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

This study has been terminated.
(Sponsor's decision)
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Medical, China
ClinicalTrials.gov Identifier:
NCT01582594
First received: April 19, 2012
Last updated: June 27, 2013
Last verified: May 2012
  Purpose

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


Condition Phase
Hepatitis C
Phase 3

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Registration Study to Evaluate the Performance of CHIRON® RIBA® HCV 3.0 SIA in HCV Antibody Detection

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Medical, China:

Primary Outcome Measures:
  • To evaluate the accuracy of the CHIRON® RIBA® HCV 3.0 [ Time Frame: up to 30 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • the effect and applicability of different sample types on RIBA test results [ Time Frame: up to 30 weeks ] [ Designated as safety issue: No ]
    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.

  • potential interference in RIBA [ Time Frame: up to 30 weeks ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

A minimum of 1000 qualified specimens shall be collected, including at least 350 anti-HCV seropositive specimens.

To further evaluate RIBA test specificity in HAV IgG positive, HBsAg positive, HEV IgG positive and anti-HIV positive specimens, approximately 30 specimens of each viral infection will be included in the study.

A minimum of 60 matched plasma and serum specimens will be collected to evaluate the applicability of the investigational product on different types of samples, including at least 30% of anti-HCV seropositive specimens.


Enrollment: 795
Study Start Date: February 2012
Study Completion Date: January 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   1 Year to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01582594

Locations
China, Beijing
302 military hospital of China
Beijing, Beijing, China, 100039
Chinese PLA general hospital
Beijing, Beijing, China, 100852
National institues for Food and Drug control
Beijing, Beijing, China, 100050
China
Ruijin hospital Shanghai Jiaotong University school of medicine
Shang hai, China, 200027
Sponsors and Collaborators
Johnson & Johnson Medical, China
Investigators
Principal Investigator: Yuanli Mao, Professor 302 military hospital of China
Principal Investigator: Yanping Luo, Professor Chinese PLA General Hospital
Principal Investigator: Xinxin Zhang, Professor Ruijin hospital Shanghai Jiaotong University school of medicine
Principal Investigator: Tai Guo, Director National Institites of Food and Drug control
  More Information

No publications provided

Responsible Party: Johnson & Johnson Medical, China
ClinicalTrials.gov Identifier: NCT01582594     History of Changes
Other Study ID Numbers: OCD-200902
Study First Received: April 19, 2012
Last Updated: June 27, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Johnson & Johnson Medical, China:
1000 residual serum/plasma samples
anti-HCV seronegative or seropositive

Additional relevant MeSH terms:
Hepatitis C
Digestive System Diseases
Flaviviridae Infections
Hepatitis
Hepatitis, Viral, Human
Liver Diseases
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 27, 2014