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Hepatitis C, ChronicPhase 1/2NCT02226952

Antiviral Efficacy, Pharmacokinetics and Safety of BILN 2061 ZW in Patients With Chronic Hepatitis C Virus Infection

A Phase 1/2 study testing BILN 2061 W, low dose, BILN 2061 W, medium dose and BILN 2061 W, high dose in people with Hepatitis C, Chronic, run by Boehringer Ingelheim.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
BILN 2061 W, low dose, BILN 2061 W, medium dose and BILN 2061 W, high dose
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
51 participants
Where
No sites listed yet
Study dates
Nov 2001to Apr 2002
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 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
  • 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)

Who cannot join

  • 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
Show all 26Show fewer
  • 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

About this study

Official title: 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.

Being tested
BILN 2061 W, low dose, BILN 2061 W, medium dose, BILN 2061 W, high dose, 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.

  • BILN 2061 W, low doseDrug

  • BILN 2061 W, medium doseDrug

  • BILN 2061 W, high doseDrug

  • PlaceboDrug

Study groups in NCT02226952
Study groupRoleWhat they receive
Group 1ExperimentalBILN 2061 W, medium dose, in patients with genotype 1, minimal fibrosis
Receives: Drug: BILN 2061 W, medium dose
Group 2ExperimentalBILN 2061 W, high dose, in patients with genotype 1, minimal fibrosis
Receives: Drug: BILN 2061 W, high dose
Group 3ExperimentalBILN 2061 W, high dose, in non-genotype 1 patients, minimal fibrosis
Receives: Drug: BILN 2061 W, high dose
Group 4ExperimentalBILN 2061 W, low dose, in patients with genotype 1, minimal fibrosis
Receives: Drug: BILN 2061 W, low dose
Group 5ExperimentalBILN 2061 W, medium dose, in patients with genotype 1, advanced fibrosis
Receives: Drug: BILN 2061 W, medium dose
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Virus load (VL) 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)

  1. Number of patients with clinically relevant changes in alanine aminotransferase (ALT)

    Measured: up to day 14

  2. Number of patients with clinically relevant changes in aspartate aminotransferase (AST)

    Measured: up to day 14

  3. Number of patients with clinically relevant changes in vital signs

    pulse rate, systolic and diastolic blood pressure

    Measured: up to day 14

  4. Number of patients with clinically relevant changes in electrocardiography (ECG)

    Measured: up to day 14

  5. Number of patients with clinically relevant changes in routine laboratory tests

    Measured: up to day 14

  6. Number of patients with adverse events

    Measured: up to 35 days

  7. Maximum concentration in plasma after a single dose administration (Cmax)

    Measured: up to day 4

  8. Area under the plasma concentration-time curve from t = 0 to t = .τ rate (AUC0-τ)

    Measured: up to day 4

  9. Time to reach Cmax following a single dose administration (tmax)

    Measured: up to day 4

  10. Total oral clearance of drug from plasma after oral administration, divided by F (CL/F)

    Measured: up to day 4

  11. Apparent volume of distribution during the terminal elimination phase (Vz/F)

    Measured: up to day 4

  12. 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.

  1. First posted27 Aug 2014 (estimated)
  2. Study startNov 2001
  3. Primary completionApr 2002

Resources

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
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02226952
Sponsor's protocol ID
605.5
Status last verified
Aug 2014
First submitted
26 Aug 2014
Last updated
27 Aug 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BILN 2061 W, low dose, BILN 2061 W, medium dose and BILN 2061 W, high dose 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 26 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 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?

Virus load (VL) 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?

On the ClinicalTrials.gov record for NCT02226952.

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.

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