Prospective Observational Study of Disease Progression in... | NCT02011932

Studies
Prospective Observational Study of Disease Progression in Chronic Hepatitis C

NCT02011932

Sponsor

Beijing YouAn Hospital

Status

Active, not recruiting

Last Update Posted

Dec 17, 2013Estimated

Enrollment

133Actual

Phase

Not provided

Conditions

Hepatitis C, Chronic
Disease Progression
Liver Cirrhosis

Interventions

Not provided

Countries

Not provided

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

Dec 2013

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Jun 2011Actual

Completion Date

Jul 2030Estimated

First Submitted Date

Dec 6, 2013

First Submission Date that Met QC Criteria

Dec 10, 2013

First Posted Date

Dec 16, 2013Estimated

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

Dec 13, 2013

Last Update Posted Date

Dec 17, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zhongping Duan, Associate Dean,Professor,Chief Physician, Beijing YouAn HospitalPrincipal Investigator

Lead Sponsor

Beijing YouAn HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of this study is to determine the progression of chronic hepatitis C patients infected by paid plasma donation,and explore the possible pathogenic mechanisms of disease progression in chronic hepatitis C.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

133Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fibrosis progression rate		20 years
The incidence of cirrhosis		20 years
Risk factors for the occurrence of cirrhosis		20 years

Secondary Outcomes

Measure	Description	Time Frame
The incidence of hepatocellular carcinoma		20 years
Number of participants with chronic hepatitis C-related complications		20 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All these patients had a definite history of regular plasma donations with repeated blood cell re-transfusions.
The Hepatitis C Virus antibody was positive.
All patients did not receive interferon therapy before being recruited.

Exclusion Criteria:

Patients with evidences for other forms of liver diseases.
The coinfection with hepatitis B virus or other virus.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

The plasma donors were primarily chosen from healthy farmers and agricultural workers living in a remote small city in the Northwest China.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zhongping Duan, Ph.D.,M.D.	Beijing YouAn Hospital	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12407575	Background	Seeff LB. Natural history of chronic hepatitis C. Hepatology. 2002 Nov;36(5 Suppl 1):S35-46. doi: 10.1053/jhep.2002.36806.
9121257	Background	Poynard T, Bedossa P, Opolon P. Natural history of liver fibrosis progression in patients with chronic hepatitis C. The OBSVIRC, METAVIR, CLINIVIR, and DOSVIRC groups. Lancet. 1997 Mar 22;349(9055):825-32. doi: 10.1016/s0140-6736(96)07642-8.

Label	Type	Description	Intervention Names
Healthy volunteers
Chronic hepatitis C

ID	Term
D006526	Hepatitis C
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

ID	Term
D019698	Hepatitis C, Chronic
D018450	Disease Progression
D008103	Liver Cirrhosis