Liver CirrhosisPhase 2NCT02226939
Antiviral Efficacy, Pharmacokinetics and Safety of BILN 2061 ZW in Patients With Cirrhosis and Chronic Hepatitis C
A Phase 2 study testing BILN 2061 ZW in people with Liver Cirrhosis and Hepatitis C, Chronic, run by Boehringer Ingelheim.
Trial summary
Study to assess the antiviral efficacy, pharmacokinetics, and tolerability of 200 mg BILN 2061 ZW in a polyethylene glycol 400 (PEG 400: ethanol) drinking solution given orally for two days bid to patients with cirrhosis and chronic Hepatitis C Virus (HCV) infection Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis, Hepatitis C, Chronic
- What is being tested?
- BILN 2061 ZW
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Sep 2002to Nov 2002
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male sex, age of 18 years or older
- Chronic Hepatitis C virus (HCV) infection
- Liver biopsy consistent with active HCV infection obtained within the last 36 months.
- No previous clinical evidence of decompensated cirrhosis. Present cirrhosis status consistent with grade A, according to Child-Turcotte-Pugh classification, confirmed at screening
- No evidence of significant gastroesophageal varices (> grade 1 or other risk factors) according to fiberoptic endoscopy performed within the last 12 months
- No evidence of Hepatocellular carcinoma (HCC) by ultrasound performed at screening
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- 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
- HCV load greater than 50,000 copies messenger ribonucleic acid (mRNA) per ml serum at screening
Who cannot join
- Women of childbearing potential or breastfeeding women. Postmenopausal women less than 6 months after last menses, surgically sterilized or hysterectomised less than 3 months after operation or not having negative serum pregnancy test
- Males not using an adequate form of contraception (condom, sterilization at least 6 months post operation) in case 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
- Evidence of gastroesophageal varices
- Any histological evidence of hepatocytic dysplasia
- Following serological constellations: Hepatitis B surface (HBs)-Ag positive OR anti-Hepatitis B core (HBc) positive with anti- HBs negative OR anti-HAV IgM positive OR anti-Human immunodeficiency Virus (HIV) positive
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- 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 of the skin)
- 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 or present Child´s B or C liver diseases -
- Bilirubin - refer to following exclusion criterion
- 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 exceeding 2.0 x upper limit of normal (ULN) at screening
- ALT or AST >= 10 x ULN at screening
- A platelet count of less than 80.000 platelets per mm3 at screening
- White blood cell count of less than 2,000 cells per mm3 at screening
- AFP > 100 ng/ml
- Splenectomy
- 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
About this study
Official title: A Randomised, Double-blind, Placebo Controlled Trial With 200 mg BILN 2061 ZW Given p.o. at Two Consecutive Days Bid to Investigate the Antiviral Efficacy, Pharmacokinetics, Safety in Patients With Cirrhosis and Chronic Hepatitis C
Study to assess the antiviral efficacy, pharmacokinetics, and tolerability of 200 mg BILN 2061 ZW in a polyethylene glycol 400 (PEG 400: ethanol) drinking solution given orally for two days bid to patients with cirrhosis and chronic Hepatitis C Virus (HCV) infection
- Conditions
- Liver Cirrhosis, Hepatitis C, Chronic
- Being tested
- BILN 2061 ZW, Placebo
- Medical subject headings
- Liver Cirrhosis, Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BILN 2061 ZWDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BILN 2061 ZW | Experimental | Not described Receives: Drug: BILN 2061 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.
