Skip to main content
OpenTrials
Completed

NCT Number: NCT04085458

Study to Gain More Information on How Safe and Effective Jivi Works in Patients With Severe Hemophilia A (Post-marketing Investigation)

The goal of this study is to give gather more information on how safe and well Jivi works in patients with severe hemophilia A. Jivi has been approved by various regulatory agencies, including the FDA, Health Canada, Japanese Health Authority and the European Medicinal Agency. 25 patients will be enrolled and will stay for 1 to 2 years in this study depending on their treatment frequency. Researcher will monitor during the course of the study whether patients are developing antibodies (a protein made by the body in response to the drug) affecting the effectiveness of Jivi. In addition information on bleedings and patient's wellbeing will be collected.

Completed

Looking for future studies?

Notify Me

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 Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

UMHAT Tsaritsa Joanna-ISUL EAD Sofia, Sofia, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants must ≥ 18 years of age inclusive, at the time of signing the informed consent.
  • Participants with severe hemophilia A (FVIII: C<1%)
  • PTPs (Previously treated patients) (≥150 ED (Exposure day)) on prophylaxis treatment before enrollment
  • Participants who are immunocompetent. If human immunodeficiency virus (HIV) positive, cluster of differentiation 4 (CD4)+ lymphocyte count >200/mm*3
  • Participants who are willing to complete an eDiary
  • Male participants
  • Capable of giving signed informed consent

Exclusion criteria

  • Any other inherited or acquired bleeding disorder in addition to Hemophilia A.
  • Platelet count < 100,000/mm*3
  • Creatinine > 2x upper limit of normal
  • AST or ALT > 5x upper limit of normal (AST: aspartate aminotransferase; ALT: alanine aminotransferase)
  • The participant has a planned major surgery.
  • The participant is currently participating in another investigational drug study, or has participated in a clinical study involving an investigational drug within 30 days of signing informed consent or previous treatment in a clinical phase III study with BAY 94-9027 (now marketed as Jivi).
  • Current evidence (by central laboratory) or history of inhibitor to FVIII with a titer ≥ 0.6 Bethesda unit (BU).
  • Known hypersensitivity to the drug substance, excipients, or mouse or hamster protein.

Treatment and study plan

Damoctocog alfa pegol (Jivi, Bay94-9027)

Drug

The recommended starting dose is every 5 days treatment (45 IU/kg)- An assessment of response to treatment will be performed at the next scheduled visit after 10-15 ED (8-10 weeks). Participants may be assigned to different dosing regimens (every 7 days or 2x/week) or continue with every 5 days regimen, according to individual bleeding tendency and needs at investigator's discretion.

Primary outcomes

  1. FVIII Inhibitor Development by the Nijmegen Bethesda Assay

    Time frame: Observed for 100 exposure days (EDs), up to 2 years

    FVIII inhibitor testing was performed using the Nijmegen-modified Bethesda assay. A positive inhibitor result was defined as a threshold of ≥0.6 BU/mL at the central laboratory and had to be confirmed with a second blood sample. After confirmation of the positive result, the inhibitor was to be reported as a serious adverse event (SAE).

Secondary outcomes

  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Time frame: Observed for 100 exposure days (EDs), up to 2 years

    Treatment-emergent AEs were defined as those that started after the first dose of study drug and up to 7 days after the last dose.

  2. Development of Treatment-emergent Anti-PEG Antibodies

    Time frame: Observed for 100 exposure days (EDs), up to 2 years

    Anti-PEG antibody: antibody against the PEG moiety determined by enzyme-linked immunosorbent assay (ELISA). For participants with a positive result, IgM antibodies were tested.

  3. Annualized Bleeding Rate (ABR)

    Time frame: Observed for 100 exposure days (EDs), up to 2 years

    ABR is number of all bleeds per individual treatment period annualized to a 1-year time interval.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Post-marketing Investigation (PMI) to Assess Safety and Efficacy of Jivi (BAY 94-9027) Treatment in Participants With Hemophilia A

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 11, 2019
Registry last updated
Jul 27, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.