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Completed

NCT Number: NCT02254707

Evaluation of the Antiviral Pharmacodynamic Effect, Safety, and Pharmacokinetics of Escalating Doses of BILB 1941 ZW to Patients With Chronic Hepatitis C Genotype 1 Virus Infection

To assess the antiviral effect, safety and pharmacokinetics of rising doses of 10 mg, 20 mg, 40 mg, 60 mg, 80 mg, 100 mg, 150 mg, 200 mg, 300 mg, 450 mg, 650 mg, 900 mg oral BILB 1941 ZW administered Q8H in a polyethyleneglycol 400 (PEG 400): distilled water: Tromethamine (TRIS) drinking solution for five days to patients with chronic HCV genotype 1 infection

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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–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult males from 18 - 65 years
  • Written informed consent consistent with ICH (International Conference on Harmonisation)/GCP (Good Clinical Practice) and local legislation given prior to any study procedures
  • Chronic HCV infection demonstrated by positive HCV IgG Antibody
  • HCV genotype 1 which has to be confirmed by central laboratory test before Visit 2
  • Liver biopsy consistent with active Hepatitis C virus (HCV) infection obtained within the last 24 months showing minimal to mild liver fibrosis and without cirrhosis (Ishak or Metavir grade <= 2)
  • HCV ribonucleic acid (RNA) load greater than 100,000 IU RNA per ml serum at screening
  • Willing to abstain from alcohol during the screening, treatment and until completion of the study (visit 11)

Exclusion criteria

  • Males not using an adequate form of contraception (condom, sterilisation at least 6 months post operation) in case their partner is of childbearing potential and is not using an adequate form of contraception (hormonal contraceptives, oral or injectable/implantable, intra-uterine device (IUD).
  • Any other or additional plausible cause for chronic liver disease, including the presence of other viruses known or suspected to cause hepatitis
  • Evidence of decompensated liver disease: ascites, portal hypertension or hepatic encephalopathy
  • Positive test for human immunodeficiency virus (HIV) or Hepatitis B surface (HBs) antigen at screening
  • Current alcohol or drug abuse, or history of the same, within the past twelve (12) months. All patients must abstain from alcohol from enrolment until completion of the study (visit 11).
  • Any concurrent medical illness or disease requiring treatment or concomitant medications
  • History of malignancy (except for previously cured squamous cell or basal cell carcinoma)
  • Usage of any investigational drug within thirty (30) days prior to enrolment or 5 halflives, whichever is longer; or the planned usage of an investigational drug during the course of the current study
  • Patients treated with interferon and/or ribavirin within 6 months prior to screening
  • Planned or concurrent usage of any other pharmacological therapy at screening, or during the trial period, including any antiviral therapy or vaccination
  • Known hypersensitivity to drugs or excipients
  • Patients with any one of the following laboratory values at screening:
  • Alanine transaminase (ALT) or Aspartate transaminase (AST) > 2.5 x upper limit of normal (ULN) (at screening and during the last 3 months before screening demonstrated by at least 2 further determinations)
  • Total bilirubin > 1x ULN
  • Alkaline phosphatase > 1.5x ULN
  • Prothrombin time (INR, prolonged) > 1.5
  • Platelet count < 100,000 / mm3
  • Hemoglobin < 10.5 g/dL
  • White blood cell count < 2,000 / mm3
  • Patients with any clinically significant laboratory abnormalities based on the investigator's medical assessment at screening
  • Positive urine test for drug abuse at screening
  • Patients with known Gilbert's disease
  • Prior randomisation to active treatment with BILB 1941 ZW into dose groups 3 - 9 of this trial, or previous re-treatment based on amendment 2. To support selection, centers will receive lists of the placebo patients of the previous dose levels, however, only for each center separately
  • Inability to comply with the protocol

Treatment and study plan

BILB 1941 ZW

Drug

Placebo

Drug

Primary outcomes

  1. Change in virus load (VL)

    Time frame: Up to day 6

    determined by IU per ml serum from baseline by > 1.0 log10 step

Secondary outcomes

  1. Cmax (maximum measured concentration of the analyte in plasma)

    Time frame: Up to 14 days after first drug administration

  2. tmax (time from dosing to maximum measured concentration of the analyte in plasma)

    Time frame: Up to 14 days after first drug administration

  3. AUCτ,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ after administration of the first dose)

    Time frame: Up to 14 days after first drug administration

  4. AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

    Time frame: Up to 14 days after first drug administration

  5. %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)

    Time frame: Up to 14 days after first drug administration

  6. λz (terminal rate constant in plasma)

    Time frame: Up to 14 days after first drug administration

  7. t1/2 (terminal half-life of the analyte in plasma)

    Time frame: Up to 14 days after first drug administration

  8. CL/F (apparent clearance of the analyte in plasma after extravascular administration)

    Time frame: Up to 14 days after first drug administration

  9. Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular administration)

    Time frame: Up to 14 days after first drug administration

  10. Number of patients with clinically significant changes in vital signs

    Time frame: Up to 14 days after first drug administration

  11. Number of patients with clinically significant changes in body temperature

    Time frame: Up to 14 days after first drug administration

  12. Number of patients with abnormal findings in electrocardiogram (ECG)

    Time frame: Up to 14 days after first drug administration

  13. Number of patients with abnormal changes in clinical laboratory parameters

    Time frame: Up to 14 days after first drug administration

  14. Number of patients with adverse events

    Time frame: Up to 14 days after first drug administration

  15. Number of patients with abnormal findings in physical examination

    Time frame: Up to 14 days after first drug administration

  16. Investigator assessed tolerability on a 4 point scale

    Time frame: Up to 14 days after first drug administration

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Multinational Randomised, Double-blind, Placebo Controlled Study to Evaluate the Antiviral Pharmacodynamic Effect, Safety, and Pharmacokinetics of Escalating Doses of BILB 1941 ZW Oral Solution Administered Q8H for Five Days to Patients With Chronic Hepatitis C Genotype 1 Virus Infection

Important dates

Study start
2004
Primary completion
2006
First posted
Oct 2, 2014
Registry last updated
Oct 2, 2014

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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