Pegintron Induction Therapy in HCV Non-Responders

This study has been completed.
Sponsor:
Information provided by:
Foundation for Liver Research
ClinicalTrials.gov Identifier:
NCT00363259
First received: August 10, 2006
Last updated: NA
Last verified: August 2006
History: No changes posted
  Purpose

The purpose of this study is to compare the sustained virological response rate at 24 weeks after the end of experimental treatment (induction and 72 weeks) to that of standard 48 weeks treatment with PEG-inteferon alfa-2b and ribavirin in patients with chronic hepatitis C previous unresponsive to interferon alfa monotherapy or interferon alfa/ribavirin combination therapy.


Condition Intervention Phase
Hepatitis C
Drug: Peginterferon alfa-2b
Drug: Ribavirin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pegintron Induction Therapy in Previous Non-Responders With Chronic HCV: A Dutch Multicenter Randomized Controlled Trial. (PIT-Study)

Resource links provided by NLM:


Further study details as provided by Foundation for Liver Research:

Primary Outcome Measures:
  • sustained virological response (HCV-RNA negative 24 weeks after end of treatment)

Estimated Enrollment: 110
Study Start Date: July 2002
Estimated Study Completion Date: November 2005
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • chronic hepatitis C
  • non-response or relapse to previous interferon therapy with or without ribavirin for at least 3 months at any previous time
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363259

Locations
Netherlands
OLVG
Amsterdam, Netherlands, 1091HA
Rijnstate Ziekenhuis
Arnhem, Netherlands, 6815 AN
Atrium Medisch Centrum
Heerlen, Netherlands, 6401 CX
LUMC
Leiden, Netherlands, 2300 RC
Erasmus MC
Rotterdam, Netherlands, 3000 CA
Ziekenhuis Zeeuws Vlaanderen
Terneuzen, Netherlands, 4535 PA
UMC
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
Foundation for Liver Research
Investigators
Principal Investigator: Rob J de Knegt, MD, PhD Erasmus Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00363259     History of Changes
Other Study ID Numbers: HCV01-01
Study First Received: August 10, 2006
Last Updated: August 10, 2006
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Hepatitis C
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Peginterferon alfa-2b
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014