Virus load (VL) as determined by number of copies of HCV mRNA per ml serum
Cobas Amplicor HCV Monitor v 2.0 (HCM-2.0, Roche Diagnostics)
Measured: up to day 14
Secondary outcomes (12)
Number of patients with relevant drug-induced changes in alanine aminotransferase (ALT)
Measured: up to day 14
Number of patients with relevant drug-induced changes in aspartate aminotransferase (AST)
Measured: up to day 14
Number of patients with relevant drug-induced changes in vital signs (pulse rate, systolic and diastolic blood pressure)
Measured: up to day 14
Number of patients with relevant drug-induced changes in electrocardiography (ECG)
Measured: up to day 14
Number of patients with relevant drug-induced changes in routine laboratory tests
Measured: up to day 14
Number of patients with adverse events
Measured: up to 35 days
Maximum concentration in plasma after a single dose administration (Cmax)
Measured: up to day 4
Area under the plasma concentration-time curve from t = 0 to t = .τ rate (AUC0-τ)
Measured: up to day 4
Time to reach Cmax following a single dose administration (tmax)
Measured: up to day 4
Total oral clearance of drug from plasma after oral administration, divided by F (CL/F)
Measured: up to day 4
Apparent volume of distribution during the terminal elimination phase (Vz/F)
Measured: up to day 4
Assessment of tolerability by investigator on a 4-point scale
Measured: day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study startSep 2002
- Primary completionNov 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 10 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
- NCT02226939
- Sponsor's protocol ID
- 605.9
- Status last verified
- Aug 2014
- First submitted
- 26 Aug 2014
- Last updated
- 27 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo Controlled Trial With 200 mg BILN 2061 ZW Given p.o. at Two Consecutive Days Bid to Investigate the Antiviral Efficacy, Pharmacokinetics, Safety in Patients With Cirrhosis and Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT02226939
- Acronym / sponsor ID
- 605.9
- Conditions
- Liver Cirrhosis, Hepatitis C, Chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 2002
- Primary completion
- Nov 2002 (actual)
- First posted
- 27 Aug 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.
Study to assess the antiviral efficacy, pharmacokinetics, and tolerability of 200 mg BILN 2061 ZW in a polyethylene glycol 400 (PEG 400: ethanol) drinking solution given orally for two days bid to patients with cirrhosis and chronic Hepatitis C Virus (HCV) infection
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BILN 2061 ZW | Experimental | Drug: BILN 2061 ZW |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female or male sex, age of 18 years or older
- Chronic Hepatitis C virus (HCV) infection
- Liver biopsy consistent with active HCV infection obtained within the last 36 months.
- No previous clinical evidence of decompensated cirrhosis. Present cirrhosis status consistent with grade A, according to Child-Turcotte-Pugh classification, confirmed at screening
- No evidence of significant gastroesophageal varices (> grade 1 or other risk factors) according to fiberoptic endoscopy performed within the last 12 months
Key exclusion criteria (27 listed)
- Women of childbearing potential or breastfeeding women. Postmenopausal women less than 6 months after last menses, surgically sterilized or hysterectomised less than 3 months after operation or not having negative serum pregnancy test
- Males not using an adequate form of contraception (condom, sterilization at least 6 months post operation) in case 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
- Evidence of gastroesophageal varices
- Any histological evidence of hepatocytic dysplasia
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 |
|---|---|---|
| BILN 2061 ZW | Drug | BILN 2061 ZW |
| Placebo | Drug | Placebo |
Primary outcome
Virus load (VL) as 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)
12 secondary outcomes
Number of patients with relevant drug-induced changes in alanine aminotransferase (ALT)
Time frame: up to day 14
Number of patients with relevant drug-induced changes in aspartate aminotransferase (AST)
Time frame: up to day 14
Number of patients with relevant drug-induced changes in vital signs (pulse rate, systolic and diastolic blood pressure)
Time frame: up to day 14
Number of patients with relevant drug-induced changes in electrocardiography (ECG)
Time frame: up to day 14
Number of patients with relevant drug-induced changes in routine laboratory tests
Time frame: up to day 14
Number of patients with adverse events
Time frame: up to 35 days
Maximum concentration in plasma after a single dose administration (Cmax)
Time frame: 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
Time to reach Cmax following a single dose administration (tmax)
Time frame: 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
Apparent volume of distribution during the terminal elimination phase (Vz/F)
Time frame: up to day 4
Assessment of tolerability by investigator on a 4-point scale
Time frame: day 3
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 27 Aug 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 2 study testing BILN 2061 ZW in people with Liver Cirrhosis and 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 9 inclusion and 27 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 27 Aug 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 phase mean?
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?
Virus load (VL) as determined by number of copies of HCV mRNA per ml serum (time frame: up to day 14). 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 27 Aug 2014.