy in chronic hepatitis C: a randomized study of treatment duration and ribavirin dose. Ann Intern Med. 2004 Mar 2;140(5):346-55. doi: 10.7326/0003-4819-140-5-200403020-00010.

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• Lee SD, Yu ML, Cheng PN, Lai MY, Chao YC, Hwang SJ, Chang WY, Chang TT, Hsieh TY, Liu CJ, Chen DS. Comparison of a 6-month course peginterferon alpha-2b plus ribavirin and interferon alpha-2b plus ribavirin in treating Chinese patients with chronic hepatitis C in Taiwan. J Viral Hepat. 2005 May;12(3):283-91. doi: 10.1111/j.1365-2893.2005.00590.x.

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  PMID: 12407599 BACKGROUND

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  PMID: 9756471 BACKGROUND

• Lee WM, Reddy KR, Tong MJ, Black M, van Leeuwen DJ, Hollinger FB, Mullen KD, Pimstone N, Albert D, Gardner S. Early hepatitis C virus-RNA responses predict interferon treatment outcomes in chronic hepatitis C. The Consensus Interferon Study Group. Hepatology. 1998 Nov;28(5):1411-5. doi: 10.1002/hep.510280533.

  PMID: 9794929 BACKGROUND

• Orito E, Mizokami M, Suzuki K, Ohba K, Ohno T, Mori M, Hayashi K, Kato K, Iino S, Lau JY. Loss of serum HCV RNA at week 4 of interferon-alpha therapy is associated with more favorable long-term response in patients with chronic hepatitis C. J Med Virol. 1995 Jun;46(2):109-15. doi: 10.1002/jmv.1890460205.

  PMID: 7636496 BACKGROUND

• Colombatto P, Civitano L, Oliveri F, Coco B, Ciccorossi P, Flichman D, Campa M, Bonino F, Brunetto MR. Sustained response to interferon-ribavirin combination therapy predicted by a model of hepatitis C virus dynamics using both HCV RNA and alanine aminotransferase. Antivir Ther. 2003 Dec;8(6):519-30.

  PMID: 14760885 BACKGROUND

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MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Ribavirin; peginterferon alfa-2a; peginterferon alfa-2b

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Jia-Horng Kao, MD, PhD

  National Taiwan University Hospital

  STUDY CHAIR

• Avidan Uriel Neumann, PhD

  Faculty of Life Sciences, Bar-Ilan University, Ramat-Gan, Israel

  PRINCIPAL INVESTIGATOR

• Chen-Hua Liu, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jia-Horng Kao, MD, PhD

CONTACT

886-2-23123456; kaojh@ntu.edu.tw

Avidan Uriel Neumann, PhD

CONTACT

972-3-531-7970; neumann@mail.biu.ac.il

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 10, 2007
• First Posted: October 12, 2007
• Study Start: January 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: December 1, 2008
• Last Updated: November 21, 2008

Record last verified: 2008-02

Locations

TW (6); IL (1)