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OpenTrials
Completed

NCT Number: NCT00487318

Fluvastatin, Rosuvastatin Added to Pegylated Interferon and Ribavirin

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Veterans Administration Medical Center

Oklahoma City, Oklahoma, 73104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard of care

Drug

peginterferon/RBV

Fluvastatin

Drug

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

Other names: Lescol

Primary outcomes

  1. Sustained Viral response

    Time frame: 72 weeks

Secondary outcomes

  1. Viral load at 4, 12 and 24 weeks

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Bader, Ted, M.D.

Indiv

Collaborators

  • US Department of Veterans Affairs

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jun 18, 2007
Registry last updated
Aug 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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