Hepatitis C, ChronicPhase 2NCT01528735

This Trial Evaluates Safety, Pharmacokinetic Profile and Anti-viral Response of BI 207127 and BI 201335 for Patients With Chronic Hepatitis C

A Phase 2 study testing BI 207127 NA, peginterferon and Ribavirin in people with Hepatitis C, Chronic, run by Boehringer Ingelheim at 5 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 20 to 70 years
Conditions the study is for: Hepatitis C, Chronic
What is being tested?: BI 207127 NA, peginterferon and Ribavirin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 5 sitesJapan
Study dates: Feb 2012to Aug 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 < 40 or > 125 kg at screening
Hemoglobin <12.0g/dL for women and <13.0g/dL for men at screening
White blood cell count <3000 cells/mm3 at screening

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Absolute neutrophil count < 1,500 cells/mm3 at screening
Platelet count < 90,000 /mm3 at screening
Serum creatinine > 1.5xUpper Limit of Normal range(ULN) or creatinine clearance =50 mL/min at screening

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Japan5 sites

1241.25.002 Boehringer Ingelheim Investigational Site
Kofu, Yamanashi
1241.25.005 Boehringer Ingelheim Investigational Site
Kurashiki, Okayama
1241.25.003 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
1241.25.004 Boehringer Ingelheim Investigational Site
Nishinomiya, Hyogo
1241.25.001 Boehringer Ingelheim Investigational Site
Omura, Nagasaki

Other trials in Japan

About this study

Official title: 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

Conditions: Hepatitis C, Chronic
Being tested: BI 207127 NA, peginterferon, Ribavirin, BI 201335 NA
Medical subject headings: Hepatitis C, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BI 207127 NADrug
one fix dose
peginterferonDrug
per package insert
RibavirinDrug
per weight BID
RibavirinDrug
per weight BID
BI 207127 NADrug
one fix dose
BI 201335 NADrug
high dose
BI 201335 NADrug
low dose
peginterferonDrug
per package insert

Study groups in NCT01528735
Study group	Role	What they receive
BI 207127 NA, BI 201335 NA(high dose), R	Experimental	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 Receives: Drug: peginterferon; Drug: Ribavirin; Drug: BI 207127 NA; Drug: BI 201335 NA
BI 207127 NA,BI 201335 NA(low dose),RBV	Experimental	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 Receives: Drug: BI 207127 NA; Drug: Ribavirin; Drug: BI 201335 NA; Drug: peginterferon

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients With Drug-related Adverse Events
Number of patients with investigator defined drug-related Adverse Events
Measured: From first dose of study medication until 30 days after last dose of study medication, up to 199 days

Secondary outcomes (46)

