Fluvastatin, Rosuvastatin Added to Pegylated Interferon a... | NCT00487318

Studies
Fluvastatin, Rosuvastatin Added to Pegylated Interferon and Ribavirin

NCT00487318

Sponsor

Bader, Ted, M.D.

Status

Completed

Last Update Posted

Aug 21, 2012Estimated

Enrollment

40Actual

Phase

Phase 2

Conditions

Chronic Hepatitis C

Interventions

standard of care
fluvastatin

Countries

United States

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

Aug 2012

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

Jun 2007

Primary Completion Date

Oct 2010Actual

Completion Date

Oct 2010Actual

First Submitted Date

Jun 15, 2007

First Submission Date that Met QC Criteria

Jun 15, 2007

First Posted Date

Jun 18, 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

Aug 20, 2012

Last Update Posted Date

Aug 21, 2012Estimated

Name	Class
US Department of Veterans Affairs	FED

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

Hypothesis: addition of fluvastatin will increase the cure rate of standard anti-HCV therapy. Summary: This trial is limited to veterans in Oklahoma who qualify for care with the Veterans Administration. It is a randomized control format including genotypes 1 and 3. There will also be pilot arms for HCV carriers who present for screening already on a statin, who will be allowed to stay on their current statin or switched to another statin. In all ways, standard therapy as noted on pegylated interferon and ribavirin will be given per FDA package insert.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1 Plus statin	Experimental	The addition of fluvastatin or rosuvastatin or other statins to the standard of care of peginterferon and ribavirin.	Drug: fluvastatin
2	Active Comparator	Administration of the standard of care for hepatitis C of peginterferon and ribavirin.	Drug: standard of care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
standard of care	Drug	peginterferon/RBV	2
fluvastatin

Measure	Description	Time Frame
Sustained Viral response		72 weeks

Measure	Description	Time Frame
Viral load at 4, 12 and 24 weeks		24 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Not previously treated.
Off alcohol and marijuana for 6 months
HCV RNA positive

Exclusion Criteria:

HIV positive
Advanced liver disease
Advanced cardiopulmonary disease
Chronic renal failure

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
Ted F Bader, MD	OUHSC and VAMC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Veterans Administration Medical Center		Oklahoma City	Oklahoma	73104	United States

Condition Browse Module

MeSH Terms

ID	Term
D019698	Hepatitis C, Chronic
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
D059039	Standard of Care
D000077340	Fluvastatin

Ancestor Terms

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation

Browse Leaves

Not provided

Browse Branches

Not provided