Fluvastatin, Rosuvastatin Added to Pegylated Interferon and Ribavirin

NCT00487318 | Completed Phase 2

• 1 other identifier: 13358
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis C

Keywords

fluvastatin; hepatitis C; chronic hepatitis C; not previously treated with pegylated interferon and ribavirin

Outcome Measures

Primary Outcomes (1)

• Sustained Viral response

  72 weeks

Secondary Outcomes (1)

• Viral load at 4, 12 and 24 weeks

  24 weeks

Study Arms (2)

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

standard of care DRUG

peginterferon/RBV

2

fluvastatin DRUG

Add fluvastatin at 20-40 mg/day to standard of care

Also known as: Lescol

Arm 1 Plus statin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• HIV positive
• Advanced liver disease
• Advanced cardiopulmonary disease
• Chronic renal failure

Sponsors & Collaborators

• Bader, Ted, M.D.: lead
• US Department of Veterans Affairs: collaborator

Study Sites (1)

Veterans Administration Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

Standard of Care; Fluvastatin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Ted F Bader, MD

  OUHSC and VAMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Liver Diseases, VA Medical Center

Study Record Dates

• First Submitted: June 15, 2007
• First Posted: June 18, 2007
• Study Start: June 1, 2007
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: August 21, 2012

Record last verified: 2012-08

Locations

US (1)