An Open-Label Study of Telaprevir Administered Every 12 or 8 Hours in Combination With One of Two Pegylated Interferons and Ribavirin in Treatment-Naive Genotype 1 Chronic Hepatitis C Participants

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to explore the efficacy, safety, tolerability, pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time), and pharmacokinetic-pharmacodynamic relationships of telaprevir administered in two different doses in combination with two standard therapies commercially available for chronic (lasting a long time) genotype 1 Hepatitis (inflammation of the liver) C virus (HCV) infection.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tibotec BVBA
• Treatments: Interferon alpha-2; Interferon-alfa-1b; Interferon-alpha; Interferons; Peginterferon alfa-2a; Peginterferon alfa-2b; Pharmaceutical Solutions; Ribavirin

Criteria

Inclusion Criteria:

• Chronic genotype 1 Hepatitis (inflammation of the liver) C infection

• Never been treated for Hepatitis C Viral (HCV) infection

• No clinically significant lab abnormalities

• Amount of HCV Ribonucleic acid (RNA) in the blood more than 10,000 international units/milliliter (IU/mL) at entry

• Liver biopsy or "Fibroscan" test performed during screening or in the past 3 years

Exclusion Criteria:

• Contra-indications for starting anti-HCV therapy

• History or evidence of liver cirrhosis (serious liver disorder in which connective tissue replaces normal liver tissue, and liver failure often occurs) or decompensated liver disease

• Any evidence of significant liver disease in addition to Hepatitis C

• Infected with Human Immunodeficiency Virus (a life-threatening infection which you can get from an infected person's blood or from having sex with an infected person) or Hepatitis B

• Women who are pregnant (carrying an unborn baby), planning to be pregnant or breastfeeding or the partner of a woman who is pregnant or breastfeeding