Factors Associated to Success of Hepatitis C Therapy | NCT00514111

Studies
Factors Associated to Success of Hepatitis C Therapy

NCT00514111

Sponsor

UPECLIN HC FM Botucatu Unesp

Status

Completed

Last Update Posted

Mar 20, 2009Estimated

Enrollment

100Actual

Phase

Not provided

Conditions

Hepatitis, Viral, Non-A, Non-B, Parenterally-Transmitted

Interventions

pegylated-interferon, conventional-interferon, ribavirin

Countries

Brazil

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

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Jul 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Aug 8, 2007

First Submission Date that Met QC Criteria

Aug 8, 2007

First Posted Date

Aug 9, 2007Estimated

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

Mar 19, 2009

Last Update Posted Date

Mar 20, 2009Estimated

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 aim of this study is to evaluate the sustained virologic response (RVS) in HVC patients treated with pegylated-interferon or conventional-interferon and ribavirin, and to investigate the associated factors with RVS, by means of retrospective analysis.

Detailed Description

Chronic hepatitis C virus(HVC) is a major public-health problem since it presents a long phase of clinical latency which makes its early diagnosis difficult and results in the development of a large number of cases to complications such as cirrhosis, hepatic insufficiency and hepatocarcinoma. In Brazil, it is estimated three million estimated cases to 52 thousand reports. The aim of this study is to evaluate the sustained virologic response (RVS) in HVC patients treated with pegylated-interferon or conventional-interferon and ribavirin, and to investigate the associated factors with RVS, by means of retrospective analysis.

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

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HVC Patients		HVC patients attended in SAE e HD.	Drug: pegylated-interferon, conventional-interferon, ribavirin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pegylated-interferon, conventional-interferon, ribavirin	Drug	Genotype 1: pegylated-interferon 2a or 2b plus ribavirin for 48 weeks. Genotype 3: conventional-interferon 2a or 2b plus ribavirin for 24 weeks.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HVC patients that received specific treatment with pegylated-interferon or conventional-interferon, and ribavirin

Exclusion Criteria:

No HVC infection or treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

HVC patients attended in SAE e HD.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alexandre N Barbosa, MD, MSc	UPECLIN HC FM Botucatu Unesp	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SAE e Hospital Dia de Aids		Botucatu	São Paulo	18618970	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D006526	Hepatitis C

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012254	Ribavirin
C100416	peginterferon alfa-2a
C417083	peginterferon alfa-2b

Ancestor Terms

ID	Term
D012263	Ribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides

Browse Leaves

Not provided

Browse Branches

Not provided