4 Week Combination of BI 207127 NA With Peg-IFN and Ribavirin in Chronic HCV Patients

Phase 1

Completed

• Conditions: Hepatitis C, Chronic
• Interventions: Drug: BI 207127 low dose + SOC; Drug: BI 207127 middle dose +SOC; Drug: BI 207127 high dose+SOC; Drug: Placebo + SOC

• Registration Number: NCT00905632
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-19
• Study First Submitted QC: 2009-05-19
• Study First Posted: 2009-05-20
• Primary Completion: 2011-03
• Results First Submitted: 2016-01-21
• Status Verified: 2016-03
• Results First Submitted QC: 2016-03-17
• Last Update Submitted: 2016-03-17
• Results First Posted: 2016-04-19
• Last Update Posted: 2016-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 207127 low dose + SOC	BI 207127 low dose + SOC	BI 207127 low dose tid + SOC
BI 207127 middle dose +SOC	BI 207127 middle dose +SOC	BI 207127 middle dose tid + SOC
BI 207127 high dose+SOC	BI 207127 high dose+SOC	BI 207127 high dose tid +SOC
Placebo + SOC	Placebo + SOC	Placebo tid +SOC

Primary Outcome Measures

Name	Time	Method
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.	Baseline and 4 weeks	The primary efficacy endpoint is the 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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Rapid Virological Response	4 weeks	Number of participants with rapid virological response - defined as serum Hepatitis C virus (HCV) RNA level below the limit of detection (BLD) of the Roche COBAS Taqman HCV/High Pure System (HPS) for extraction assay (10 IU/mL) on Day 28.
Number of Participants With End of Treatment Response	Week 12	Number of participants with end of treatment response (ETR) - defined as serum HCV RNA level below the limit of detection (BLD) of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at end of treatment (including 5-day washout). Number of responders\* - Response = Viral load below the limit of detection at end of all treatment.
AUC0-6 of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State)	30min, 1 hour (h), 2h, 3h, 4h and 5h 55min after drug administration on day 1: 30min, 1h, 2h, 3h, 4h and 6h after admin on day 28	Area under the concentration-time curve of the analyte in plasma (AUC) after first dose on day 1 (AUC0-6) and after last dose on day 28 (AUC0-6,ss) of BI 207127 and CD 6168
Cpre Pharmacokinetic Parameter of BI 207127 and CD 6168	5 minutes before drug administration on days 1, 2, 4, 8, 15, 22 and 27	Cpre,N \[ng/mL\] - Predose concentration of the analyte in plasma immediately before administration of the Nth dose after N-1 doses were administered for BI 207127 and CD 6168. Descriptive statistics were calculated only if at least 2/3 plasma concentrations were available. All values for Cpre,1 were not available, therefore no results are presented below.
Viral Load (Log10) at Each Visit up to Day 28, Change From Baseline	Baseline and days 1, 2, 4, 8, 15, 22 and 28	Reductions of viral load (Log10) at each visit up to day 28, change from baseline. Change from baseline was calculated as the value at baseline minus the value at each later visit.; A negative value represents an increase in viral load, a positive value represents a decrease in viral load.
Cmax of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State)	5 min before drug admin and 30min, 1 hour (h), 2h, 3h, 4h, 5h 55min, 8h, 10h, 11h 55min and 15h after drug administration on day 1: 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28	Maximum measured concentration of the analyte in plasma (Cmax) after first dose on day 1 (Cmax) and after last dose (steady state) on day 28 (Cmax,ss) of BI 207127 and CD 6168
AUC0-infinity,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose	5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28	Area under the concentration time curve of the analyte in plasma over the time interval of 0 to infinity at steady state (AUC0-infinity,ss): Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State (SS) After the Last Dose
Viral Load at Each Visit up to Day 28	Baseline and days 8, 15, 22 and 28	Viral load (VL) (original values) at each visit up to day 28.
Number of Participants With Early Virological Response	Baseline and week 12	Number of participants with early virological response (EVR) defined as at least 2log10 reduction in HCV Ribonucleic acid (RNA) from baseline at Week 12. Number of responders\* - Response = At least a 2 log10 reduction in viral load from baseline at Week 12 (Day 84)
Number of Participants With Sustained Virological Response	Until end of treatment, up to 570 days	Number of participants with sustained virological response. Sustained virological response was defined as serum HCV RNA below the limit of detection (\<10 IU/mL) at least 85 days after stopping standard care (SOC).
λz Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose	5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28	Terminal rate constant in plasma (λz): Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose
Number of Participants With Virologic Response at Day 28	day 28	Number of participants with virologic response at day 28, defined as achieving viral load below the limit of quantification (BLQ), \<10 IU/mL, at day 28
Plasma Concentration Time Profiles of BI 207127	0.5 hours (h), 3h, 8h, 15h, 23.917h, 503.917h, 649h, 652h, 656h and 672h after drug administration	Plasma concentration time profiles of BI 207127
Plasma Concentration Time Profiles of CD 6168	0.5 hours (h), 3h, 8h, 15h, 23.917h, 503.917h, 649h, 652h, 656h and 672h after drug administration	Plasma concentration time profiles of CD 6168
C6,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose	654 hours after drug administration on day 28	C6,ss Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose. C6,ss is the concentration 6 hours after dosing at steady-state (reported as 654 h).
Tmax of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State)	5 min before drug admin and 30min, 1 hour (h), 2h, 3h, 4h, 5h 55min, 8h, 10h, 11h 55min and 15h after drug administration on day 1: 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28	tmax \[h\] Time from (last) dosing to the maximum measured concentration of the analyte in plasma after first dose on day 1 and after last dose on day 28 (steady state).
t1/2,ss and MRTpo,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose	5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28	Terminal half-life of the analyte in plasma at steady state (t1/2,ss) and mean residence time of the analyte in the body at steady state after oral administration (MRTpo,ss): Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose
RA,Cmax Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose	5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28	Accumulation ratio of maximum measured concentration of the analyte in plasma (RA,Cmax): Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose. Ratio was calculated as Cmax,ss divided by Cmax.
Number of Participants With Clinical Relevant Abnormalities for Vital Signs, Body Temperature, Physical Examination, Blood Chemistry, Haematology, Coagulation, Urinalysis and ECG	From the start of the study to Day 30 (2 days after last dose)	Number of participants with clinically relevant abnormalities for vital signs, blood chemistry, body temperature, physical examination, haematology, coagulation, urinalysis and electrocardiography (ECG). New abnormal findings or worsening of baseline conditions were reported as adverse events.
Number of Participants With Discontinuations Due to AEs	4 weeks	Number of participants with adverse events (AEs) leading to discontinuation of trial drug

