Peginterferon Plus Ribavirin Combination Therapy for Hepatitis C Six Months After Onset of Acute Infection

NCT ID: NCT02377856

Last Updated: 2016-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2016-02-29

Brief Summary

Patients with acute hepatitis C virus (HCV) infection usually become chronicity if viremia persists after 6 months of infection. The result of using pegylated interferon plus ribavirin combination therapy upon these patients remains to be explored

Detailed Description

Combination therapy with pegylated interferon-alpha plus ribavirin has greatly improved the treatment efficacy and is the mainstream of treatment for chronic hepatitis C infection. Current guideline suggests pegylated interferon monotherapy for patients with acute HCV infection. The efficacy might greatly improves if the treatment starts earlier. An estimation of 20 percents of patients could recover from acute infection spontaneously within 6 months after exposure,however. The present study aims to clarify the efficacy of pegylated interferon and ribavirin combination therapy for patients with hepatitis C six months after onset of acute infection

Conditions

Acute Hepatitis C

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

intervention

40 patients will receive pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 24 weeks combination treatment, followed by 24 weeks of follow-up. 'pegylated interferon alpha 2a, ribavirin'

Group Type: ACTIVE_COMPARATOR

pegylated interferon alpha 2a, ribavirin

Intervention Type: DRUG

pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 24 weeks, follow up for 24 weeks

observation

40 patients without treatment will be followed for the clinical course for 1.5 year

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

pegylated interferon alpha 2a, ribavirin

pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 24 weeks, follow up for 24 weeks

Intervention Type: DRUG

Other Intervention Names

PEGASYS®

Eligibility Criteria

Inclusion Criteria

• Male and female patients 18-80 years of age
• Patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribavirin
• Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
• Detectable serum HCV-RNA for > 6 months
• Compensated liver disease
• Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug
• All fertile males and females receiving ribavirin must be using two forms of effective contraception during treatment and during the 6 months after treatment end

Exclusion Criteria

• Women with ongoing pregnancy or breast feeding
• Present therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) within 6 months prior to the first dose of study drug
• Any investigational drug 6 weeks prior to the first dose of study drug
• Co-infection with active hepatitis A, hepatitis B and/or human immunodeficiency virus (HIV)
• History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
• Clinical evidence or history of hepatocellular carcinoma
• History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
• Neutrophil count <1500 cells/mm3 or platelet count <90,000 cells/mm3 at screening
• Serum creatinine level >1.5 times the upper limit of normal at screening
• History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease
• History of a severe seizure disorder or current anticonvulsant use
• History of immunologically mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
• History of thyroid disease poorly controlled on prescribed medications, elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease
• Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration)
• Evidence of drug abuse (including excessive alcohol consumption>40 g/day) within one year of study entry
• Inability or unwillingness to provide informed consent or abide by the requirements of the study
• Male partners of women who are pregnant
• Hgb <11 g/dL in women or <12 g/dL in men at screening
• Any patient with major thalassemia
• Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4 g/dL (as may be seen with ribavirin therapy) would not be well-tolerated
• Local or Systemic malignancy unstable status

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ming-Lung Yu

MD. PhD.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ming-Lung Yu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Medical University

Locations

Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.

Kaohsiung City, , Taiwan

Countries

Taiwan

Other Identifiers

KMUH

Identifier Type: OTHER

Identifier Source: secondary_id

KMUH-IRB-960056

Identifier Type: -

Identifier Source: org_study_id