A Safety, Tolerability, and Pharmacokinetics Study of a Single Intravenous Injection of Recombinant Coagulation Factor VIII Fc - Von Willebrand Factor - XTEN Fusion Protein (rFVIIIFc-VWF-XTEN) (BIVV001) in Previously Treated Adults With Severe Hemophilia A (EXTEN-A)
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| ClinicalTrials.gov Identifier: NCT03205163 |
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Recruitment Status :
Completed
First Posted : July 2, 2017
Results First Posted : December 2, 2019
Last Update Posted : April 19, 2022
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Sponsor:
Bioverativ, a Sanofi company
Information provided by (Responsible Party):
Sanofi ( Bioverativ, a Sanofi company )
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Non-Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Other |
| Condition |
Hemophilia A |
| Interventions |
Biological: Advate (Low Dose) Biological: Advate (High Dose) Biological: BIVV001 (Low Dose) Biological: BIVV001 (High Dose) |
| Enrollment | 16 |
Participant Flow
| Recruitment Details | The study was conducted in Japan and United States between 28 August 2017 to 12 November 2018. |
| Pre-assignment Details | A total of 16 participants were enrolled, 7 participants to low dose cohort (LDC) and 9 to high dose cohort (HDC). |
| Arm/Group Title | Low Dose Cohort (LDC): Advate 25 IU/kg Then BIVV001 25 IU/kg | High Dose Cohort (HDC): Advate 65 IU/kg Then BIVV001 65 IU/kg |
|---|---|---|
 Arm/Group Description |
Participants received a single intravenous (IV) dose of Advate 25 International Units per kilogram (IU/kg) on Day 1 of Advate treatment period (ATP) (3 days) followed by a single IV dose of BIVV001 25 IU/kg in BIVV001 treatment period (BTP) (28 days). ATP consisted of a washout of at least 72 hours which was started from the time of Advate dosing. | Participants received a single IV dose of Advate 65 IU/kg on Day 1 of ATP (4 days) followed by a single IV dose of BIVV001 65 IU/kg in BTP (28 days). ATP consisted of a washout of at least 96 hours which was started from the time of Advate dosing. |
| Period Title: ATP (LDC: 3 Days; HDC: 4 Days) | ||
| Started | 7 | 9 |
| Safety Population | 7 | 9 |
| Completed | 6 | 9 |
| Not Completed | 1 | 0 |
| Reason Not Completed | ||
| Sponsor Decision | 1 | 0 |
| Period Title: BTP (LDC: 28 Days; HDC: 28 Days) | ||
| Started | 6 | 9 |
| Safety Population | 6 | 9 |
| Completed | 6 | 9 |
| Not Completed | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | LDC: Advate 25 IU/kg Then BIVV001 25 IU/kg | HDC: Advate 65 IU/kg Then BIVV001 65 IU/kg | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Participants received a single IV dose of Advate 25 IU/kg on Day 1 of ATP (3 days) followed by a single IV dose of BIVV001 25 IU/kg in BTP (28 days). ATP consisted of a washout of at least 72 hours which was started from the time of Advate dosing. | Participants received a single IV dose of Advate 65 IU/kg on Day 1 of ATP (4 days) followed by a single IV dose of BIVV001 65 IU/kg in BTP (28 days). ATP consisted of a washout of at least 96 hours which was started from the time of Advate dosing. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 7 | 9 | 16 | |
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Baseline Analysis Population Description |
Baseline population included all enrolled participants.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 7 participants | 9 participants | 16 participants | |
| 33.0 (13.81) | 44.0 (11.65) | 39.2 (13.43) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 7 participants | 9 participants | 16 participants | |
| Female |
0 0.0%
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0 0.0%
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0 0.0%
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| Male |
7 100.0%
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9 100.0%
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16 100.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 7 participants | 9 participants | 16 participants | |
| American Indian or Alaska Native |
0 0.0%
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1 11.1%
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1 6.3%
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| Asian |
1 14.3%
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1 11.1%
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2 12.5%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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| Black or African American |
0 0.0%
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0 0.0%
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0 0.0%
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| White |
6 85.7%
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7 77.8%
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13 81.3%
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| More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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| Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
Results Point of Contact
| Name/Title: | Trial Transparency Team |
| Organization: | Bioverativ, a Sanofi company |
| Phone: | 800-633-1610 ext 6 |
| EMail: | Contact-US@sanofi.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sanofi ( Bioverativ, a Sanofi company ) |
| ClinicalTrials.gov Identifier: | NCT03205163 |
| Other Study ID Numbers: |
TDU16220 242HA101 ( Other Identifier: Bioverativ, a Sanofi company ) |
| First Submitted: | June 29, 2017 |
| First Posted: | July 2, 2017 |
| Results First Submitted: | November 11, 2019 |
| Results First Posted: | December 2, 2019 |
| Last Update Posted: | April 19, 2022 |