Trial Locations

Locations (18)

1241.7.3307A CHU de Grenoble; 🇫🇷 Grenoble cédex 9, France

1241.7.3303A Hôpital Claude Huriez; 🇫🇷 Lille, France

1241.7.49011 Boehringer Ingelheim Investigational Site; 🇩🇪 Freiburg, Germany

1241.7.41003 Boehringer Ingelheim Investigational Site; 🇨🇭 Basel, Switzerland

1241.7.49010 Boehringer Ingelheim Investigational Site; 🇩🇪 Aachen, Germany

1241.7.49012 Boehringer Ingelheim Investigational Site; 🇩🇪 Berlin, Germany

1241.7.3302A Hopital de l'Hotel Dieu; 🇫🇷 Lyon cedex 02, France

1241.7.3301A Hôpital Saint Eloi; 🇫🇷 Montpellier, France

1241.7.3305A HOP Archet 2; 🇫🇷 Nice Cedex 3, France

1241.7.3304A HOP de Brabois; 🇫🇷 Vandoeuvre, France

1241.7.3306A Hôpital Haut-Lévêque; 🇫🇷 Pessac Cedex, France

1241.7.49009 Boehringer Ingelheim Investigational Site; 🇩🇪 Regensburg, Germany

1241.7.49004 Boehringer Ingelheim Investigational Site; 🇩🇪 Essen, Germany

1241.7.49001 Boehringer Ingelheim Investigational Site; 🇩🇪 Hamburg, Germany

1241.7.49013 Boehringer Ingelheim Investigational Site; 🇩🇪 Mainz, Germany

1241.7.49002 Boehringer Ingelheim Investigational Site; 🇩🇪 Ulm, Germany

1241.7.41001 Boehringer Ingelheim Investigational Site; 🇨🇭 St. Gallen, Switzerland

1241.7.41004 Boehringer Ingelheim Investigational Site; 🇨🇭 Lugano, Switzerland