Phase 2
N=24
An Exploratory Study of Telaprevir in Treatment-Naive Participants With Chronic Genotype 4 Hepatitis C Virus Infection
Hepatitis C
Bottom Line
View on ClinicalTrials.gov: NCT00580801 ↗Enrolled (actual)
24
Serious AEs
4.2%
Results posted
Jul 2013
Primary outcome: Primary: Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Day 15 — 5.83; 6.16; 5.88; -0.77 log 10 IU/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Telaprevir (Drug); Pegylated-interferon-alfa-2a (Drug); Placebo (Drug); Ribavirin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tibotec BVBA
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Day 15 |
5.83; 6.16; 5.88; -0.77; -4.32; -1.58 | — |
| SECONDARY Percentage of Participants With Viral Response (Undetectable HCV RNA) |
0; 12.5; 0; 42.9; 37.5; 12.5 | — |
| SECONDARY Median Time to First Viral Response (Undetectable HCV RNA) |
93; 85.50; 128 | — |
| SECONDARY Number of Participants With Viral Breakthrough (Detectable HCV RNA) |
1; 0; 0; 3; 0; 0 | — |
| SECONDARY Percentage of Participants With Sustained Viral Response (SVR) |
75.0; 50.0; 62.5; 62.5; 50.0; 62.5 | — |
| SECONDARY Percentage of Participants With Relapse |
14.3; 33.3; 16.7 | — |
| SECONDARY Area Under the Serum Concentration-Time Curve (AUC) |
6702; 7467; 17120; 23320 | — |
| SECONDARY Maximum Serum Concentration (Cmax) of Telaprevir |
1598; 1709; 2733; 3669 | — |
| SECONDARY Pre-Dose Serum Concentration (C[0h]) of Telaprevir |
1873; 2806 | — |
| SECONDARY Minimum Serum Concentration (Cmin) of Telaprevir on Day 15 |
1639; 2100 | — |
| SECONDARY Time to Reach the Maximum Serum Concentration (Tmax) of Telaprevir |
4.02; 4.00; 2.92; 3.00 | — |
| SECONDARY Average Steady-State Serum Concentration (Css,av) of Telaprevir |
2141; 2896 | — |
Summary
The purpose of this study is to evaluate the activity and safety of telaprevir on Hepatitis C Virus (HCV) Genotype 4, alone or in combination with standard therapy, that is, pegylated-interferon-alfa-2a and ribavirin in treatment-naive (never been treated before with antiretroviral therapy) participants.
Eligibility Criteria
Inclusion Criteria: - Participant has chronic Genotype 4 Hepatitis C infection
- Plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level greater than 10,000 International unit per milliliter (IU/mL) at Screening
- Participant never received treatment for HCV
- Participant was to be in good health (besides HCV infection), in the opinion of the Investigator, judged on the basis of medical history and physical examination (including vital signs and screening electrocardiogram [ECG]), with any chronic medical conditions under stable medical control
- Participant had to be willing to refrain from the concomitant use of any medications or substances Exclusion Criteria: - Participants with history or evidence of cirrhosis or history of suspicion of alcohol, barbiturate, or amphetamine recreational or narcotic drug use, which in the Investigator's opinion would compromise the participant's safety and/or compliance with study procedures
- Participant has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection
- Female participants who are pregnant, or planning to become pregnant, or breastfeeding, and partners of female participants who are pregnant or breastfeeding
- Participant has hypersensitivity to tartrazine
- Participant had participated in any clinical trial for an investigational drug within 90 days before drug administration or participated in more than 2 drug studies in the last 12 months
Data sourced from ClinicalTrials.gov (NCT00580801). 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.