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Completed

NCT Number: NCT00905632

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

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.

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

1241.7.3307A CHU de Grenoble, Grenoble Cédex 9, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BI 207127 middle dose +SOC

Drug

BI 207127 middle dose tid + SOC

BI 207127 high dose+SOC

Drug

BI 207127 high dose tid +SOC

Placebo + SOC

Drug

Placebo tid +SOC

BI 207127 low dose + SOC

Drug

BI 207127 low dose tid + SOC

Primary outcomes

  1. 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.

    Time frame: 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 outcomes

  1. Viral Load (Log10) at Each Visit up to Day 28, Change From Baseline

    Time frame: 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.

  2. Viral Load at Each Visit up to Day 28

    Time frame: Baseline and days 8, 15, 22 and 28

    Viral load (VL) (original values) at each visit up to day 28.

  3. Number of Participants With Virologic Response at Day 28

    Time frame: 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

  4. Number of Participants With Rapid Virological Response

    Time frame: 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.

  5. Number of Participants With Early Virological Response

    Time frame: 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)

  6. Number of Participants With End of Treatment Response

    Time frame: 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.

  7. Number of Participants With Sustained Virological Response

    Time frame: 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).

  8. Plasma Concentration Time Profiles of BI 207127

    Time frame: 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

  9. Plasma Concentration Time Profiles of CD 6168

    Time frame: 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

  10. Cmax of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State)

    Time frame: 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

  11. Tmax of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State)

    Time frame: 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).

  12. AUC0-6 of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State)

    Time frame: 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

  13. Cpre Pharmacokinetic Parameter of BI 207127 and CD 6168

    Time frame: 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.

  14. C6,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose

    Time frame: 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).

  15. AUC0-infinity,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose

    Time frame: 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

  16. λz Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose

    Time frame: 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

  17. t1/2,ss and MRTpo,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose

    Time frame: 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

  18. RA,Cmax Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose

    Time frame: 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.

  19. Number of Participants With Clinical Relevant Abnormalities for Vital Signs, Body Temperature, Physical Examination, Blood Chemistry, Haematology, Coagulation, Urinalysis and ECG

    Time frame: 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.

  20. Number of Participants With Discontinuations Due to AEs

    Time frame: 4 weeks

    Number of participants with adverse events (AEs) leading to discontinuation of trial drug

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Safety, Antiviral Activity, and Pharmacokinetics of BI 207127 NA Administered in Combination With Peg-IFN and Ribavirin in Chronic HCV-infected Patients for 4 Weeks, a Randomised, Double-blind, Placebo Controlled Study

Important dates

Study start
2009
Primary completion
2011
First posted
May 20, 2009
Registry last updated
Apr 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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