Comparison in Efficacy and Safety Between Interferon Alfacon-1 Alone and Concomitant Dosing With Ribavirin for the Treatment of Hepatitis C

NCT ID: NCT00239252

Last Updated: 2014-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatitis C

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Interferon alfacon-1

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Hepatitis C patients (high titer, genotype1)

Exclusion Criteria

* Patients with autoimmune disorder
* Patients with negative HBs antigen
* Patients with hepatic cirrhosis, hepatic failure and hepatic cancer
* Patients with depression or psychoneurotic disorder
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Schering-Plough

INDUSTRY

Sponsor Role collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Development III

Role: STUDY_CHAIR

Astellas Pharm. Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chubu Region, , Japan

Site Status

Chugoku Region, , Japan

Site Status

Kinki Region, , Japan

Site Status

Kyushu Region, , Japan

Site Status

Tohoku Region, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B6431/HCT1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.