A Clinical Trial to Evaluate Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants Without Inhibitors (HAVEN 3)
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ClinicalTrials.gov Identifier: NCT02847637 |
Recruitment Status :
Completed
First Posted : July 28, 2016
Results First Posted : November 14, 2018
Last Update Posted : June 22, 2022
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Sponsor:
Hoffmann-La Roche
Collaborator:
Chugai Pharmaceutical
Information provided by (Responsible Party):
Hoffmann-La Roche
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Hemophilia A |
Intervention |
Drug: Emicizumab |
Enrollment | 152 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | A total of 161 participants were screened, of which 9 failed screening and 152 who previously received either episodic or prophylactic treatment with FVIII agents were enrolled in this study. Participants in Arms A, B, and C were randomized in a 2:2:1 ratio; participants in Arm D were enrolled without randomization. |
Arm/Group Title | C: No Prophylaxis | A: Emicizumab 1.5 mg/kg/Week | B: Emicizumab 3 mg/kg/2 Weeks | D: Emicizumab 1.5 mg/kg/Week (Pre-study FVIII Prophylaxis) |
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Participants who had received episodic treatment with FVIII prior to study entry were randomized to continue episodic FVIII treatment when they started the trial; they were given the opportunity to switch to emicizumab prophylaxis after completing 24 weeks of no prophylaxis. | Participants who had received episodic treatment with FVIII prior to study entry were randomized to receive emicizumab prophylaxis at a dose of 3 milligrams per kilogram per week (mg/kg/week) subcutaneously (SC) for 4 weeks, followed by 1.5 mg/kg/week emicizumab SC until the end of study. | Participants who had received episodic treatment with FVIII prior to study entry were randomized to receive emicizumab prophylaxis at a dose of 3 mg/kg/week SC for 4 weeks, followed by 3 mg/kg/2 weeks emicizumab SC until the end of study. | Participants who had received FVIII prophylaxis prior to study entry were enrolled to receive emicizumab prophylaxis at a dose of 3 mg/kg/week SC for 4 weeks, followed by 1.5 mg/kg/week emicizumab SC until the end of study. |
Period Title: Overall Study | ||||
Started | 18 | 36 | 35 | 63 |
Completed 24 Weeks on No Prophylaxis | 16 [1] | 0 | 0 | 0 |
Switched to Emicizumab 3 mg/kg/2 Weeks | 16 | 0 | 0 | 0 |
Completed 24 Weeks Emicizumab Treatment | 1 [2] | 35 | 34 | 58 |
Completed | 1 | 1 | 0 | 0 |
Not Completed | 17 | 35 | 35 | 63 |
Reason Not Completed | ||||
Withdrew from treatment due to AE | 0 | 0 | 1 | 0 |
Ongoing treatment with emicizumab | 16 | 35 | 34 | 63 |
First emicizumab dose delayed | 1 | 0 | 0 | 0 |
[1]
One participant switched to emicizumab prior to completing 24 weeks No Prophylaxis (at 23.5 weeks).
[2]
Participants started on 24 weeks No Prophylaxis first before switching to emicizumab.
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Baseline Characteristics
Arm/Group Title | C: No Prophylaxis | A: Emicizumab 1.5 mg/kg/Week | B: Emicizumab 3 mg/kg/2 Weeks | D: Emicizumab 1.5 mg/kg/Week (Pre-study FVIII Prophylaxis) | Total | |
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Participants who had received episodic treatment with FVIII prior to study entry were randomized to continue episodic FVIII treatment when they started the trial; they were given the opportunity to switch to emicizumab prophylaxis after completing 24 weeks of no prophylaxis. | Participants who had received episodic treatment with FVIII prior to study entry were randomized to receive emicizumab prophylaxis at a dose of 3 milligrams per kilogram per week (mg/kg/week) subcutaneously (SC) for 4 weeks, followed by 1.5 mg/kg/week emicizumab SC until the end of study. | Participants who had received episodic treatment with FVIII prior to study entry were randomized to receive emicizumab prophylaxis at a dose of 3 mg/kg/week SC for 4 weeks, followed by 3 mg/kg/2 weeks emicizumab SC until the end of study. | Participants who had received FVIII prophylaxis prior to study entry were enrolled to receive emicizumab prophylaxis at a dose of 3 mg/kg/week SC for 4 weeks, followed by 1.5 mg/kg/week emicizumab SC until the end of study. | Total of all reporting groups | |
Overall Number of Baseline Participants | 18 | 36 | 35 | 63 | 152 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 18 participants | 36 participants | 35 participants | 63 participants | 152 participants | |
37.8 (12.9) | 39.8 (14.0) | 40.4 (11.4) | 36.4 (14.4) | 38.3 (13.5) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 18 participants | 36 participants | 35 participants | 63 participants | 152 participants | |
Female |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Male |
18 100.0%
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36 100.0%
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35 100.0%
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63 100.0%
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152 100.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 18 participants | 36 participants | 35 participants | 63 participants | 152 participants | |
Hispanic or Latino |
0 0.0%
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4 11.1%
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5 14.3%
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7 11.1%
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16 10.5%
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Not Hispanic or Latino |
17 94.4%
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32 88.9%
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30 85.7%
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53 84.1%
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132 86.8%
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Unknown or Not Reported |
1 5.6%
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0 0.0%
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0 0.0%
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3 4.8%
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4 2.6%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 18 participants | 36 participants | 35 participants | 63 participants | 152 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Asian |
4 22.2%
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6 16.7%
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10 28.6%
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12 19.0%
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32 21.1%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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1 2.8%
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0 0.0%
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0 0.0%
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1 0.7%
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Black or African American |
3 16.7%
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3 8.3%
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1 2.9%
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1 1.6%
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8 5.3%
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White |
11 61.1%
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24 66.7%
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20 57.1%
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47 74.6%
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102 67.1%
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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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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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2 5.6%
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4 11.4%
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3 4.8%
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9 5.9%
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Number of Participants with <9 or ≥9 Bleeds in the Last 24 Weeks Prior to Study Entry
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 18 participants | 36 participants | 35 participants | 63 participants | 152 participants |
Less Than (<) 9 Bleeds |
4 22.2%
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9 25.0%
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5 14.3%
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53 84.1%
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71 46.7%
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Greater Than or Equal To (≥) 9 Bleeds |
14 77.8%
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27 75.0%
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30 85.7%
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10 15.9%
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81 53.3%
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Number of Target Joints in the Last 24 Weeks Prior to Study Entry
[1] Mean (Standard Deviation) Unit of measure: Target joints |
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Number Analyzed | 18 participants | 36 participants | 35 participants | 63 participants | 152 participants | |
2.2 (1.4) | 2.1 (1.4) | 2.2 (1.7) | 1.0 (1.6) | 1.7 (1.6) | ||
[1]
Measure Description: A target joint was defined as at least 3 bleeds into the same joint over the last 24 weeks prior to study entry.
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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 Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Name/Title: | Medical Communications |
Organization: | Hoffmann-La Roche |
Phone: | 800-821-8590 |
EMail: | genentech@druginfo.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT02847637 |
Other Study ID Numbers: |
BH30071 2016-000072-17 ( EudraCT Number ) |
First Submitted: | July 26, 2016 |
First Posted: | July 28, 2016 |
Results First Submitted: | September 14, 2018 |
Results First Posted: | November 14, 2018 |
Last Update Posted: | June 22, 2022 |