Interferon α 2b Pharmacovigilance Study | NCT01841775

Studies
Interferon α 2b Pharmacovigilance Study

NCT01841775

Sponsor

The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

Status

Completed

Last Update Posted

Apr 29, 2013Estimated

Enrollment

85Actual

Phase

Phase 4

Conditions

Hepatitis C, Chronic

Interventions

interferon α 2b + 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

Official Title

Pharmacovigilance Study of the Interferon α 2b Produced by Bio-Manguinhos / Fiocruz and Used by Genotype 2/3 Chronic Hepatitis C Patients (Estudo de farmacovigilância da Alfainterferona 2b Humana Recombinante Produzida Por Bio-Manguinhos - Fiocruz, Utilizada em Portadores de Hepatite C crônica genótipos 2 e 3 Atendidos Pelo Programa de Medicamentos de Dispensação em Caráter Excepcional no Estado do Rio de Janeiro)

Status Module

Record Verification Date

Apr 2013

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

May 2009

Primary Completion Date

Sep 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Apr 19, 2013

First Submission Date that Met QC Criteria

Apr 24, 2013

First Posted Date

Apr 29, 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

Apr 24, 2013

Last Update Posted Date

Apr 29, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)OTHER

Collaborators

Name	Class
Hospital Federal de Bonsucesso	OTHER
Hospital Universitário Clementino Fraga Filho	OTHER

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

Multicenter prospective follow-up of a not controlled chronic hepatitis C genotypes 2/3 patients cohort with treatment indication with interferon α 2b and ribavirin for 24 weeks, and the verification of sustained virological response at week 48.

The eligibility criteria and outcome measures followed the Clinical Protocol and Therapeutic Guidelines for Chronic Viral Hepatitis C, published by the Ministry of Health:

http://portal.saude.gov.br/portal/arquivos/pdf/pcdt\_hepatite\_c\_2011\_retificado.pdf

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

85Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
interferon α 2b + ribavirin	Drug	interferon α 2b: 3.000.000 IU SUBQ 3 times / wk for 24 weeks ribavirin 250 mg: 15mg/kg/day,ORALLY twice a day for 24 weeks

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events	Diary for recording adverse events by patients daily; Monthly follow-up interview with MD and PharmD	Up to 24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Sustained virological response		24 weeks after finishing treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Genotype 2/3 Chronic Hepatitis C confirmed by biomolecular technology (RNAVHC);
Treatment naive;
Signing the Informed Consent Form;
Eligibility criteria and outcome measures followed the Clinical Protocol and Therapeutic Guidelines for Chronic Viral Hepatitis C, published by the Ministry of Health: http://portal.saude.gov.br/portal/arquivos/pdf/pcdt\_hepatite\_c\_2011\_retificado.pdf

Exclusion Criteria:

Serious adverse events;
Intolerance to treatment;
Lost to follow up.

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eliane M. dos Santos, MD, MSc	The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)	Principal Investigator
Paulo Roberto G. dos Santos, PharmD, MSc	The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)	Study Director
Deborah A. da Conceição, BScN	The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Federal de Bonsucesso (Bonsucesso Federal Hospital)		Rio de Janeiro	Rio de Janeiro	21041-030	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D019698	Hepatitis C, Chronic

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012254	Ribavirin

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided