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Study to Compare How the Body Distributes and Excretes the Drugs Jivi (BAY 94-9027) and Adynovi in Patients With Severe Hemophilia A (Bleeding Disorder Resulting From a Lack of Blood Clotting Factor VIII)

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ClinicalTrials.gov Identifier: NCT04015492
Recruitment Status : Recruiting
First Posted : July 11, 2019
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:

This study is being conducted to compare how the body distributes and excretes the drugs Jivi (BAY 94-9027) and Adynovi. Jivi is a recently approved blood clotting Factor VIII (FVIII) medication for the treatment of hemophilia A (bleeding disorder resulting from a lack of FVIII). Both drugs are FVIII products which have been manufactured via recombinant technology and have an extended half-live, i.e. they will stay longer in the body than other FVIII products. Therefore these products act longer in the body which reduces the frequency of drug injections. To compare the two drugs, a cross-over design was chosen, i.e. each patient will receive both products one after another.

Patients participating in this study will receive one dose of Jivi and one dose of Adynovi. Both drugs are injected into a vein. Observation will last for about 10 weeks, and blood samples will be taken from the participants to measure the blood levels of FVIII. Generic name of Jivi is Damoctocog-alfa-pegol, generic name of Adynovi is Rurioctocog alfa pegol.


Condition or disease Intervention/treatment Phase
Hemophilia A Biological: Damoctocog-alfa-pegol (BAY94-9027, Jivi) Biological: Rurioctocog alfa pegol (Adynovi) Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Dose, Open Label, Randomized, Cross-over Study in Participants With Severe Hemophilia A Comparing Pharmacokinetic Parameters of BAY 94-9027 and Adynovi
Actual Study Start Date : August 8, 2019
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : January 14, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia

Arm Intervention/treatment
Experimental: BAY94-9027 / Adynovi
Treatment sequence A-B with washout before each treatment
Biological: Damoctocog-alfa-pegol (BAY94-9027, Jivi)
Single dose, 50 IU/kg BAY94-9027 (IU: international Units)

Biological: Rurioctocog alfa pegol (Adynovi)
Single dose, 50 IU/kg Adynovi

Experimental: Adynovi / BAY94-9027
Treatment sequence B-A with washout before each treatment
Biological: Damoctocog-alfa-pegol (BAY94-9027, Jivi)
Single dose, 50 IU/kg BAY94-9027 (IU: international Units)

Biological: Rurioctocog alfa pegol (Adynovi)
Single dose, 50 IU/kg Adynovi




Primary Outcome Measures :
  1. Area under the concentration versus time curve from time 0 to the last data point (AUC(0-tlast)) for BAY 94-9027 [ Time Frame: Pre-dose to 120 hours after the end of the infusion ]
  2. Area under the concentration versus time curve from time 0 to the last data point (AUC(0-tlast)) for Adynovi [ Time Frame: Pre-dose to 120 hours after the end of the infusion ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants with severe hemophilia A (baseline FVIII activity FVIII:C <1%), determined by measurement at the time of screening (following a washout period of at least 72 h after their last FVIII treatment for standard half-life FVIII products or of 120 h for extended half-life FVIII products) or from reliable prior documentation (e.g. measurement in other clinical studies, result from approved clinical laboratory or diagnostic genetic testing).
  • ≥150 exposure days with FVIII concentrate(s) (plasma-derived or recombinant) as supported by medical records.
  • Body mass index (BMI) within the range 18 kg/m2 to 29.9 kg/m2 (inclusive).

Exclusion Criteria:

  • Inability to stop FVIII treatment to complete a minimum of 72 h washout for standard half-life FVIII product or 120 h washout for extended half-life FVIII product
  • Evidence of current or past inhibitor antibody
  • History of any congenital or acquired coagulation disorders other than hemophilia A
  • Platelet count <75,000/mm3
  • Human immunodeficiency virus (HIV) infection with a cluster of differentiation 4 (CD4+) lymphocyte count of <200/mm3
  • Abnormal renal function (serum creatinine >2x the upper limit of the normal range [ULN])
  • Active liver disease verified by medical history or persistently elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5x ULN or severe liver disease as evidenced by, but not limited to any of the following: International Normalized Ratio >1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices
  • Requirement of any pre-medication to tolerate FVIII treatment (e.g. anti-histamines)
  • Prior treatment with immunomodulatory agents or chemotherapy within the last 3 months prior to study entry or requirement of treatment during the study. The following drugs are allowed: α interferon, PEG interferon, highly active anti-retroviral therapy for HIV, and/or a total of two courses of pulse treatment with steroid for a maximum of 7 days at 1 mg/kg or less

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04015492


Contacts
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Contact: Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com

Locations
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Bulgaria
SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD Recruiting
Sofia, Bulgaria, 1756
Sponsors and Collaborators
Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT04015492     History of Changes
Other Study ID Numbers: 19742
2018-000507-16 ( EudraCT Number )
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.


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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:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
Coagulants