NCT00239252

Brief Summary

Efficacy and safety is compared between interferon alfacon-1 alone and concomitant dosing of interferon alfacon-1 and ribavirin in hepatitis C patients.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

5 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

First Submitted

Initial submission to the registry

September 13, 2005

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 17, 2005

Completed
Last Updated

August 26, 2014

Status Verified

August 1, 2014

First QC Date

September 13, 2005

Last Update Submit

August 25, 2014

Conditions

Hepatitis C

Keywords

Interferon alfacon-1Virus diseaseHepatitis C

Interventions

Interferon alfacon-1DRUG

Eligibility Criteria

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

You may qualify if:

  • Hepatitis C patients (high titer, genotype1)

You may not qualify if:

  • Patients with autoimmune disorder
  • Patients with negative HBs antigen
  • Patients with hepatic cirrhosis, hepatic failure and hepatic cancer
  • Patients with depression or psychoneurotic disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Chubu Region, Japan

Location

Unknown Facility

Chugoku Region, Japan

Location

Unknown Facility

Kinki Region, Japan

Location

Unknown Facility

Kyushu Region, Japan

Location

Unknown Facility

Tohoku Region, Japan

Location

MeSH Terms

Conditions

Hepatitis CVirus Diseases

Interventions

interferon alfacon-1

Condition Hierarchy (Ancestors)

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

Study Officials

  • Clinical Development III

    Astellas Pharm. Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

October 17, 2005

Last Updated

August 26, 2014

Record last verified: 2014-08

Locations

JP(5)