Phase 2
Completed N=22
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 201335 as Softgel Capsule in Naive Hepatitis C Virus (HCV) Patients
Hepatitis C · Pharmacokinetics
Source: ClinicalTrials.gov NCT00947349 ↗
Enrolled (actual)
22
Serious AEs
4.7%
Results posted
Jul 2015
Primary outcomePrimary: Number of Participants With Investigator Defined Drug-related Adverse Events in Triple Combination Therapy — 3; 6; 6; 5 participants
Summary
The current Standard of Care (SOC) for chronic HCV infection, which is pegylated interferon-alfa as combination therapy with ribavirin for 24-48 weeks of treatment, is effective in only part of the patients and is often associated with severe adverse effects leading to discontinuation of treatment and dose modifications.
A number of compounds with direct activity are currently under clinical development, incl. BI 201335. BI 201335 works by preventing the Hepatitis C virus from replicating by binding to the HCV protease (enzyme). The main purpose of this clinical trial with BI 201335 is to see how well BI 201335 works and how safe BI 201335 is to use daily in combination with PegIFN and RBV in HCV infected patients
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Investigator Defined Drug-related Adverse Events in Triple Combination Therapy |
3; 6; 6; 5 | — |
| PRIMARY Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Triple Combination Therapy |
2; 2; 3; 4; 3; 3 | — |
| PRIMARY Assessment of Tolerability in Triple Combination Therapy |
3; 5; 5; 6; 0; 1 | — |
| SECONDARY Week 2 Virological Response (W2VR) |
0; 5; 6; 3 | — |
| SECONDARY Week 4 Virological Response (W4VR) |
0; 6; 6; 5 | — |
| SECONDARY Rapid Virological Response (RVR) |
0; 5; 6; 4 | — |
| SECONDARY Change From Baseline in HCV Viral Load |
-3.30; -5.88; -5.95; -5.53 | — |
| SECONDARY Day 28 Virologic Response |
3; 6; 6; 6 | — |
| SECONDARY Early Virological Response (EVR) |
4; 5; 6; 6 | — |
| SECONDARY Complete Early Virological Response (cEVR) |
3; 5; 5; 6 | — |
| SECONDARY End of Treatment Response (ETR) |
3; 5; 4; 4 | — |
| SECONDARY Sustained Virologic Response (SVR) |
2; 4; 5; 3 | — |
| SECONDARY Number of Participants With Investigator Defined Drug-related Adverse Events in Standard of Care (SOC) With PegIFN α-2a and RBV |
3; 5; 4; 5 | — |
| SECONDARY Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Standard of Care (SOC) With PegIFN α-2a and RBV |
1; 3; 5; 4; 4; 2 | — |
| SECONDARY Assessment of Tolerability in Standard of Care (SOC) With PegIFN α -2a and RBV |
2; 4; 1; 3; 2; 0 | — |
| SECONDARY AUCτ,1 for BI 201335 ZW |
68900; 171000; 233000 | — |
| SECONDARY Cmax of BI 201335 ZW |
5500; 12600; 15000 | — |
| SECONDARY AUCτ,ss of BI 201335 ZW |
70800; 361000; 499000 | — |
| SECONDARY Cmax,ss of BI 201335 ZW |
5880; 24500; 29100 | — |
| SECONDARY AUCτ,1 for Ribavirin (RBV) |
5160; 4660; 4620; 3500 | — |
| SECONDARY Cmax of RBV |
1130; 761; 724; 509 | — |
| SECONDARY AUCτ,ss of RBV |
27500; 25200; 22400; 20000 | — |
| SECONDARY Cmax,ss of RBV |
3060; 2710; 2280; 2130 | — |
| SECONDARY Tmax for BI 201335 ZW |
4.98; 5.50; 7.97 | — |
| SECONDARY Tmax for RBV |
1.94; 3.98; 3.92; 4.98 | — |
| SECONDARY Tmax, ss for BI 201335 ZW |
3.83; 2.99; 3.49 | — |
| SECONDARY Tmax, ss for RBV |
2.42; 2.92; 2.90; 3.92 | — |
| SECONDARY t1/2,ss for BI 201335 ZW |
29.3; 21.2; 23.0 | — |
| SECONDARY Cmin,ss for BI 201335 ZW |
1550; 10200; 16000 | — |
| SECONDARY Cmin,ss for RBV |
1980; 1730; 1590; 1400 | — |
| SECONDARY Cavg for BI 201335 ZW |
2950; 15000; 20800 | — |
| SECONDARY Cavg for RBV |
2290; 2100; 1860; 1670 | — |
| SECONDARY CL/F,ss for BI 201335 ZW |
28.2; 11.1; 8.01 | — |
Eligibility Criteria
Inclusion criteria
- chronic HCV genotype-1;
- high viral load
Exclusion criteria
- Mixed genotype (1/2, 1/3, or 1/4), diagnosed by genotypic testing at screening
- Previous treatment with protease inhibitor
Data sourced from ClinicalTrials.gov (NCT00947349). 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.