Hemophilia APhase 1NCT03364998
BAY94-9027 PK Study Comparing to Another Long Acting Product
A Phase 1 study testing Damoctocog (Jivi, BAY94-9027) and Elocta in people with Hemophilia A, run by Bayer at 1 site in Bulgaria.
Trial summary
The purpose of this study is to compare the pharmacokinetics of BAY94-9027 and Elocta after intravenous administration. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Hemophilia A
- What is being tested?
- Damoctocog (Jivi, BAY94-9027) and Elocta
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteBulgaria
- Study dates
- 30 Nov 2017to 28 Sep 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males, age 18 to 65 years.
- Subjects with Severe Hemophilia A with a documented plasma FVIII level of < 1%
- ≥ 150 exposure days with FVIII concentrate(s) as supported by medical records
Who cannot join
- Evidence of current or past inhibitor antibody:
- History of any congenital or acquired coagulation disorders other than hemophilia A.
- Platelet count <75,000/mm*3.
- Abnormal renal function (serum creatinine >2 x the upper limit of the normal range).
- Active liver disease verified by medical history or persistently elevated alanine aminotransferase or aspartate aminotransferase >5 x the upper limit of the normal range 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.
Trial locations and contacts
1 site in 1 country.
Bulgaria1 site
SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD
Sofia, 1756
About this study
Official title: Single Dose, Open Label, Randomized, Crossover Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters of BAY 94 9027 and Elocta
The purpose of this study is to compare the pharmacokinetics of BAY94-9027 and Elocta after intravenous administration.
- Conditions
- Hemophilia A
- Being tested
- Damoctocog (Jivi, BAY94-9027), Elocta
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Damoctocog (Jivi, BAY94-9027)Drug
60 international units (IU)/kg, given as a 10 minute injection, 1 dose
EloctaDrug
60 IU/kg, given as a 10 minute injection, 1 dose
| Study group | Role | What they receive |
|---|---|---|
| BAY94-9027 and Elocta | Experimental | Subjects received two treatments: 60 IU/kg BAY94-9027 in the first period, followed by 60 IU/kg Elocta in the second period, with a washout period before each treatment Receives: Drug: Damoctocog (Jivi, BAY94-9027); Drug: Elocta |
| Elocta and BAY94-9027 | Experimental | Subjects received two treatments: 60 IU/kg Elocta in the first period, followed by 60 IU/kg BAY94-9027 in the second period, with a washout period before each treatment Receives: Drug: Damoctocog (Jivi, BAY94-9027); Drug: Elocta |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC from time 0 to the last data point
Area under the concentration time profile curve.
Measured: Pre-Dose and up to 120 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start30 Nov 2017
- Primary completion25 Jan 2018
- Study completion28 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each subject will receive the two treatments. Pharmacokinetic samples will be collected from pre-dose until 120 hours after the end of the injection of the single dose in each treatment arm.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364998
- Sponsor's protocol ID
- 19096
- Other IDs
- 2017-003201-18, 2017
- Status last verified
- Sep 2019
- First submitted
- 30 Nov 2017
- Last updated
- 9 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Shah A, Solms A, Wiegmann S, Ahsman M, Berntorp E, Tiede A, Iorio A, Mancuso ME, Zhivkov T, Lissitchkov T. Direct comparison of two extended-half-life recombinant FVIII products: a randomized, crossover pharmacokinetic study in patients with severe hemophilia A. Ann Hematol. 2019 Sep;98(9):2035-2044. doi: 10.1007/s00277-019-03747-2. Epub 2019 Jun 24.
PubMed 31236667
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose, Open Label, Randomized, Crossover Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters of BAY 94 9027 and Elocta
- ClinicalTrials.gov ID
- NCT03364998
- Acronym / sponsor ID
- 19096
- Conditions
- Hemophilia A
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 25 Jan 2018 (actual)
- Study completion
- 28 Sep 2018 (actual)
- First posted
- 7 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the pharmacokinetics of BAY94-9027 and Elocta after intravenous administration.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each subject will receive the two treatments. Pharmacokinetic samples will be collected from pre-dose until 120 hours after the end of the injection of the single dose in each treatment arm.
| Arm | Type | Receives |
|---|---|---|
| BAY94-9027 and Elocta | Experimental | Drug: Damoctocog (Jivi, BAY94-9027), Drug: EloctaSubjects received two treatments: 60 IU/kg BAY94-9027 in the first period, followed by 60 IU/kg Elocta in the second period, with a washout period before each treatment |
| Elocta and BAY94-9027 | Experimental | Drug: Damoctocog (Jivi, BAY94-9027), Drug: EloctaSubjects received two treatments: 60 IU/kg Elocta in the first period, followed by 60 IU/kg BAY94-9027 in the second period, with a washout period before each treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males, age 18 to 65 years.
- Subjects with Severe Hemophilia A with a documented plasma FVIII level of < 1%
- ≥ 150 exposure days with FVIII concentrate(s) as supported by medical records
Key exclusion criteria (5 listed)
- Evidence of current or past inhibitor antibody:
- History of any congenital or acquired coagulation disorders other than hemophilia A.
- Platelet count <75,000/mm*3.
- Abnormal renal function (serum creatinine >2 x the upper limit of the normal range).
- Active liver disease verified by medical history or persistently elevated alanine aminotransferase or aspartate aminotransferase >5 x the upper limit of the normal range 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Damoctocog (Jivi, BAY94-9027)60 international units (IU)/kg, given as a 10 minute injection, 1 dose | Drug | BAY94-9027 and Elocta, Elocta and BAY94-9027 |
| Elocta60 IU/kg, given as a 10 minute injection, 1 dose | Drug | BAY94-9027 and Elocta, Elocta and BAY94-9027 |
Primary outcome
AUC from time 0 to the last data point
Time frame: Pre-Dose and up to 120 hours post dose
Area under the concentration time profile curve.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Derived from this study: PubMed 31236667Shah A, Solms A, Wiegmann S, Ahsman M, Berntorp E, Tiede A, Iorio A, Mancuso ME, Zhivkov T, Lissitchkov T. Direct comparison of two extended-half-life recombinant FVIII products: a randomized, crossover pharmacokinetic study in patients with severe hemophilia A. Ann Hematol. 2019 Sep;98(9):2035-2044. doi: 10.1007/s00277-019-03747-2. Epub 2019 Jun 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Damoctocog (Jivi, BAY94-9027) and Elocta in people with Hemophilia A, run by Bayer at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC from time 0 to the last data point (time frame: Pre-Dose and up to 120 hours post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03364998, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2019.