Phase 2
Completed N=161
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
Chronic Hepatitis C
Source: ClinicalTrials.gov NCT00528528 ↗
Enrolled (actual)
161
Serious AEs
6.8%
Results posted
May 2013
Primary outcomePrimary: Percentage of Participants With Virologic Response at Week 12 — 92.5; 88.1; 92.5; 87.2 Percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Virologic Response at Week 12 |
92.5; 88.1; 92.5; 87.2 | — |
| SECONDARY Time to First Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level |
22; 22.5; 22; 29 | — |
| SECONDARY Number of Participants With Viral Breakthrough at End of Treatment (EOT) |
1; 6; 3; 4 | — |
| SECONDARY Percentage of Participants With Partial Response |
5; 0; 2.5; 5.1 | — |
| SECONDARY Change From Baseline in Log 10-Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values at Week 12 |
6.4; 6.5; 6.4; 6.5; -5.2; -5.4 | — |
| SECONDARY Change From Baseline in Log 10-Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values at End of Treatment (EOT) |
-5.5; -5.2; -5.4; -5.3 | — |
| SECONDARY Percentage of Participants With Sustained Viral Response 24 Weeks After End of Treatment (SVR24) |
85.0; 81.0; 82.5; 82.1 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00528528). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.