Phase 2
Completed N=25
This Trial Evaluates Safety, Pharmacokinetic Profile and Anti-viral Response of BI 207127 and BI 201335 for Patients With Chronic Hepatitis C
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT01528735 ↗
Enrolled (actual)
25
Serious AEs
2.1%
Results posted
Apr 2016
Primary outcomePrimary: Number of Patients With Drug-related Adverse Events — 12; 13 participants
Summary
The objective of this trial is to investigate tolerability, safety, pharmacokinetics and antiviral activity of BI 207127 NA in combination with BI 201335 NA and ribavirin for 8 weeks in Japanese treatment-naive patients with chronic GT-1 HCV infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Drug-related Adverse Events |
12; 13 | — |
| SECONDARY Percentage of Participants With Virological Response at Week 4 |
91.7; 92.3 | — |
| SECONDARY Percentage of Participants With Virological Response at Week 8 |
91.7; 100.0 | — |
| SECONDARY Maximum Measured Concentration (Cmax) of Deleobuvir |
12800; 18800; 30100; 50300; 18800; 41900 | — |
| SECONDARY Time From Last Dosing to the Maximum Concentration (Tmax) of Deleobuvir |
3.97; 5.03; 3.92; 3.94; 4.00; 3.98 | — |
| SECONDARY Area Under the Curve (AUC) of Deleobuvir |
77500; 118000; 216000; 404000; 111000; 326000 | — |
| SECONDARY Maximum Measured Concentration (Cmax) of Faldaprevir |
3380; 6440; 8530; 20400; 4750; 18700 | — |
| SECONDARY Time From Last Dosing to the Maximum Concentration (Tmax) of Faldaprevir |
3.97; 5.98; 3.92; 4.00; 3.92; 3.97 | — |
| SECONDARY Area Under the Curve (AUC) of Faldaprevir |
42900; 107000; 119000; 360000; 58700; 291000 | — |
| SECONDARY Maximum Measured Concentration (Cmax) of BI 208333 |
2600; 3630; 11100; 20800; 4630; 14600 | — |
| SECONDARY Time From Last Dosing to the Maximum Concentration (Tmax) of BI 208333 |
6.00; 7.80; 5.90; 3.99; 5.97; 5.98 | — |
| SECONDARY Area Under the Curve (AUC) of BI 208333 |
19900; 26000; 94200; 210000; 38400; 141000 | — |
| SECONDARY Maximum Measured Concentration (Cmax) of CD 6168 |
1640; 1920; 12200; 23400; 7150; 21000 | — |
| SECONDARY Time From Last Dosing to the Maximum Concentration (Tmax) of CD 6168 |
8.00; 9.81; 3.95; 3.94; 5.83; 4.10 | — |
| SECONDARY Area Under the Curve (AUC) of CD 6168 |
11200; 13200; 111000; 234000; 61400; 191000 | — |
| SECONDARY Maximum Measured Concentration (Cmax) of CD 6168-AG |
73.7; 106; 691; 2020; 455; 1780 | — |
| SECONDARY Time From Last Dosing to the Maximum Concentration (Tmax) of CD 6168-AG |
8.00; 9.93; 5.90; 4.96; 5.85; 6.08 | — |
| SECONDARY Area Under the Curve (AUC) of CD 6168-AG |
NA; NA; 6460; 20700; 4110; 17700 | — |
| SECONDARY Maximum Measured Concentration (Cmax) of RBV |
537; 601; 2560; 2740 | — |
| SECONDARY Time From Last Dosing to the Maximum Concentration (Tmax) of RBV |
2.00; 3.95; 2.08; 2.03 | — |
| SECONDARY Area Under the Curve (AUC) of RBV |
3410; 3730; 25700; 27600 | — |
| SECONDARY Cmax Accumulation Ratio (RA,Cmax,N) of Deleobuvir |
2.33; 2.68; 1.46; 2.20; 1.00; 1.00 | — |
| SECONDARY AUC Accumulation Ratio of Deleobuvir |
