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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01582594
• Other study ID #: OCD-200902
• Status: Terminated
• Phase: Phase 3
• First received: April 19, 2012
• Last updated: June 27, 2013
• Start date: February 2012
• Est. completion date: January 2013

Study information

• Verified date: May 2012
• Source: Johnson & Johnson Medical, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 795
• Est. completion date: January 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 90 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis C

Locations

Country	Name	City	State
China	302 military hospital of China	Beijing	Beijing
China	Chinese PLA general hospital	Beijing	Beijing
China	National institues for Food and Drug control	Beijing	Beijing
China	Ruijin hospital Shanghai Jiaotong University school of medicine	Shang hai

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Medical, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the accuracy of the CHIRON® RIBA® HCV 3.0	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	No
Secondary	the effect and applicability of different sample types on RIBA test results	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	No
Secondary	potential interference in RIBA	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	No