Phase 3
Completed N=1,088
A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 Hepatitis C Virus (HCV)
Source: ClinicalTrials.gov NCT00627926 ↗Enrolled (actual)
1,088
Serious AEs
8.1%
Results posted
Jul 2011
Primary outcomePrimary: Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment — 158; 250; 271; 166 participants
Summary
A Phase 3 study to evaluate the efficacy and safety of two dosing regimens of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment |
158; 250; 271; 166; 261; 285 | — |
| SECONDARY Number of Subjects With Undetectable HCV RNA at Week 72 |
158; 243; 265 | — |
| SECONDARY Number of Subjects Achieving Rapid Viral Response (RVR), Demonstrated by Achieving Undetectable HCV RNA 4 Weeks After Starting Study Treatment |
34; 242; 246 | — |
| SECONDARY Number of Subjects Achieving Extended Rapid Viral Response (eRVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12 |
29; 207; 212 | — |
| SECONDARY Number of Subjects With Undetectable HCV RNA at Week 12 |
146; 277; 283 | — |
| SECONDARY Number of Subjects With Undetectable HCV RNA at End of Treatment (EOT) |
229; 295; 314 | — |
| SECONDARY Number of Subjects With Undetectable HCV RNA 12 Weeks After Last Planned Dose of Study Treatment |
161; 255; 275 | — |
| SECONDARY Number of Subjects With Undetectable HCV RNA 24 Weeks After Last Actual Dose of Study Treatment |
158; 251; 274 | — |
| SECONDARY Number of Subjects With Viral Relapse Planned and Viral Relapse Actual |
64; 28; 27; 64; 28; 25 | — |
| SECONDARY Biochemical Response: Number of Subjects With Grade 3 and 4 Shifts From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Levels |
12; 5; 6; 0; 1; 0 | — |
| SECONDARY Noninvasive Markers of Fibrosis: Number of Subjects With Improvement in FibroTest Analysis |
35; 59; 84; 31; 12; 12 | — |
| SECONDARY Fatigue Severity Scale (FSS) Total Score |
3.0; 3.2; 3.0; 4.1; 4.4; 4.5 | — |
| SECONDARY Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
354; 362; 361; 24; 31; 33 | — |
Eligibility Criteria
Inclusion Criteria
- Has not received any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C
- Male and female subjects, 18 to 70 years of age, inclusive
- Genotype 1, chronic hepatitis C with detectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
- Screening laboratory values, tests, and physical exam within acceptable ranges
- Able and willing to follow contraception requirements
- Able to read and understand, and willing to sign the informed consent form and abide by the study restrictions
Exclusion Criteria
- Subject has any contraindications to Pegasys® or Copegus® therapy
- Evidence of hepatic decompensation in cirrhotic subjects
- History of organ transplant
- History of, or any current medical condition which could impact the safety of the subject in participation in the study
Data sourced from ClinicalTrials.gov (NCT00627926). 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.