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

Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT04085458
Collaborator
(none)
32
Enrollment
13
Locations
1
Arm
33.4
Actual Duration (Months)
2.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Damoctocog alfa pegol (Jivi, BAY94-9027)
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Post-marketing Investigation (PMI) to Assess Safety and Efficacy of Jivi (BAY 94-9027) Treatment in Participants With Hemophilia A
Actual Study Start Date :
Sep 23, 2019
Actual Primary Completion Date :
May 20, 2022
Actual Study Completion Date :
Jul 5, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Severe hemophilia A patients

Prophylactic treatment regimens should be guided by clinical judgement based on individual patient characteristics and treatment response.

Drug: Damoctocog alfa pegol (Jivi, BAY94-9027)
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.

Outcome Measures

Primary Outcome Measures

  1. FVIII inhibitor development by the Nijmegen Bethesda assay [Up to 2 years]

Secondary Outcome Measures

  1. Number of participants with treatment-emergent adverse events (TEAEs) [Up to 2 years]

  2. Development of treatment-emergent anti-PEG antibodies [Up to 2 years]

  3. Annualized bleeding rate (ABR) [Up to 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 UMHAT Tsaritsa Joanna-ISUL EAD Sofia Sofia Bulgaria 1527
2 MHAT Sveta Marina EAD Varna Bulgaria 9010
3 Aarhus Universitetshospital, Skejby Arhus N Denmark 8200
4 LAIKO General Hospital of Athens Athens Greece 115 27
5 A.O. Pugliese-Ciaccio Catanzaro Calabria Italy 88100
6 A.O.U. Policlinico Umberto I Roma Lazio Italy 00161
7 Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma Lazio Italy 00168
8 Oslo Universitetssykehus HF, Rikshospitalet Oslo Norway 0372
9 Uniwersyteckie Centrum Kliniczne Gdansk Poland 80-214
10 SP Szpital Kliniczny Nr 1 Wroclaw Poland 50-367
11 Ciutat Sanitària i Universitaria de la Vall d'Hebron Barcelona Spain 08035
12 Hospital Universitario "La Paz" Madrid Spain 28046
13 Hospital Universitari i Politecnic La Fe | Hematologia Valencia Spain 46026

Sponsors and Collaborators

  • Bayer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT04085458
Other Study ID Numbers:
  • 19764
  • 2018-003655-37
First Posted:
Sep 11, 2019
Last Update Posted:
Jul 25, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Hemophilia A
Factor VIII

Study Results

No Results Posted as of Jul 25, 2022