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

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ClinicalTrials.gov Identifier: NCT02377856
Recruitment Status : Completed
First Posted : March 4, 2015
Last Update Posted : March 2, 2016
Sponsor:
Information provided by (Responsible Party):
Ming-Lung Yu, Kaohsiung Medical University Chung-Ho Memorial Hospital

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

Condition or disease Intervention/treatment Phase
Acute Hepatitis C Drug: pegylated interferon alpha 2a, ribavirin Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Peginterferon Plus Ribavirin Combination Therapy for Hepatitis C Six Months After Onset of Acute Infection
Study Start Date : June 2007
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016


Arm Intervention/treatment
Active Comparator: 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'
Drug: 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
Other Name: PEGASYS®

No Intervention: observation
40 patients without treatment will be followed for the clinical course for 1.5 year



Primary Outcome Measures :
  1. treatment efficacy in terms of SVR rate [ Time Frame: 1.5 yr ]
    Efficacy - Sustained virological response (SVR), HCV RNA seronegative by PCR throughout 24-week off-treatment period.


Secondary Outcome Measures :
  1. safety issues regarding adverse events [ Time Frame: 1.5 yrs ]
    patient safety of pegylated interferon and ribavirin combination therapy



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02377856


Locations
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Taiwan
Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.
Kaohsiung, Taiwan, 807
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
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Principal Investigator: Ming-Lung Yu, MD, PhD Kaohsiung Medical University

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Responsible Party: Ming-Lung Yu, MD. PhD., Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT02377856     History of Changes
Other Study ID Numbers: KMUH-IRB-960056
KMUH ( Other Identifier: KMUH )
First Posted: March 4, 2015    Key Record Dates
Last Update Posted: March 2, 2016
Last Verified: February 2016

Keywords provided by Ming-Lung Yu, Kaohsiung Medical University Chung-Ho Memorial Hospital:
acute hepatitis C
treatment
SVR

Additional relevant MeSH terms:
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Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Interferon alpha-2
Ribavirin
Interferon-alpha
Peginterferon alfa-2a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs