- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02377856
Peginterferon Plus Ribavirin Combination Therapy for Hepatitis C Six Months After Onset of Acute Infection
February 29, 2016 updated by: Ming-Lung Yu, Kaohsiung Medical University Chung-Ho Memorial Hospital
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kaohsiung, Taiwan, 807
- Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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'
|
pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 24 weeks, follow up for 24 weeks
Other Names:
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No Intervention: observation
40 patients without treatment will be followed for the clinical course for 1.5 year
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1.5 yr
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
safety issues regarding adverse events
Time Frame: 1.5 yrs
|
patient safety of pegylated interferon and ribavirin combination therapy
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1.5 yrs
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
February 1, 2016
Study Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
September 9, 2014
First Submitted That Met QC Criteria
February 26, 2015
First Posted (Estimate)
March 4, 2015
Study Record Updates
Last Update Posted (Estimate)
March 2, 2016
Last Update Submitted That Met QC Criteria
February 29, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis
- Hepatitis A
- Hepatitis C
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites
- Antineoplastic Agents
- Immunologic Factors
- Interferons
- Interferon-alpha
- Ribavirin
- Peginterferon alfa-2a
- Interferon alpha-2
Other Study ID Numbers
- KMUH-IRB-960056
- KMUH (Other Identifier: KMUH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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