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NCT Number: NCT01921855

Study of FVIIa Variant BAY86-6150 (B0189) in Subjects With Moderate or Severe Hemophilia Types A or B With or Without Inhibitors

This is the first in humans study of BAY86-6150 (B0189) in non-bleeding subjects with moderate or severe congenital hemophilia A or B with or without inhibitors. This is a randomized, double-blind, placebo-controlled, single-dose, dose escalation study. It is designed to investigate the safety, tolerability, potential immunogenicity, pharmacokinetic and pharmacodynamic profile of BAY86-6150 (B0189) and to determine a dose or range of doses to be examined in subsequent studies.

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Key information

Conditions

Hemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia B Hemorrhagic Disorders

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Warsaw, Poland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • History of moderate or severe congenital hemophilia A or B with or without inhibitors to Factor VIII (FVIII) or Factor IX (FIX)
  • Male subjects 18-65 years of age inclusive
  • Able to dismiss factor replacement therapy during the course of the study unless required for the treatment of an acute bleeding episode
  • Written informed consent
  • Willing and able to comply with the requirements of the protocol
  • Have adequate venous access
  • Willing to use an effective method of contraception until Day 30 of their study participation

Exclusion criteria

  • Received factor replacement therapy or treatment with any other procoagulant therapeutics, or any antifibrinolytic agents, including blood products, at anytime within 5 days prior to administration of investigational medicinal product (IMP)
  • Planned administration of factor replacement therapy or treatment with any other procoagulant therapeutics or any antifibrinolytic agents, including blood products, at anytime during the study period
  • Acute bleeding episode or any ongoing bleeding episode at any time within 7 days prior to administration IMP
  • Clinically relevant coagulation disorder other than congenital hemophilia A or B
  • History of angina or receiving treatment for angina
  • History of coronary atherosclerotic disease, disseminated intravascular coagulopathy, or stage 2 hypertension defined as systolic blood pressure (SBP) >/= 160 mmHg or diastolic blood pressure (DBP) >/= 90 mmHg
  • History of transient ischemic attack, stroke, myocardial infarction, coronary artery disease, congestive heart failure, or thromboembolic event
  • Active infection on day of IMP administration or septicemia at any time within 30 days prior to administration of IMP

Treatment and study plan

BAY Factor VII (BAY86-6150)

Drug

BAY Factor VII (BAY86-6150), 6.5 µg/kg body weight, will be administered as a slow intravenous (i.v.) administration over a period of 2-5 minutes (min) on Study Day 1.

Placebo

Drug

Placebo will be administered as a slow intravenous (i.v.) administration over a period of 2-5 minutes (min) on Study Day 1.

Primary outcomes

  1. Number of participants with adverse events as a measure of safety and tolerability

    Time frame: Up to Day 50

Secondary outcomes

  1. Pharmacokinetic assessment, based on plasma concentration of BAY86-6150

    Time frame: 9 time points from pre-dosing on Day 1 up to 48 hours post-dosing

  2. Pharmacodynamic assessment, based on plasma hemostasis marker level

    Time frame: 9 time points from pre-dosing on Day 1 up to 48 hours post-dosing

  3. Immunogenicity assessment, based on anti-BAY86-6150 binding antibody levels

    Time frame: 3 time points from pre-dosing on Day 1 up to Day 50

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Phase I, Randomized, Double-blind, Placebo Controlled, Single Dose Escalation Study of FVIIa Variant BAY86-6150 (B0189) in Subjects With Moderate or Severe Hemophilia Types A or B With or Without Inhibitors

Acronym: MATCHBOX

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Aug 13, 2013
Registry last updated
Aug 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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