Percentage of Participants With Virological Response at Week 4
Percentage of participants with plasma HCV RNA (hepatitis C virus (HCV) ribonucleic acid (RNA)) level <25 IU/mL (undetected or detected) at week 4.
Measured: 4 weeks
Percentage of Participants With Virological Response at Week 8
Percentage of participants with plasma HCV RNA (hepatitis C virus ribonucleic acid ) level <25 IU/mL (undetected or detected) at week 8.
Measured: 8 weeks
Maximum Measured Concentration (Cmax) of Deleobuvir
Maximum measured concentration of BI 207127 (Deleobuvir) in plasma following the morning dose of Nth day (Cmax,N).
Measured: 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 Deleobuvir
Time from last dosing to the maximum concentration of Deleobuvir (BI 207127) in plasma after the morning dose of Nth day (Tmax,N).
Measured: 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
Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ.
Measured: 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
Maximum measured concentration of Faldaprevir (BI 201335 ZW) in plasma following the morning dose of Nth day (Cmax,N).
Measured: 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
Time from last dosing to the maximum concentration of Faldaprevir (BI 201335 ZW) in plasma after the morning dose of Nth day (Tmax,N).
Measured: 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
Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ.
Measured: 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
Maximum measured concentration of BI 208333 (a metabolite of Deleobuvir) in plasma following the morning dose of Nth day (Cmax,N).
Measured: 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
Time from last dosing to the maximum concentration of BI 208333 (a metabolite of Deleobuvir) in plasma after the morning dose of Nth day (Tmax,N).
Measured: 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
Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ.
Measured: 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
Maximum measured concentration of CD 6168 (a metabolite of Deleobuvir) in plasma following the morning dose of Nth day (Cmax,N).
Measured: 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 CD 6168
Time from last dosing to the maximum concentration of CD 6168 (a metabolite of Deleobuvir) in plasma after the morning dose of Nth day (Tmax,N).
Measured: 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
Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ.
Measured: 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
Maximum measured concentration of CD 6168-AG (a metabolite of Deleobuvir) in plasma following the morning dose of Nth day (Cmax,N). AG=acylglucuronide.
Measured: 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 CD 6168-AG
Time from last dosing to the maximum concentration of CD 6168-AG (a metabolite of Deleobuvir) in plasma after the morning dose of Nth day (Tmax,N). AG=acylglucuronide.
Measured: 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-AG
Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ. AG=acylglucuronide.
Measured: 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 RBV
Maximum measured concentration of ribavirin (RBV) in plasma following the morning dose of Nth day (Cmax,N).
Measured: 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
Time from last dosing to the maximum concentration of ribavirin (RBV) in plasma after the morning dose of Nth day (Tmax,N).
Measured: 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
Area under the concentration time curve (AUC) of ribavirin (RBV) in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ.
Measured: 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
Accumulation ratio of BI 207127 (Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N), and ratio of the Cmax,ss of Deleobuvir versus itself (RA,Cmax,Met,ss).
Measured: 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
Accumulation ratio of BI 207127 (Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N), and ratio of the AUC,ss of Deleobuvir versus itself (RA,AUC,Met,ss).
Measured: 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
Mean residence time of BI 207127 (Deleobuvir) in the body after oral administration at steady state (MRTpo,ss).
Measured: 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
Apparent clearance of BI 207127 (Deleobuvir) in plasma following extravascular administration on the 57th day (CL/F,ss).
Measured: 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 Deleobuvir
Predose measured concentration of BI 207127 (Deleobuvir) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss).
Measured: 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
Accumulation ratio of Faldaprevir (BI 201335 ZW) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N).
Measured: 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
Accumulation ratio of Faldaprevir (BI 201335 ZW) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N).
Measured: 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
Mean residence time of Faldaprevir (BI 201335 ZW) in the body after oral administration at steady state (MRTpo,ss).
This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups.
Measured: 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
Apparent clearance of Faldaprevir (BI 201335 ZW) in plasma following extravascular administration on the 57th day (CL/F,ss).
Measured: 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
Predose measured concentration of Faldaprevir (BI 201335 ZW) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss).
Measured: 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
Accumulation ratio of BI 208333 (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N), and ratio of the Cmax,ss of BI 208333 versus Cmax,ss of Deleobuvir (RA,Cmax,Met,ss).
Measured: 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
Accumulation ratio of BI 208333 (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N), and ratio of the AUC,ss of BI 208333 versus AUC,ss of Deleobuvir (RA,AUC,Met,ss).
Measured: 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
Mean residence time of BI 208333 (a metabolite of Deleobuvir) in the body after oral administration at steady state (MRTpo,ss).
This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups.
Measured: 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
Predose measured concentration of BI 208333 (a metabolite of Deleobuvir) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss).
Measured: 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
Accumulation ratio of CD 6168 (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N), and ratio of the Cmax,ss of CD 6168 versus Cmax,ss of Deleobuvir (RA,Cmax,Met,ss).
Measured: 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
Accumulation ratio of CD 6168 (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N), and ratio of the AUC,ss of CD 6168 versus AUC,ss of Deleobuvir (RA,AUC,Met,ss).
Measured: 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
Mean residence time of CD 6168 (a metabolite of Deleobuvir) in the body after oral administration at steady state (MRTpo,ss).
This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups.
Measured: 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
Predose measured concentration of CD 6168 (a metabolite of Deleobuvir) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss).
Measured: 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
Accumulation ratio of CD 6168-AG (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N), and ratio of the Cmax,ss of CD 6168-AG versus Cmax,ss of Deleobuvir (RA,Cmax,Met,ss). AG=acylglucuronide.
Measured: 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
Accumulation ratio of CD 6168-AG (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N), and ratio of the AUC,ss of CD 6168-AG versus AUC,ss of Deleobuvir (RA,AUC,Met,ss). AG=acylglucuronide.
Measured: 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
Mean residence time of CD 6168-AG (a metabolite of Deleobuvir) in the body after oral administration at steady state (MRTpo,ss). AG=acylglucuronide.
This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups.
Measured: 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
Predose measured concentration of CD 6168-AG (a metabolite of Deleobuvir) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss). AG=acylglucuronide.
Measured: 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
Accumulation ratio of ribavirin (RBV) in plasma after the administration of the 57th day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the 57th day and after the first dose (RA,AUC,57).
Measured: 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
Accumulation ratio of ribavirin (RBV) in plasma after the administration of the 57th day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the 57th day and after the first dose (RA,Cmax,57).
Measured: 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
Mean residence time of ribavirin (RBV) in the body after oral administration at steady state (MRTpo,ss).
This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups.
Measured: 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
Predose measured concentration of ribavirin (RBV) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss).
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2012Aug 2013

First posted8 Feb 2012 (estimated)
Study startFeb 2012
Primary completionAug 2013
Study completionAug 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01528735
Sponsor's protocol ID: 1241.25
Status last verified: Mar 2016
First submitted: 6 Feb 2012
Last updated: 13 Apr 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

