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Clinical Trials/NCT01528735
NCT01528735
Completed
Phase 2

An Open-label, Ascending Dose, Phase II Study to Evaluate Tolerability, Safety, Antiviral Activity, and Pharmacokinetics of BI 207127 NA in Combination With BI 201335 NA and Ribavirin for 8 Weeks in Treatment-naïve Japanese Patients With Genotype 1chronic Hepatitis C Virus Infection

Boehringer Ingelheim5 sites in 1 country25 target enrollmentFebruary 2012
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ConditionsHepatitis C, Chronic
InterventionspeginterferonRibavirinBI 207127 NABI 201335 NA
DrugsBI 207127 NApeginterferonRibavirinBI 201335 NA

Overview

Phase
Phase 2
Intervention
peginterferon
Conditions
Hepatitis C, Chronic
Sponsor
Boehringer Ingelheim
Enrollment
25
Locations
5
Primary Endpoint
Number of Patients With Drug-related Adverse Events
Status
Completed
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
February 2012
End Date
August 2013
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

BI 207127 NA, BI 201335 NA(high dose), R

Patients receive BI 207127 NA,BI 201335 NA(high dose) and RBV for 8 wks followed by BI 201335 NA,PegIFN/RBV for 24 wks

Intervention: peginterferon

BI 207127 NA, BI 201335 NA(high dose), R

Patients receive BI 207127 NA,BI 201335 NA(high dose) and RBV for 8 wks followed by BI 201335 NA,PegIFN/RBV for 24 wks

Intervention: Ribavirin

BI 207127 NA, BI 201335 NA(high dose), R

Patients receive BI 207127 NA,BI 201335 NA(high dose) and RBV for 8 wks followed by BI 201335 NA,PegIFN/RBV for 24 wks

Intervention: BI 207127 NA

BI 207127 NA, BI 201335 NA(high dose), R

Patients receive BI 207127 NA,BI 201335 NA(high dose) and RBV for 8 wks followed by BI 201335 NA,PegIFN/RBV for 24 wks

Intervention: BI 201335 NA

BI 207127 NA,BI 201335 NA(low dose),RBV

Patients receive BI 207127 NA,BI 201335 NA(low dose) and RBV for 8 wks followed by BI 201335 NA,PegIFN/RBV for 24 wks

Intervention: BI 207127 NA

BI 207127 NA,BI 201335 NA(low dose),RBV

Patients receive BI 207127 NA,BI 201335 NA(low dose) and RBV for 8 wks followed by BI 201335 NA,PegIFN/RBV for 24 wks

Intervention: Ribavirin

BI 207127 NA,BI 201335 NA(low dose),RBV

Patients receive BI 207127 NA,BI 201335 NA(low dose) and RBV for 8 wks followed by BI 201335 NA,PegIFN/RBV for 24 wks

Intervention: BI 201335 NA

BI 207127 NA,BI 201335 NA(low dose),RBV

Patients receive BI 207127 NA,BI 201335 NA(low dose) and RBV for 8 wks followed by BI 201335 NA,PegIFN/RBV for 24 wks

Intervention: peginterferon

Outcomes

Primary Outcomes

Number of Patients With Drug-related Adverse Events

Time Frame: From first dose of study medication until 30 days after last dose of study medication, up to 199 days

Number of patients with investigator defined drug-related Adverse Events

Secondary Outcomes

  • Percentage of Participants With Virological Response at Week 8(8 weeks)
  • Percentage of Participants With Virological Response at Week 4(4 weeks)
  • Maximum Measured Concentration (Cmax) of Deleobuvir(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57)
  • Maximum Measured Concentration (Cmax) of Faldaprevir(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57)
  • Maximum Measured Concentration (Cmax) of CD 6168(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57)
  • Time From Last Dosing to the Maximum Concentration (Tmax) of Deleobuvir(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57)
  • Time From Last Dosing to the Maximum Concentration (Tmax) of Faldaprevir(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57)
  • Maximum Measured Concentration (Cmax) of BI 208333(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57)
  • Time From Last Dosing to the Maximum Concentration (Tmax) of CD 6168-AG(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57)
  • Area Under the Curve (AUC) of Deleobuvir(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57)
  • Time From Last Dosing to the Maximum Concentration (Tmax) of BI 208333(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57)
  • Area Under the Curve (AUC) of Faldaprevir(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57)
  • Area Under the Curve (AUC) of CD 6168(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57)
  • Predose Measured Concentration of Deleobuvir(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 11 and 57)
  • Cmax Accumulation Ratio (RA,Cmax,N) of Faldaprevir(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57)
  • Area Under the Curve (AUC) of BI 208333(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57)
  • Maximum Measured Concentration (Cmax) of CD 6168-AG(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57)
  • Area Under the Curve (AUC) of CD 6168-AG(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57)
  • Time From Last Dosing to the Maximum Concentration (Tmax) of CD 6168(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57)
  • AUC Accumulation Ratio of Faldaprevir(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57)
  • Mean Residence Time (MRTpo,ss) of Faldaprevir(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57)
  • Maximum Measured Concentration (Cmax) of RBV(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57)
  • Time From Last Dosing to the Maximum Concentration (Tmax) of RBV(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57)
  • Area Under the Curve (AUC) of RBV(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57)
  • Cmax Accumulation Ratio (RA,Cmax,N) of Deleobuvir(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57)
  • AUC Accumulation Ratio of Deleobuvir(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57)
  • Mean Residence Time (MRTpo,ss) of Deleobuvir(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57)
  • Apparent Clearance (CL/F,ss) of Deleobuvir(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57)
  • Apparent Clearance (CL/F,ss) of Faldaprevir(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57)
  • Predose Measured Concentration of Faldaprevir(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 11 and 57)
  • Cmax Accumulation Ratio of BI 208333(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57)
  • AUC Accumulation Ratio of BI 208333(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57)
  • Mean Residence Time (MRTpo,ss) of BI 208333(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57)
  • Predose Measured Concentration of BI 208333(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 11 and 57)
  • Cmax Accumulation Ratio of CD 6168(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57)
  • AUC Accumulation Ratio of CD 6168(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57)
  • Mean Residence Time (MRTpo,ss) of CD 6168(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on day 57)
  • Predose Measured Concentration of CD 6168(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 11 and 57)
  • Cmax Accumulation Ratio of CD 6168-AG(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57)
  • AUC Accumulation Ratio of CD 6168-AG(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57)
  • Mean Residence Time (MRTpo,ss) of CD 6168-AG(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on day 57)
  • Predose Measured Concentration of CD 6168-AG(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 11 and 57)
  • AUC Accumulation Ratio of RBV(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57)
  • Cmax Accumulation Ratio (RA,Cmax,57) of RBV(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57)
  • Mean Residence Time (MRTpo,ss) of RBV(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on day 57)
  • Predose Measured Concentration of RBV(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 11 and 57)

Study Sites (5)

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