- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02226952
Antiviral Efficacy, Pharmacokinetics and Safety of BILN 2061 ZW in Patients With Chronic Hepatitis C Virus Infection
August 26, 2014 updated by: Boehringer Ingelheim
A Randomised, Double-blind, Placebo Controlled Trial With 25 mg, 200 mg and 500 mg BILN 2061 ZW Given p.o. at Two Consecutive Days Bid to Investigate the Antiviral Efficacy, Pharmacokinetics, Safety in Patients With Chronic Hepatitis C Virus Infection
Study to assess the antiviral efficacy, pharmacokinetics and tolerability of BILN 2061 ZW in a polyethyleneglycol 400 (PEG 400: ethanol) drinking solution given for two days bid in patients with chronic Hepatitis C Virus (HCV) infection.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Phase 2
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Female or male sex, age of 18 years or older
- Active, chronic Hepatitis C virus (HCV) infection
- Liver biopsy consistent with active HCV infection obtained within the last 12 months
- Written informed consent consistent with International Committee on Harmonization (ICH) / Good Clinical Practice (GCP) and local legislation given prior to any study procedures
- HCV of genotype I (Group 1, 2, 4 and 5) and non-genotype 1 (Group 3)
- HCV load greater than 50,000 copies messenger ribonucleic acid (mRNA) per ml serum at screening
- For Group 5 only: Histology showing moderate or severe fibrosis (portal fibrosis, septae, periportal and porto-central septae), no regenerative nodes and no incomplete or complete cirrhosis, corresponding to Ishak score 3 or 4, or Metavir F2 or F3 (if Ishak is not 5)
Exclusion Criteria:
- Women of childbearing potential or breastfeeding women. Postmenopausal women less than 6 months after last menses, surgically sterilized or hysterectomised patients less than 3 months after operation or without a negative serum pregnancy test
- Males not using an adequate form of contraception (condom, sterilisation at least 6 months post operation) if their partner is of childbearing potential (criteria see above) 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
- Ascites or other current evidence of portal hypertension
- Histology showing signs of bridging or higher grade fibrosis (e.g. Fibrosis >= Grade 3 (Ishak score) or >= 2 (Metavir score) for treatment groups 1, 2, 3, 4 or for Treatment group 5: Histology showing less than moderate or severe fibrosis (portal fibrosis, septae, periportal and porto-central septae), or showing regenerative nodes or incomplete or complete cirrhosis, corresponding to other Ishak scores than 3 or 4 and to other Metavir scores than F2 or F3 (or F3 and Ishak 5)
- History of abuse of alcohol within the past twelve months
- Planned or concurrent usage of any other pharmacological therapy at screening, including any antiviral therapy
- Any concurrent infectious disease requiring antimicrobial treatment
- 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 the planned usage of an investigational drug during the course of the current study
- Known hypersensitivity to drugs
- Inability to comply with the protocol
- Prior randomization into this trial
Child´s B or C liver diseases at screening (treatment groups 1, 2, 3, 4). Applicable for treatment group 5 only:
- For Bilirubin - refer to following exclusion criterion
- Quick (Prothrombin time) < 70%
- Albumin < 3.5 g/dl
- Clinical evidence of ascites
- Clinical evidence of encephalopathy
- Clinically apparent jaundice or a total bilirubin or alkaline phosphatase (AP) exceeding 1.5 x upper limit of normal (ULN) at screening (treatment groups 1, 2, 3, 4). Treatment group 5 (BILN 2061 ZW, 200 mg bid/2 days in patients with advanced liver fibrosis): Clinically apparent jaundice or a bilirubin >= 2.0 mg/dl at screening. Increased alkaline phosphatase (AP) is allowed.
- ALT or AST > 5 x ULN at screening (treatment groups 1, 2, 3, 4). Treatment group 5: ALT or AST >= 10 x ULN at screening
- A platelet count of less than 100.000 platelets per mm3 at screening
- White blood cell count of less than 2,000 cells per mm3 at screening
- Positive test for human immunodeficiency Virus (HIV) at screening
- Positive test for illicit or unprescribed drugs or medications at screening. Positive test for cannabis may be allowed if the investigator assesses this result not as clinically significant
- Patients with any clinically significant laboratory abnormalities based on the investigator's medical assessment at screening
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
|
Experimental: Group 1
BILN 2061 W, medium dose, in patients with genotype 1, minimal fibrosis
|
|
Experimental: Group 2
BILN 2061 W, high dose, in patients with genotype 1, minimal fibrosis
|
|
Experimental: Group 3
BILN 2061 W, high dose, in non-genotype 1 patients, minimal fibrosis
|
|
Experimental: Group 4
BILN 2061 W, low dose, in patients with genotype 1, minimal fibrosis
|
|
Experimental: Group 5
BILN 2061 W, medium dose, in patients with genotype 1, advanced fibrosis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Virus load (VL) determined by number of copies of HCV mRNA per ml serum
Time Frame: up to day 14
|
Cobas Amplicor HCV Monitor v 2.0 (HCM-2.0,
Roche Diagnostics)
|
up to day 14
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with adverse events
Time Frame: up to 35 days
|
up to 35 days
|
|
Maximum concentration in plasma after a single dose administration (Cmax)
Time Frame: up to day 4
|
up to day 4
|
|
Area under the plasma concentration-time curve from t = 0 to t = .τ rate (AUC0-τ)
Time Frame: up to day 4
|
up to day 4
|
|
Time to reach Cmax following a single dose administration (tmax)
Time Frame: up to day 4
|
up to day 4
|
|
Total oral clearance of drug from plasma after oral administration, divided by F (CL/F)
Time Frame: up to day 4
|
up to day 4
|
|
Apparent volume of distribution during the terminal elimination phase (Vz/F)
Time Frame: up to day 4
|
up to day 4
|
|
Assessment of tolerability by investigator on a 4-point scale
Time Frame: day 3
|
day 3
|
|
Number of patients with clinically relevant changes in alanine aminotransferase (ALT)
Time Frame: up to day 14
|
up to day 14
|
|
Number of patients with clinically relevant changes in aspartate aminotransferase (AST)
Time Frame: up to day 14
|
up to day 14
|
|
Number of patients with clinically relevant changes in vital signs
Time Frame: up to day 14
|
pulse rate, systolic and diastolic blood pressure
|
up to day 14
|
Number of patients with clinically relevant changes in electrocardiography (ECG)
Time Frame: up to day 14
|
up to day 14
|
|
Number of patients with clinically relevant changes in routine laboratory tests
Time Frame: up to day 14
|
up to day 14
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2001
Primary Completion (Actual)
April 1, 2002
Study Registration Dates
First Submitted
August 26, 2014
First Submitted That Met QC Criteria
August 26, 2014
First Posted (Estimate)
August 27, 2014
Study Record Updates
Last Update Posted (Estimate)
August 27, 2014
Last Update Submitted That Met QC Criteria
August 26, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- Hepatitis
- Hepatitis A
- Hepatitis C
- Virus Diseases
- Hepatitis C, Chronic
Other Study ID Numbers
- 605.5
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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