Yatsuhashi H, Kodani N, Ugai H, Omata M. Open-label phase 2 study of faldaprevir, deleobuvir and ribavirin in Japanese treatment-naive patients with chronic hepatitis C virus genotype 1 infection. Hepatol Res. 2016 Mar;46(3):E189-93. doi: 10.1111/hepr.12535. Epub 2015 Jun 18.
PubMed 25991083

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01528735
Acronym / sponsor ID: 1241.25
Conditions: Hepatitis C, Chronic
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Feb 2012
Primary completion: Aug 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 8 Feb 2012 (estimated)
Results: Posted 13 Apr 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
BI 207127 NA, BI 201335 NA(high dose), R	Experimental	Drug: peginterferon, Drug: Ribavirin, Drug: BI 207127 NA, Drug: BI 201335 NAPatients receive BI 207127 NA,BI 201335 NA(high dose) and RBV for 8 wks followed by BI 201335 NA,PegIFN/RBV for 24 wks
BI 207127 NA,BI 201335 NA(low dose),RBV	Experimental	Drug: BI 207127 NA, Drug: Ribavirin, Drug: BI 201335 NA, Drug: peginterferonPatients receive BI 207127 NA,BI 201335 NA(low dose) and RBV for 8 wks followed by BI 201335 NA,PegIFN/RBV for 24 wks

Who may qualify

Ages: 20 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Chronic hepatitis C, diagnosed by positive anti-hepatitis C virus(HCV) antibodies and detected HCV ribonucleic acid(RNA) at screening in addition to:
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

Key exclusion criteria (9 listed)

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 < 40 or > 125 kg at screening
Hemoglobin <12.0g/dL for women and <13.0g/dL for men at screening

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BI 207127 NAone fix dose	Drug	BI 207127 NA,BI 201335 NA(low dose),RBV
peginterferonper package insert	Drug	BI 207127 NA, BI 201335 NA(high dose), R
Ribavirinper weight BID	Drug	BI 207127 NA,BI 201335 NA(low dose),RBV
Ribavirinper weight BID	Drug	BI 207127 NA, BI 201335 NA(high dose), R
BI 207127 NAone fix dose	Drug	BI 207127 NA, BI 201335 NA(high dose), R
BI 201335 NAhigh dose	Drug	BI 207127 NA, BI 201335 NA(high dose), R
BI 201335 NAlow dose	Drug	BI 207127 NA,BI 201335 NA(low dose),RBV
peginterferonper package insert	Drug	BI 207127 NA,BI 201335 NA(low dose),RBV

Primary outcome

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

46 secondary outcomes

Percentage of Participants With Virological Response at Week 4
Time frame: 4 weeks
Percentage of Participants With Virological Response at Week 8
Time frame: 8 weeks
Maximum Measured Concentration (Cmax) of Deleobuvir
Time frame: 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 Deleobuvir
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 CD 6168
Time frame: 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
Time frame: 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
Time frame: 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 CD 6168-AG
Time frame: 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-AG
Time frame: 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 RBV
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 Deleobuvir
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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

Results and safety

Results posted to the registry on 13 Apr 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
600mg Deleobuvir and 80mg Faldaprevir	12	11
600mg Deleobuvir and 120mg Faldaprevir	13	12

Primary outcome: 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. Unit: participants

Measure	600mg Deleobuvir and 80mg Faldaprevir n = 12	600mg Deleobuvir and 120mg Faldaprevir n = 13
Value	12	13

Population analysed: Treated Set which included all patients who were dispensed study medication and were documented to have taken at least one dose of study medication.

46 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose of study medication until 30 days after last dose of study medication, up to 199 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Faldap/Del/RBV:80mg Faldap and 600mg Del.	0 of 12 (0%)	12 of 12 (100%)	Not reported
Faldap/Del/RBV:120mg Faldap and 600mg Del.	0 of 13 (0%)	13 of 13 (100%)	Not reported
Faldap/pegIFN/RBV:80mg Faldap and 600mg Del.	1 of 11 (9.1%)	11 of 11 (100%)	Not reported
Faldap/pegIFN/RBV:120mg Faldap and 600mg Del.	0 of 12 (0%)	11 of 12 (91.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25991083Yatsuhashi H, Kodani N, Ugai H, Omata M. Open-label phase 2 study of faldaprevir, deleobuvir and ribavirin in Japanese treatment-naive patients with chronic hepatitis C virus genotype 1 infection. Hepatol Res. 2016 Mar;46(3):E189-93. doi: 10.1111/hepr.12535. Epub 2015 Jun 18.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BI 207127 NA, peginterferon and Ribavirin in people with Hepatitis C, Chronic, run by Boehringer Ingelheim at 5 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01528735, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2016.