Phase 2
Completed N=160
Short Term Treatment With BI 201335, Peginterferon-alpha 2a and Ribavirin in Hepatitis c Virus Genotype-1 Treatment-naïve Patients (SILEN-C3)
Source: ClinicalTrials.gov NCT00984620 ↗Enrolled (actual)
160
Serious AEs
3.8%
Results posted
Sep 2015
Primary outcomePrimary: Virological Response at Week 28 (W28VR) — 61; 60 participants — p=0.855
Summary
To compare the antiviral efficacy and safety of a 12-week with a 24-week treatment of BI 201335 at a dose of 120 mg once daily, with a 24-week background of pegylated interferon-alpha 2a (PegIFN) plus ribavirin (RBV), in treatment-naïve patients infected with hepatitis C virus (HCV) genotype 1
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Virological Response at Week 28 (W28VR) |
61; 60 | 0.855 |
| SECONDARY Rapid Virological Response at Week 4 (RVR) |
48; 56 | 0.229 |
| SECONDARY Virological Response at Week 24 (W24VR) |
59; 63 | 0.417 |
| SECONDARY Virological Response at Week 36 (W36VR) |
55; 58 | 0.676 |
| SECONDARY End of Treatment Response (ETR) |
65; 67 | 0.588 |
| SECONDARY Sustained Virological Response (SVR24) at 24 Weeks After Completion of All Therapy |
54; 58 | 0.512 |
| SECONDARY Viral Load (HCV RNA) at All Visits During Treatment and Follow-up |
-4.724; -4.866; -4.993; -5.081; -5.128; -5.088 | — |
| SECONDARY Time to Reach a Plasma HCV RNA Level BLD While on Treatment |
4.1; 4.1 | 0.1397 |
| SECONDARY Laboratory Test Abnormalities and Study Medication Tolerabilities |
9; 8; 30; 21; 0; 1 | — |
| SECONDARY Number of Participants With Clinically Relevant Abnormalities Vital Signs, and Physical Examination |
0; 0 | — |
| SECONDARY Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1) |
0.0; -0.1; -0.3; -0.4; -0.8; -0.8 | — |
| SECONDARY Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2) |
-0.9; -1.3; -4.3; -4.7; -8.0; -7.9 | — |
| SECONDARY Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3) |
3; 2; -35; -35; -35; -39 | — |
| SECONDARY Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) |
0; -5; -24; -29; -25; -29 | — |
| SECONDARY Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6) |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
Eligibility Criteria
Inclusion criteria
- Chronic hepatitis C infection of genotype 1
- Therapy-naïve to interferon, pegylated interferon, and ribavirin
- HCV viral load > 100.000 IU/ml at screening
- Liver biopsy or fibroscan within two years prior to screening that provides evidence of any degree of fibrosis or cirrhosis
- Normal retinal finding on fundoscopy within 6 months prior to Day 1
- Age 18 to 70 years
Exclusion criteria
- HCV of mixed genotype (1/2, 1/3, and 1/4) .
- Patients who have been previously treated with at least one dose of any protease inhibitor
- Evidence of liver disease due to causes other than chronic HCV infection
- Positive for HIV-1 or HIV-2 antibodies
- Hepatitis B virus (HBV) infection
- Decompensated liver disease, or history of decompensated liver disease
- Active malignancy or history of malignancy within the last 5 years
- History of alcohol or drug abuse (except cannabis) within the past 12 months.
- Body Mass Index 35 kg/m2.
- Usage of any investigational drugs within 30 days prior to enrolment
- Alpha fetoprotein value >100ng/mL at screening;
- Total bilirubin > 1.5 x ULN with ratio of direct/indirect > 1.
- ALT or AST level > 10 x ULN
Data sourced from ClinicalTrials.gov (NCT00984620). 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.