Clinical Trial on Hepatitis C - Clinical Trials Registry

Study Overview

Status

Terminated

Conditions

Hepatitis C

Detailed Description

To evaluate the accuracy of the CHIRON® RIBA® HCV 3.0 (RIBA, Investigational Product) test using known anti-HCV seropositive and seronegative specimens.

To evaluate the effect and applicability of different sample types on RIBA test results through the tests of the investigational product on serum and plasma collected from the same donors.

The specimens with HAV IgG positive, or HBsAg positive, or HEV IgG positive, or anti-HIV positive will be collected and tested for potential interference in the investigational product when used for testing the specimens infected by viruses other than HCV.

This clinical trial is for registration purpose, the study data will be submitted to Regulatory Authority (SFDA) for license application for CHIRON®RIBA®HCV 3.0 SIA reagent.

Study Type

Observational

Enrollment (Actual)

795

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- - Shang hai, China, 200027
    - Ruijin Hospital Shanghai Jiaotong University School of Medicine
- Beijing
  - Beijing, Beijing, China, 100039
    - 302 Military Hospital of China
  - Beijing, Beijing, China, 100050
    - National institues for Food and Drug control
  - Beijing, Beijing, China, 100852
    - Chinese PLA General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 90 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The specimens used for this study will be pre-tested by licensed anti-HCV screening methods and / or Nucleic acid test (NAT) in combination with the past history and will be classified as either seronegative or seropositive.

Description

Inclusion Criteria:

Residual serum or plasma specimens after routine clinical testing; fresh specimens or frozen specimens stored at -20°C or lower within 2 years after collection, with sufficient volume (≥0.5 mL) to complete all the study tests ; 2) Residual serum or plasma specimen is acceptable; matched serum and plasma with EDTA, heparin or citrate used as the anticoagulant. The collection and preparation of the specimens should comply with the standard laboratory operation procedures and the instruction for use (IFU).

Exclusion Criteria:

Severely hemolytic or turbid specimens; 2) Bacterial contaminated specimens; 3) Specimens that are improperly collected, prepared, or stored or not in accordance with package insert instructions.

Elimination criteria:

Errors arising during testing in which the specimen cannot be repeated shall be excluded;
Test results that do not pass routine quality control will not be used
Any specimen in which the case report form has incomplete data, or the case report form is missing the principal investigator's signature will not be used in the study. Case report forms with missing data will have an explanation for the missing data and should be signed by the principal investigator.
Use of unqualified reagents for specimen testing.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the accuracy of the CHIRON® RIBA® HCV 3.0 Time Frame: up to 30 weeks	To evaluate the accuracy of the CHIRON® RIBA® HCV 3.0 (RIBA, Investigational Product) test using known anti-HCV seropositive and seronegative specimens. As the study early terminated,no evaluation performed.	up to 30 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the effect and applicability of different sample types on RIBA test results Time Frame: up to 30 weeks	To evaluate the effect and applicability of different sample types on RIBA test results through the tests of the investigational product on serum and plasma collected from the same donors.As the study early terminated,no evaluation performed.	up to 30 weeks
potential interference in RIBA Time Frame: up to 30 weeks	The specimens with HAV IgG positive, or HBsAg positive, or HEV IgG positive, or anti-HIV positive will be collected and tested for potential interference in the investigational product when used for testing the specimens infected by viruses other than HCV. As the study early terminated,no evaluation performed.	up to 30 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Medical, China

Investigators

Principal Investigator: Yuanli Mao, Professor, Beijing 302 Hospital
Principal Investigator: Yanping Luo, Professor, Chinese PLA General Hospital
Principal Investigator: Xinxin Zhang, Professor, Ruijin Hospital
Principal Investigator: Tai Guo, Director, National Institites of Food and Drug control

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

January 1, 2013

Study Registration Dates

First Submitted

April 19, 2012

First Submitted That Met QC Criteria