Study Completed

Hemophilia A

Bayer Identifier:

19742

ClinicalTrials.gov Identifier:

NCT04015492

EudraCT Number:

2018-000507-16

EU CT Number:

Not Available

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)

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

18 - 65 Years

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

Trial summary

Enrollment Goal

Trial Dates

August 2019 - January 2020

Phase

Phase 1

Could I Receive a placebo

Products

Jivi (Damoctocog, BAY94-9027)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD	Sofia, 1756, Bulgaria

Primary Outcome

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
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

Trial design

Single dose, open label, randomized, cross-over study in participants with severe hemophilia A comparing pharmacokinetic parameters of BAY 94-9027 and Adynovi

Trial Type

Interventional

Intervention Type

Biological/Vaccine

Trial Purpose

Treatment

Allocation

Randomized

Blinding

N/A

Assignment

Crossover Assignment

Trial Arms

Additional Information

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