Hemophilia APhase 1NCT02483208
Single Dose Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters for BAY81-8973 and Advate
A Phase 1 study testing BAY81-8973 and Advate 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 BAY81-8973 and Advate 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?
- BAY81-8973 and Advate
- 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
- Jun 2015to Dec 2015
- 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/mm3
- Abnormal renal function (serum creatinine >2 times the upper limit of the normal [ULN] range)
- Active liver disease verified by medical history or persistently elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times the ULN or severe liver disease as evidenced by, but not limited to any of the following: International Normalized Ratio (INR) >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.
About this study
Official title: Single Dose, Open-label, Randomized, Crossover Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters for BAY81-8973 and Advate
The purpose of this study is to compare the pharmacokinetics of BAY81-8973 and Advate after intravenous administration.
- Conditions
- Hemophilia A
- Being tested
- BAY81-8973, Advate
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY81-8973Drug
BAY81-8973 infusion to analyze pharmacokinetics
AdvateDrug
Advate infusion to analyze pharmacokinetics.
| Study group | Role | What they receive |
|---|---|---|
| BAY81-8973 | Experimental | BAY81-8973 infusion to analyze pharmacokinetics Receives: Drug: BAY81-8973 |
| Advate | Other | Advate infusion to analyze pharmacokinetics. Receives: Drug: Advate |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC(0-tlast)
Area under the blood concentration vs time curve from zero to the last data point > lower limit of quantification
Measured: Pre-Dose, 0.25, 0.5, 1, 3, 6, 8, 24, 30, 48 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJul 2015
- Study completionDec 2015
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
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02483208
- Sponsor's protocol ID
- 17608
- Other IDs
- 2014-005173-36, 2014
- Status last verified
- Feb 2016
- First submitted
- 24 Jun 2015
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Shah A, Solms A, Garmann D, Katterle Y, Avramova V, Simeonov S, Lissitchkov T. Improved Pharmacokinetics with BAY 81-8973 Versus Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method: A Randomized Pharmacokinetic Study in Patients with Severe Hemophilia A. Clin Pharmacokinet. 2017 Sep;56(9):1045-1055. doi: 10.1007/s40262-016-0492-2.
PubMed 28005225
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. 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 for BAY81-8973 and Advate
- ClinicalTrials.gov ID
- NCT02483208
- Acronym / sponsor ID
- 17608
- Conditions
- Hemophilia A
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 Jun 2015 (estimated)
- 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 BAY81-8973 and Advate after intravenous administration.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAY81-8973 | Experimental | Drug: BAY81-8973BAY81-8973 infusion to analyze pharmacokinetics |
| Advate | Other | Drug: AdvateAdvate infusion to analyze pharmacokinetics. |
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
Key exclusion criteria (5 listed)
- Evidence of current or past inhibitor antibody
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 |
|---|---|---|
| BAY81-8973BAY81-8973 infusion to analyze pharmacokinetics | Drug | BAY81-8973 |
| AdvateAdvate infusion to analyze pharmacokinetics. | Drug | Advate |
Primary outcome
AUC(0-tlast)
Time frame: Pre-Dose, 0.25, 0.5, 1, 3, 6, 8, 24, 30, 48 hours after treatment
Area under the blood concentration vs time curve from zero to the last data point > lower limit of quantification
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 17 Feb 2016.
- Derived from this study: PubMed 28005225Shah A, Solms A, Garmann D, Katterle Y, Avramova V, Simeonov S, Lissitchkov T. Improved Pharmacokinetics with BAY 81-8973 Versus Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method: A Randomized Pharmacokinetic Study in Patients with Severe Hemophilia A. Clin Pharmacokinet. 2017 Sep;56(9):1045-1055. doi: 10.1007/s40262-016-0492-2.
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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.
Bayer Study Director study director
Bayer
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 BAY81-8973 and Advate 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 17 Feb 2016. 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(0-tlast) (time frame: Pre-Dose, 0.25, 0.5, 1, 3, 6, 8, 24, 30, 48 hours after treatment). 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 NCT02483208, 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 17 Feb 2016.