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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

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ClinicalTrials.gov Identifier: NCT02254707
Recruitment Status : Completed
First Posted : October 2, 2014
Last Update Posted : October 2, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: BILB 1941 ZW Drug: Placebo Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official 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
Study Start Date : July 2004
Actual Primary Completion Date : April 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BILB 1941 ZW
Escalating Doses
Drug: BILB 1941 ZW
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult males from 18 - 65 years
  2. Written informed consent consistent with ICH (International Conference on Harmonisation)/GCP (Good Clinical Practice) and local legislation given prior to any study procedures
  3. Chronic HCV infection demonstrated by positive HCV IgG Antibody
  4. HCV genotype 1 which has to be confirmed by central laboratory test before Visit 2
  5. 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)
  6. HCV ribonucleic acid (RNA) load greater than 100,000 IU RNA per ml serum at screening
  7. Willing to abstain from alcohol during the screening, treatment and until completion of the study (visit 11)

Exclusion Criteria:

  1. 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).
  2. Any other or additional plausible cause for chronic liver disease, including the presence of other viruses known or suspected to cause hepatitis
  3. Evidence of decompensated liver disease: ascites, portal hypertension or hepatic encephalopathy
  4. Positive test for human immunodeficiency virus (HIV) or Hepatitis B surface (HBs) antigen at screening
  5. 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).
  6. Any concurrent medical illness or disease requiring treatment or concomitant medications
  7. History of malignancy (except for previously cured squamous cell or basal cell carcinoma)
  8. 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
  9. Patients treated with interferon and/or ribavirin within 6 months prior to screening
  10. Planned or concurrent usage of any other pharmacological therapy at screening, or during the trial period, including any antiviral therapy or vaccination
  11. Known hypersensitivity to drugs or excipients
  12. 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
  13. Patients with any clinically significant laboratory abnormalities based on the investigator's medical assessment at screening
  14. Positive urine test for drug abuse at screening
  15. Patients with known Gilbert's disease
  16. 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
  17. Inability to comply with the protocol

Additional Information:
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02254707     History of Changes
Other Study ID Numbers: 1201.14
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: October 2, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antiviral Agents
Anti-Infective Agents