NCT00441493

Brief Summary

This is a dose finding and efficacy trial for fluvastatin versus hepatitis C.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 1, 2007

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

July 27, 2012

Status Verified

September 1, 2006

Enrollment Period

6 months

First QC Date

February 27, 2007

Last Update Submit

July 26, 2012

Conditions

Hepatitis C

Keywords

Hepatitis Cfluvastatin

Outcome Measures

Primary Outcomes (1)

  • Viral Load Reduction, Liver test changes

Interventions

fluvastatinDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HCV RNA positive

You may not qualify if:

  • Testing positive for alcohol or marijuana

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

Fluvastatin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Ted Bader, MD

    VA Medical Center and University of Oklahoma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV

Study Record Dates

First Submitted

February 27, 2007

First Posted

March 1, 2007

Study Start

September 1, 2006

Primary Completion

March 1, 2007

Study Completion

September 1, 2007

Last Updated

July 27, 2012

Record last verified: 2006-09

Locations

US(1)