2.60; 3.43; 1.21; 2.74; 1.00; 1.00 | — |
| SECONDARY Mean Residence Time (MRTpo,ss) of Deleobuvir |
6.65; 12.6 | — |
| SECONDARY Apparent Clearance (CL/F,ss) of Deleobuvir |
8.25; 2.81 | — |
| SECONDARY Predose Measured Concentration of Deleobuvir |
10700; 23500; 3280; 16599 | — |
| SECONDARY Cmax Accumulation Ratio (RA,Cmax,N) of Faldaprevir |
2.72; 3.17; 1.51; 3.00 | — |
| SECONDARY AUC Accumulation Ratio of Faldaprevir |
2.88; 3.31; 1.28; 2.26 | — |
| SECONDARY Mean Residence Time (MRTpo,ss) of Faldaprevir |
— | — |
| SECONDARY Apparent Clearance (CL/F,ss) of Faldaprevir |
22.7; 6.87 | — |
| SECONDARY Predose Measured Concentration of Faldaprevir |
4250; 13800; 1540; 9980 | — |
| SECONDARY Cmax Accumulation Ratio of BI 208333 |
3.82; 5.73; 1.60; 3.99; 0.345; 0.349 | — |
| SECONDARY AUC Accumulation Ratio of BI 208333 |
4.16; 8.10; 1.48; 4.92; 0.345; 0.431 | — |
| SECONDARY Mean Residence Time (MRTpo,ss) of BI 208333 |
— | — |
| SECONDARY Predose Measured Concentration of BI 208333 |
7450; 16800; 1630; 10700 | — |
| SECONDARY Cmax Accumulation Ratio of CD 6168 |
8.34; 12.2; 4.90; 10.9; 0.380; 0.500 | — |
| SECONDARY AUC Accumulation Ratio of CD 6168 |
9.57; 17.0; 5.14; 14.2; 0.552; 0.600 | — |
| SECONDARY Mean Residence Time (MRTpo,ss) of CD 6168 |
— | — |
| SECONDARY Predose Measured Concentration of CD 6168 |
9610; 17600; 3190; 13100 | — |
| SECONDARY Cmax Accumulation Ratio of CD 6168-AG |
10.8; NA; 7.11; 17.2; 0.0242; 0.0424 | — |
| SECONDARY AUC Accumulation Ratio of CD 6168-AG |
16.7; NA; 8.06; NA; 0.0369; 0.0557 | — |
| SECONDARY Mean Residence Time (MRTpo,ss) of CD 6168-AG |
— | — |
| SECONDARY Predose Measured Concentration of CD 6168-AG |
566; 1630; 211; 1350 | — |
| SECONDARY AUC Accumulation Ratio of RBV |
8.03; 6.89 | — |
| SECONDARY Cmax Accumulation Ratio (RA,Cmax,57) of RBV |
5.05; 4.89 | — |
| SECONDARY Mean Residence Time (MRTpo,ss) of RBV |
— | — |
| SECONDARY Predose Measured Concentration of RBV |
1400; 1290; 2080; 2110 | — |
Eligibility Criteria
Inclusion criteria
- Chronic hepatitis C, diagnosed by positive anti-hepatitis C virus(HCV) antibodies and detected HCV ribonucleic acid(RNA) at screening in addition to:
- positive anti-HCV antibodies or detected HCV RNA at least 6 months prior to screening; or,
- liver biopsy consistent with chronic HCV infection.
- HCV infection of genotype 1 confirmed by genotypic testing at screening
- Therapy-naïve to interferon, pegylated interferon, ribavirin or any antiviral / immunomodulatory drug for acute or chronic HCV infection.
- Plasma HCV RNA = 100, 000 IU/mL at screening
Exclusion criteria
- Hepatitis C infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening
- Human immunodeficiency virus (HIV) co-infection
- Decompensated liver disease, or history of decompensated liver disease
- Body weight 125 kg at screening
- Hemoglobin 1.5xUpper Limit of Normal range(ULN) or creatinine clearance =50 mL/min at screening
Data sourced from ClinicalTrials.gov (NCT01528735). 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.