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

NCT02226939 | Completed Phase 2

• 1 other identifier: 605.9
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Liver Cirrhosis; Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

• 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)

  up to day 14

Secondary Outcomes (12)

• Number of patients with relevant drug-induced changes in alanine aminotransferase (ALT)

  up to day 14

• Number of patients with relevant drug-induced changes in aspartate aminotransferase (AST)

  up to day 14

• Number of patients with relevant drug-induced changes in vital signs (pulse rate, systolic and diastolic blood pressure)

  up to day 14

• Number of patients with relevant drug-induced changes in electrocardiography (ECG)

  up to day 14

• Number of patients with relevant drug-induced changes in routine laboratory tests

  up to day 14

Study Arms (2)

BILN 2061 ZW

EXPERIMENTAL

Drug: BILN 2061 ZW

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BILN 2061 ZW DRUG

BILN 2061 ZW

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
• 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
• 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

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 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
• 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 -
• Prothrombin time \< 70%

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Liver Cirrhosis; Hepatitis C, Chronic

Interventions

BILN 2061

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: September 1, 2002
• Primary Completion: November 1, 2002
• Last Updated: August 27, 2014

Record last verified: 2014-08