Phase 1
Completed N=57
4 Week Combination of BI 207127 NA With Peg-IFN and Ribavirin in Chronic HCV Patients
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT00905632 ↗
Enrolled (actual)
57
Serious AEs
5.3%
Results posted
Apr 2016
Primary outcomePrimary: Number of Participants With Virologic Response Defined as >= 3 Log Drop in Viral Load From Baseline at Day 28 With no Evidence of Virologic Rebound During These 28 Days. Virologic Rebound is Defined as >= 1 Log Increase in Viral Load From Nadir. — 1; 5; 7; 6 Participants
Summary
The main purpose of this clinical trial with BI 207127 is to see the effect of 4 week combination of BI 207127 with Peginterferon alfa (Peg-IFN) and Ribavirin (RBV) on hepatitis C virus (HCV) virus load and how safe BI 207127 is in this combination in HCV infected patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Virologic Response Defined as >= 3 Log Drop in Viral Load From Baseline at Day 28 With no Evidence of Virologic Rebound During These 28 Days. Virologic Rebound is Defined as >= 1 Log Increase in Viral Load From Nadir. |
1; 5; 7; 6; 4; 5 | — |
| SECONDARY Viral Load (Log10) at Each Visit up to Day 28, Change From Baseline |
-0.04; -0.09; -0.01; -0.06; 0.02; 0.04 | — |
| SECONDARY Viral Load at Each Visit up to Day 28 |
3540000; 3260000; 8480000; 3440000; 3620000; 3560000 | — |
| SECONDARY Number of Participants With Virologic Response at Day 28 |
0; 4; 6; 6; 1; 3 | — |
| SECONDARY Number of Participants With Rapid Virological Response |
0; 3; 4; 3; 0; 2 | — |
| SECONDARY Number of Participants With Early Virological Response |
7; 5; 7; 6; 6; 6 | — |
| SECONDARY Number of Participants With End of Treatment Response |
4; 3; 6; 6; 4; 3 | — |
| SECONDARY Number of Participants With Sustained Virological Response |
2; 2; 5; 6; 0; 0 | — |
| SECONDARY Plasma Concentration Time Profiles of BI 207127 |
111; 103; 230; NA; 422; NA | — |
| SECONDARY Plasma Concentration Time Profiles of CD 6168 |
NA; NA; NA; NA; NA; NA | — |
| SECONDARY Cmax of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State) |
2420; 3490; 7440; 3590; 5910; 7640 | — |
| SECONDARY Tmax of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State) |
2.96; 3.87; 3.91; 3.11; 3.19; 4.10 | — |
| SECONDARY AUC0-6 of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State) |
8840; 13500; 23700; 13000; 21900; NA | — |
| SECONDARY Cpre Pharmacokinetic Parameter of BI 207127 and CD 6168 |
NA; NA; NA; NA; NA; NA | — |
| SECONDARY C6,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose |
1520; 4030; 5820; 1380; 2810; 5910 | — |
| SECONDARY AUC0-infinity,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose |
20500; 38600; 62300; 16900; 31500; 71300 | — |
| SECONDARY λz Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose |
0.162; 0.182; 0.170; 0.226; 0.163; 0.174 | — |
| SECONDARY t1/2,ss and MRTpo,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose |
4.28; 3.81; 4.09; 3.06; 4.26; 3.99 | — |
| SECONDARY RA,Cmax Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose |
1.35; 1.72; 1.64; 0.965; 1.02; 1.44 | — |
| SECONDARY Number of Participants With Clinical Relevant Abnormalities for Vital Signs, Body Temperature, Physical Examination, Blood Chemistry, Haematology, Coagulation, Urinalysis and ECG |
0; 0; 1; 3; 0; 1 | — |
| SECONDARY Number of Participants With Discontinuations Due to AEs |
0; 0; 1; 4 | — |
Eligibility Criteria
Inclusion criteria
- HCV genotype 1
- HCV viral load >100,000 IU/mL
- histology or fibroscan to rule out cirrhosis
- Absence of retinopathy
- treatment naive patients and treatment experienced patients
- Age 18 - 70 years
- Male OR female with documented hysterectomy OR postmenopausal
Exclusion criteria
- Fertile males not willing to use an adequate form of contraception
- Pretreatment with any HCV-polymerase inhibitor
- Any concurrent disease if clinically significant based on the investigator's medical assessment
- Current alcohol or drug abuse, or history of the same
- Positive test for HIV or HBs
- History of malignancy
- Planned or concurrent usage of any other pharmacological therapy including any antiviral therapy or vaccination
- Usage of any investigational drug within thirty (30) days prior to enrolment or 5 halflives, whichever is longer
- Any clinically significant laboratory abnormalities based on the investigator's medical assessment at screening
- Patients treated with any interferon (approved or investigational) or Peg-IFN and/or Ribavirin within 3 months prior to screening
- Known hypersensitivity to drugs or excipients; Further exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT00905632). 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.