A Registration Study to Evaluate the Performance of CHIRON® RIBA® HCV 3.0 SIA in HCV Antibody Detection

June 27, 2013 updated by: Johnson & Johnson Medical, China

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

Registration for license application

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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:

  1. Errors arising during testing in which the specimen cannot be repeated shall be excluded;
  2. Test results that do not pass routine quality control will not be used
  3. 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.
  4. 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johnson & Johnson Medical, China

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 28, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OCD-200902

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings