Observational,Prospective Study to Develop and Validate a... | NCT01884402

Status Module

Record Verification Date

Sep 2014

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

Oct 2010

Primary Completion Date

May 2014Actual

Completion Date

Aug 2014Actual

First Submitted Date

Jun 18, 2013

First Submission Date that Met QC Criteria

Jun 20, 2013

First Posted Date

Jun 24, 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

Sep 3, 2014

Last Update Posted Date

Sep 4, 2014Estimated

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

Primary objective:

• Develop and validate a tool towards patients with chronic hepatitis C genotype 1 and 4 to allow optimize treatment.

Detailed Description

This Tool:

Predicting the overall impact of prognostic factors (including the new factor of genetic polymorphism of the IL28B) on Sustained Viral Response (SVR).
Identify those patients most likely to respond.
Therapy and therefore optimize resources

The validation tool will check into clinical practice its predictive power (it will consider its ability to calibrate and discriminate) and make correct inferences and interpretations of the scores obtained when applying.

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

770Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pegasys, injection subcutaneous		HCV patients monoinfected or coinfected genotype 1/4 treated with Peginterferon alfa-2a and Ribavirin	Drug: Peginterferon alfa-2a Drug: Ribavirin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Peginterferon alfa-2a	Drug	Treatment as usual clinical practice	Pegasys, injection subcutaneous

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sustained Viral Response (RVS)	Measurement of HCV RNA negativization 24 weeks after treatment	1 ½ years (72 weeks)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with > 18 years old.
Patients diagnosed with chronic hepatitis C in the presence of HCV RNA in plasma that meet criteria for initiating antiviral therapy in routine clinical practice conditions.
Patients Genotype 1 and 4.
Patients with the results of all the factors evaluable at the time of inclusion.
Patients who have accepted their participation in the study through informed consent.

Exclusion Criteria:

Patients previously treated with interferon (IFN) and ribavirin (RBV).
Patients with genotype 2, 3, 5 and 6.
Patients with co-infection with hepatitis B.
Patients with other liver diseases.
Patients with any contraindications to the drugs used in the treatment of hepatitis C.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with chronic hepatitis C genotype 1 and 4 mono-or co-infected with HIV who meet the selection criteria described.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Manuel Romero-Gómez, Medicine	Hospital de Valme & ciberEHD	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fundación Pública Andaluza para la Gestión de la investigación en salud de Sevilla (FISEVI)		Seville	Sevilla		Spain

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention 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
D006525	Hepatitis, Viral, Human
D014777	Virus Diseases
D018178	Flaviviridae Infections
D012327	RNA Virus Infections
D006521	Hepatitis, Chronic
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

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

ID	Term
C100416	peginterferon alfa-2a
D012254	Ribavirin