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

Acute Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02377856
• Other study ID #: KMUH-IRB-960056
• Secondary ID: KMUH
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2014
• Last updated: February 29, 2016
• Start date: June 2007
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

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

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	treatment efficacy in terms of SVR rate	Efficacy - Sustained virological response (SVR), HCV RNA seronegative by PCR throughout 24-week off-treatment period.	1.5 yr	Yes
Secondary	safety issues regarding adverse events	patient safety of pegylated interferon and ribavirin combination therapy	1.5 yrs	Yes