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

NCT02377856 | Completed Phase 4

• 2 other identifiers: KMUH-IRB-960056KMUH
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Hepatitis C

Keywords

acute hepatitis C; treatment; SVR

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• safety issues regarding adverse events

  1.5 yrs

Study Arms (2)

intervention

ACTIVE COMPARATOR

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

observation

NO INTERVENTION

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

Interventions

pegylated interferon alpha 2a, ribavirin DRUG

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

Also known as: PEGASYS®

intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.

Kaohsiung City, 807, Taiwan

Location

MeSH Terms

Interventions

Ribavirin; peginterferon alfa-2a

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Ming-Lung Yu, MD, PhD

  Kaohsiung Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. PhD.

Study Record Dates

• First Submitted: September 9, 2014
• First Posted: March 4, 2015
• Study Start: June 1, 2007
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: March 2, 2016

Record last verified: 2016-02

Locations

TW (1)