High-dose IFN and PEG IFN for Induction Therapy in Difficult to Treat Genotype 1 Patients With Chronic HCV

August 26, 2021 updated by: Foundation for Liver Research

A Comparative Study of High-dose Interferon Alfa-2a and Pegylated Interferon Alfa-2a for Induction Therapy in Difficult to Treat Genotype 1 Patients With Chronic HCV

Comparison of virological breakthrough/relapse rate after dose adjustments and sustained virological response rate will be assessed by the type of induction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to compare pharmacokinetics by IFN assays and pharmacodynamics by patient's HCVRNA suppression of 360 mug peginterferon QW, 9 MU interferon daily or 4,5 MU interferon daily in combination with 180 mug peginterferon QW in the first 4 weeks of treatment. Comparison of virological breakthrough/relapse rate after dose adjustments and sustained virological response rate will be assessed by the type of induction.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 3

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

  • Netherlands
      • Rotterdam, Netherlands, 3015 CE
        • Erasmus Medical Center

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • chronic hepatitis C
  • detectable serum HCV-RNA
  • elevated serum ALT activity documented on at least two occasions within the past 12 months, with at least one during the 90 day screening period preceding the initiation of test drug dosing
  • liver biopsy findings (during screening or within previous 12 months) consistent with active fibrosis (haemophiliacs are excluded from biopsies)
  • compensated liver disease (Child-Pugh Grade A clinical classification)
  • 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 and their fertile or potentially fertile partners must be advised to use two forms of effective contraception (combined) during treatment and during the 6 months after end of treatment

Exclusion Criteria:

  • history or other evidence of severe illness, malignancy or any other condition which would make the patient, in the opinion of the investigator, unsuitable for the study
  • women with ongoing pregnancy or breast feeding
  • therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) <3 months prior to the first dose of study drug
  • any investigational drug <6 weeks prior to the first dose of study drug positive test at screening for HBsAg, anti-HIV Ab history or other evidence of bleeding from esophageal varices, ascites, or other conditions consistent with decompensated liver disease (Child-Pugh Grade B or C clinical classification)
  • Signs or symptoms of hepatocellular carcinoma
  • history or other strong evidence of a medical condition associated with chronic liver disease other than HCV (e.g., primary hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures
  • Hb <7.5 mmol/l in women or <8.6 mmol/l in men at screening
  • any patient with an increased baseline risk for anaemia (e.g. thalassemia, spherocytosis, etc) or for whom anaemia would be medically problematic neutrophil count <1500 cells/mm3 or platelet count <80,000 cells/mm3 at screening
  • serum creatinine level >1.5 times the upper limit of normal at screening
  • history of severe psychiatric disease, especially depression
  • history of a severe seizure disorder or current anticonvulsant use
  • history of immunologically mediated disease
  • history or other evidence of chronic pulmonary disease associated with functional limitation
  • history of severe allergies
  • history of symptomatic and/or significant cardiovascular disease
  • poorly controlled diabetes mellitus
  • history of major organ transplantation with an existing functional graft
  • hyper- or hypothyroidism
  • evidence of severe retinopathy
  • evidence of drug abuse (including excessive alcohol consumption within one year before study entry

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 360 PEG IFN
360 mug peginterferon alfa-2a QW
Drug: Ribavirin
Other Names:
  • Copegus
Drug: Peginterferon alfa-2a
Other Names:
  • Pegasys
Active Comparator: 9 MU + 180 PEG IFN
9 MU interferon daily in combination with 180 mug peginterferon QW in the first 4 weeks of treatment
Drug: Ribavirin
Other Names:
  • Copegus
Drug: Interferon alfa-2a
Other Names:
  • Intron-A
Drug: Peginterferon alfa-2a
Other Names:
  • Pegasys
Active Comparator: 4,5 MU IFN + 180 PEG IFN
4,5 MU interferon daily in combination with 180 mug peginterferon QW in the first 4 weeks of treatment
Drug: Ribavirin
Other Names:
  • Copegus
Drug: Interferon alfa-2a
Other Names:
  • Intron-A
Drug: Peginterferon alfa-2a
Other Names:
  • Pegasys

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare pharmacokinetics by IFN assays and pharmacodynamics by patient's HCV RNA suppression of 360 mug peginterferon alfa-2a QW, 9 MU interferon alfa-2a daily or 4,5 interferon alfa-2a daily in combination with 180 mug peginterferon alfa-2a QW
Time Frame: week 4
week 4

Secondary Outcome Measures

Outcome Measure
Time Frame
To compare the virological breakthrough/relapse rate after dose adjustments (at 4,24,72) weeks.
Time Frame: week 4, 24 and 72
week 4, 24 and 72
To compare the sustained virological response rate at 24 weeks after end of treatment.
Time Frame: week 24 follow up
week 24 follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Foundation for Liver Research

Investigators

  • Principal Investigator: Rob J. de Knegt, MD, PhD, Erasmus Medical Center

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

February 1, 2003

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

September 27, 2006

First Submitted That Met QC Criteria

September 27, 2006

First Posted (Estimate)

September 28, 2006

Study Record Updates

Last Update Posted (Actual)

September 1, 2021

Last Update Submitted That Met QC Criteria

August 26, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCV02-01

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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