Phase 2
Completed N=49
A Phase 2a Study to Evaluate Viral Kinetics and Safety of Telaprevir in Participants With Genotype 2 or 3 Hepatitis C Infection
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT00561015 ↗
Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Jun 2013
Primary outcomePrimary: Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Day 15 — 6.61; 6.21; 6.15; 6.65 log10 IU/ml
Summary
The purpose of this study is to assess the effect of telaprevir on early hepatitis (inflammation of the liver) C virus (HCV) viral kinetics in treatment-naive participants who are chronically (lasting a long time) infected with genotype 2 or 3 HCV.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Day 15 |
6.61; 6.21; 6.15; 6.65; 6.79; 6.92 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) for Telaprevir on Day 1 |
1886; 2462; 1497; 1588 | — |
| PRIMARY Time to Reach Maximum Plasma Concentration (Tmax) for Telaprevir on Day 1 |
3.0; 4.0; 4.0; 4.0 | — |
| PRIMARY Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 1 |
7980; 11248; 6938; 6979 | — |
| SECONDARY Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 15 |
20144; 26588; 18480; 20895 | — |
| SECONDARY Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Week 24 and Week 26 |
-5.91; -5.51; -5.45; -5.71; -5.50; -6.22 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) for Telaprevir on Day 15 |
3261; 4318; 2898; 3358 | — |
| SECONDARY Minimum Plasma Concentration (Cmin) for Telaprevir on Day 15 |
1605; 2164; 1800; 2002 | — |
| SECONDARY Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) |
0.00; 60.0; 0.00; 0.00; 11.1; 22.2 | — |
| SECONDARY Median Time to Virological Response (HCV RNA Level < 10 IU/ml) |
31.0; 12.0; 43.0; 99.0; 43.0; 29.0 | — |
| SECONDARY Percentage of Participants With Viral Breakthrough |
11.1; 0.0; 0.0; 37.5; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants Who Demonstrated Virological Relapse |
12.5; 0.0; 0.0; 33.3; 33.3; 22.2 | — |
| SECONDARY Percentage of Participants Who Achieved Sustained Virological Response (SVR) |
66.7; 100; 88.9; 50.0; 66.7; 44.4 | — |
Eligibility Criteria
Inclusion Criteria
- Participants chronically infected with genotype 2 or 3 hepatitis C virus (HCV) with amount of virus in the blood greater than 10,000 international units per milliliter (IU/ml)
- Participants who were never treated for hepatitis C virus infection
- Participants without any significant lab abnormalities
- Participants who agree to the use of two effective methods of contraception
- Participant who were judged to be in good health
Exclusion Criteria
- Participants who had contraindications for starting anti-HCV therapy
- Participants who had 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 or hepatocellular carcinoma (type of cancer)
- Participant infected with human immunodeficiency virus (a life-threatening infection that you can get from an infected person's blood or from having sex with an infected person) or hepatitis B virus
- Females who are pregnant (carrying an unborn baby), planning to be pregnant or breastfeeding
- Participants who have hypersensitivity to tartrazine
Data sourced from ClinicalTrials.gov (NCT00561015). 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.