Hepatitis C, ChronicPhase 1/2NCT02254707
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
A Phase 1/2 study testing BILB 1941 ZW in people with Hepatitis C, Chronic, run by Boehringer Ingelheim.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- BILB 1941 ZW
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Jul 2004to Apr 2006
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 24Show fewer
- 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
About this study
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
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
- Conditions
- Hepatitis C, Chronic
- Being tested
- BILB 1941 ZW, Placebo
- 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.
BILB 1941 ZWDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BILB 1941 ZW | Experimental | Escalating Doses Receives: Drug: BILB 1941 ZW |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in virus load (VL)
determined by IU per ml serum from baseline by > 1.0 log10 step
Measured: Up to day 6
Secondary outcomes (16)
Cmax (maximum measured concentration of the analyte in plasma)
Measured: Up to 14 days after first drug administration
tmax (time from dosing to maximum measured concentration of the analyte in plasma)
Measured: Up to 14 days after first drug administration
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)
Measured: Up to 14 days after first drug administration
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: Up to 14 days after first drug administration
%AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)
Measured: Up to 14 days after first drug administration
λz (terminal rate constant in plasma)
Measured: Up to 14 days after first drug administration
t1/2 (terminal half-life of the analyte in plasma)
Measured: Up to 14 days after first drug administration
CL/F (apparent clearance of the analyte in plasma after extravascular administration)
Measured: Up to 14 days after first drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular administration)
Measured: Up to 14 days after first drug administration
Number of patients with clinically significant changes in vital signs
Measured: Up to 14 days after first drug administration
Number of patients with clinically significant changes in body temperature
Measured: Up to 14 days after first drug administration
Number of patients with abnormal findings in electrocardiogram (ECG)
Measured: Up to 14 days after first drug administration
Number of patients with abnormal changes in clinical laboratory parameters
Measured: Up to 14 days after first drug administration
Number of patients with adverse events
Measured: Up to 14 days after first drug administration
Number of patients with abnormal findings in physical examination
Measured: Up to 14 days after first drug administration
Investigator assessed tolerability on a 4 point scale
Measured: Up to 14 days after first drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study startJul 2004
- Primary completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02254707
- Sponsor's protocol ID
- 1201.14
- Status last verified
- Sep 2014
- First submitted
- 1 Oct 2014
- Last updated
- 2 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02254707
- Acronym / sponsor ID
- 1201.14
- Conditions
- Hepatitis C, Chronic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Apr 2006 (actual)
- First posted
- 2 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BILB 1941 ZW | Experimental | Drug: BILB 1941 ZWEscalating Doses |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (24 listed)
- 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).
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 |
|---|---|---|
| BILB 1941 ZW | Drug | BILB 1941 ZW |
| Placebo | Drug | Placebo |
Primary outcome
Change in virus load (VL)
Time frame: Up to day 6
determined by IU per ml serum from baseline by > 1.0 log10 step
16 secondary outcomes
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: Up to 14 days after first drug administration
tmax (time from dosing to maximum measured concentration of the analyte in plasma)
Time frame: Up to 14 days after first drug administration
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
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
%AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)
Time frame: Up to 14 days after first drug administration
λz (terminal rate constant in plasma)
Time frame: Up to 14 days after first drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: Up to 14 days after first drug administration
CL/F (apparent clearance of the analyte in plasma after extravascular administration)
Time frame: Up to 14 days after first drug administration
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
Number of patients with clinically significant changes in vital signs
Time frame: Up to 14 days after first drug administration
Number of patients with clinically significant changes in body temperature
Time frame: Up to 14 days after first drug administration
Number of patients with abnormal findings in electrocardiogram (ECG)
Time frame: Up to 14 days after first drug administration
Number of patients with abnormal changes in clinical laboratory parameters
Time frame: Up to 14 days after first drug administration
Number of patients with adverse events
Time frame: Up to 14 days after first drug administration
Number of patients with abnormal findings in physical examination
Time frame: Up to 14 days after first drug administration
Investigator assessed tolerability on a 4 point scale
Time frame: Up to 14 days after first drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BILB 1941 ZW in people with Hepatitis C, Chronic, run by Boehringer Ingelheim.
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 7 inclusion and 24 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 2 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in virus load (VL) (time frame: Up to day 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2014.