NCT00363259

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2002

Typical duration for phase_3

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2006

Completed
Last Updated

August 15, 2006

Status Verified

August 1, 2006

First QC Date

August 10, 2006

Last Update Submit

August 10, 2006

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

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

Interventions

Peginterferon alfa-2bDRUG
RibavirinDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

OLVG

Amsterdam, 1091HA, Netherlands

Location

Rijnstate Ziekenhuis

Arnhem, 6815 AN, Netherlands

Location

Atrium Medisch Centrum

Heerlen, 6401 CX, Netherlands

Location

LUMC

Leiden, 2300 RC, Netherlands

Location

Erasmus MC

Rotterdam, 3000 CA, Netherlands

Location

Ziekenhuis Zeeuws Vlaanderen

Terneuzen, 4535 PA, Netherlands

Location

UMC

Utrecht, 3584 CX, Netherlands

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

peginterferon alfa-2bRibavirin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Rob J de Knegt, MD, PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 10, 2006

First Posted

August 15, 2006

Study Start

July 1, 2002

Study Completion

November 1, 2005

Last Updated

August 15, 2006

Record last verified: 2006-08

Locations

NL(7)