A Registration Study to Evaluate the Performance of CHIRO... | NCT01582594

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

NCT01582594

Sponsor

Johnson & Johnson Medical, China

Status

Terminated

Last Update Posted

Jun 28, 2013Estimated

Enrollment

795Actual

Phase

Not provided

Conditions

Hepatitis C

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor's decision

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Aug 2012Actual

Completion Date

Jan 2013Actual

First Submitted Date

Apr 19, 2012

First Submission Date that Met QC Criteria

Apr 19, 2012

First Posted Date

Apr 20, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 27, 2013

Last Update Posted Date

Jun 28, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

795Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

90 Years

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
302 military hospital of China		Beijing	Beijing Municipality	100039	China
National institues for Food and Drug control

ID	Term
D006526	Hepatitis C

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human

Description

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.