Back to results

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)

Primary Purpose

Hemophilia A

Status

Completed

Phase

Phase 1

Locations

Bulgaria

Study Type

Interventional

Intervention

Damoctocog-alfa-pegol (BAY94-9027, Jivi)

Rurioctocog alfa pegol (Adynovi)

About this trial

This is an interventional treatment trial for Hemophilia A

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

BAY94-9027 / Adynovi

Adynovi / BAY94-9027

Arm Description

Treatment sequence A-B with washout before each treatment

Treatment sequence B-A with washout before each treatment

Outcomes

Primary Outcome Measures

Area under the concentration versus time curve from time 0 to the last data point (AUC(0-tlast)) for BAY 94-9027

Area under the concentration versus time curve from time 0 to the last data point (AUC(0-tlast)) for Adynovi

Secondary Outcome Measures

Full Information

NCT ID

NCT04015492

First Posted

July 9, 2019

Last Updated

December 17, 2020

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT04015492

Brief Title

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)

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

August 8, 2019 (Actual)

Primary Completion Date

October 25, 2019 (Actual)

Study Completion Date

January 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemophilia A

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BAY94-9027 / Adynovi

Arm Type

Experimental

Arm Description

Treatment sequence A-B with washout before each treatment

Arm Title

Adynovi / BAY94-9027

Arm Type

Experimental

Arm Description

Treatment sequence B-A with washout before each treatment

Intervention Type

Biological

Intervention Name(s)

Damoctocog-alfa-pegol (BAY94-9027, Jivi)

Intervention Description

Single dose, 50 IU/kg BAY94-9027 (IU: international Units)

Intervention Type

Biological

Intervention Name(s)

Rurioctocog alfa pegol (Adynovi)

Intervention Description

Single dose, 50 IU/kg Adynovi

Primary Outcome Measure Information:

Title

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

Title

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD

City

Sofia

ZIP/Postal Code

1756

Country

Bulgaria

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing 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.

Citations:

PubMed Identifier

32974838

Citation

Solms A, Shah A, Berntorp E, Tiede A, Iorio A, Linardi C, Ahsman M, Mancuso ME, Zhivkov T, Lissitchkov T. Direct comparison of two extended half-life PEGylated recombinant FVIII products: a randomized, crossover pharmacokinetic study in patients with severe hemophilia A. Ann Hematol. 2020 Nov;99(11):2689-2698. doi: 10.1007/s00277-020-04280-3. Epub 2020 Sep 24.

Results Reference

derived

Links:

URL

http://clinicaltrials.bayer.com/

Description

Click here to find results for studies related to Bayer products

Learn more about this trial

We'll reach out to this number within 24 hrs