HCV Genotype 1a Shows a Better Virological Response to An... | NCT01342003

Studies
HCV Genotype 1a Shows a Better Virological Response to Antiviral Therapy Than HCV Genotype 1b

NCT01342003

Sponsor

Azienda Ospedaliera San Camillo Forlanini

Status

Completed

Last Update Posted

Apr 26, 2011Estimated

Enrollment

388Actual

Phase

Not provided

Conditions

Chronic Hepatitis C

Interventions

Not provided

Countries

Italy

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

Oct 2010

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

Feb 2007

Primary Completion Date

Jul 2010Actual

Completion Date

Oct 2010Actual

First Submitted Date

Apr 25, 2011

First Submission Date that Met QC Criteria

Apr 25, 2011

First Posted Date

Apr 26, 2011Estimated

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 25, 2011

Last Update Posted Date

Apr 26, 2011Estimated

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

Sustained virological response (SVR) to antiviral therapy in patients with chronic hepatitis C genotype 1 according to subtype (1a vs.1b) has not been extensively investigated. This observational study was carried out on a large group of "naïve" HCV patients to evaluate difference, if any, between HCV genotype 1 subtype 1a and 1b on the response to treatment with peginterferon (Peg-IFN) plus ribavirin.

Detailed Description

Despite the challenging perspective of the new antiviral drugs directly acting on hepatitis C viral replication such as protease and polymerase inhibitors, nowadays the standard treatment in genotype 1-chronic hepatitis C (CHC) is the combination of peghylated interferon (PEG-IFN) and ribavirin for 48 weeks. It has been extensively shown that patients infected with HCV genotype 1 have a lower rate of viral response than those infected with genotype 2 and 3. In large randomized multinational trials, sustained virological response (SVR) of around 50% has been obtained with peginterferon α2a plus ribavirin in the more difficult to treat subgroup of patients infected with HCV genotype 1. Furthermore, advanced fibrosis is a predictive factor of non response to antiviral treatment in genotype 1 virus [5-7]. Very few studies have evaluated SVR difference, if any, between subtypes 1a and 1b.

We have carried out an observational study on a large cohort of HCV "naïve" patients to evaluate the influence of HCV subtypes 1 on the response to treatment with Peg-INF plus ribavirin.

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

388Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Subtype 1a		subtype 1a patients treated with peginterferon plus ribavirin
subtype 1b		subtype 1b patients treated with peginterferon plus ribavirin

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary end point was sustained undetectable serum HCVRNA 24 weeks after treatment cessation (SVR).	The primary end point was sustained undetectable serum HCVRNA 24 weeks after treatment cessation (Sustained virological response).	24 weeks after treatment cessation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

eligible subjects were naïve infected with HCV genotype 1 virus meeting the internationally recognised criteria for treatment (elevation of aminotransferases, inflammation and or fibrosis at liver biopsy).

Exclusion Criteria:

infection with human immunodeficiency virus (HIV) or hepatitis B virus (HBV)
alcohol intake greater than 20 gr daily
the presence of active drug abuse, chronic systemic disease, psychiatric disorders, autoimmune disease, pregnancy or lactation.

Accepts Healthy Volunteers

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

Three hundred and eighty-eight patients were included in the study. One hundred and sixty-five were HCV genotype 1 subtype 1a (42.5%) while two hundred twenty-three were of subtype 1b (57.5%).

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adriano M Pellicelli, MD	AO Scamilloforlanini Rome Italy	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AO San Camillo Forlanini		Rome	Italy	00142	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23157720	Derived	Pellicelli AM, Romano M, Stroffolini T, Mazzoni E, Mecenate F, Monarca R, Picardi A, Bonaventura ME, Mastropietro C, Vignally P, Andreoli A, Marignani M, D'Ambrosio C, Miglioresi L, Nosotti L, Mitidieri O, Gentilucci UV, Puoti C, Barbaro G, Barlattani A, Furlan C, Barbarini G; CLEO Group. HCV genotype 1a shows a better virological response to antiviral therapy than HCV genotype 1b. BMC Gastroenterol. 2012 Nov 16;12:162. doi: 10.1186/1471-230X-12-162.

ID	Term
D019698	Hepatitis C, Chronic
D006526	Hepatitis C

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