NCT00144469

Brief Summary

This study evaluated the efficacy and safety of the combination of peginterferon alfa-2a plus ribavirin in treatment-naïve patients with HCV genotype 1b infection, compared with peginterferon alfa-2a monotherapy. Additionally, the study evaluated the efficacy and safety of the combination of peginterferon alfa-2a plus ribavirin in patients with CHC who had failed to respond to previous conventional-interferon based therapy.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2002

Typical duration for phase_3

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
Last Updated

February 2, 2009

Status Verified

January 1, 2009

First QC Date

September 2, 2005

Last Update Submit

January 29, 2009

Conditions

Chronic Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • Sustained virological response, defined as undetectable HCV-RNA (<50IU per milliliter) after 24 weeks of untreated follow-up (week 72).

Secondary Outcomes (2)

  • Biochemical response (normalization of serum alanine aminotransferase activity),

  • Virological response (HCV-RNA <50IU per milliliter) at the end of therapy.

Interventions

peginterferon alfa-2aDRUG
rivavirinDRUG

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients with quantifiable serum HCV-RNA (≥500 IU/mL))
  • elevated serum alanine aminotransferase activity (≥45 IU per liter)within six months of screening
  • liver biopsy findings consistent with a diagnosis of chronic hepatitis C.

You may not qualify if:

  • Patients with neutropenia (fewer than 1,500 neutrophils per cubic millimeter)
  • leukopenia (fewer than 3,000 white blood cells per cubic millimeter)
  • thrombocytopenia (fewer than 90,000 platelets per cubic millimeter)
  • anemia (less than 12 g hemoglobin per deciliter )
  • hepatitis B co-infection
  • decompensated liver disease
  • organ transplant
  • creatinine clearance less than 50 milliliters per minute
  • poorly controlled psychiatric disease
  • poorly controlled diabetes
  • malignant neoplastic disease
  • severe cardiac or chronic pulmonary disease
  • immunologically mediated disease
  • retinopathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hirokazu Furuta

    Chugai Pharmaceutical

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 5, 2005

Study Start

May 1, 2002

Study Completion

March 1, 2005

Last Updated

February 2, 2009

Record last verified: 2009-01