Fluvastatin, Rosuvastatin Added to Pegylated Interferon and Ribavirin

Chronic Hepatitis C Clinical Trial

Official title:

A Randomized Controlled Trial of Adding Fluvastatin to Standard Medical Treatment (SMT) and a Pilot Trial of Rosuvastatin and Other Statins With SMT, for Patients Infected With Chronic Hepatitis C Who Are Naive to Therapy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00487318
• Other study ID #: 13358
• Status: Completed
• Phase: Phase 2
• First received: June 15, 2007
• Last updated: August 20, 2012
• Start date: June 2007
• Est. completion date: October 2010

Study information

• Verified date: August 2012
• Source: Bader, Ted, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• standard of care
peginterferon/RBV
• fluvastatin
Add fluvastatin at 20-40 mg/day to standard of care

Locations

Country	Name	City	State
United States	Veterans Administration Medical Center	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Bader, Ted, M.D.	VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained Viral response		72 weeks	Yes
Secondary	Viral load at 4, 12 and 24 weeks		24 weeks	Yes