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

NCT02226952 | Completed Phase 1

• 1 other identifier: 605.5
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (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)

  up to day 14

Secondary Outcomes (12)

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

  up to day 14

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

  up to day 14

• Number of patients with clinically relevant changes in vital signs

  up to day 14

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

  up to day 14

• Number of patients with clinically relevant changes in routine laboratory tests

  up to day 14

Study Arms (6)

Group 1

EXPERIMENTAL

BILN 2061 W, medium dose, in patients with genotype 1, minimal fibrosis

Drug: BILN 2061 W, medium dose

Group 2

EXPERIMENTAL

BILN 2061 W, high dose, in patients with genotype 1, minimal fibrosis

Drug: BILN 2061 W, high dose

Group 3

EXPERIMENTAL

BILN 2061 W, high dose, in non-genotype 1 patients, minimal fibrosis

Drug: BILN 2061 W, high dose

Group 4

EXPERIMENTAL

BILN 2061 W, low dose, in patients with genotype 1, minimal fibrosis

Drug: BILN 2061 W, low dose

Group 5

EXPERIMENTAL

BILN 2061 W, medium dose, in patients with genotype 1, advanced fibrosis

Drug: BILN 2061 W, medium dose

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BILN 2061 W, low dose DRUG

Group 4

BILN 2061 W, medium dose DRUG

Group 1; Group 5

BILN 2061 W, high dose DRUG

Group 2; Group 3

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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:
• Quick (Prothrombin time) \< 70%

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2014
• First Posted: August 27, 2014
• Study Start: November 1, 2001
• Primary Completion: April 1, 2002
• Last Updated: August 27, 2014

Record last verified: 2014-08