Trial · NCT03169972
ADYNOVATE Drug Use-Results Survey
NCT03169972, Completed, Takeda; results first posted 2025-02-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. ADYNOVATE Drug Use-Results Survey. Trials, record NCT03169972. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03169972
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ADYNOVATE Drug Use-Results Survey
- NCT number
- NCT03169972
- Status
- Completed
- Enrollment
- 135 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Hemophilia A
- Interventions
- ADYNOVATE
- First posted
- 2017-05-30
- Last updated
- 2025-02-04
- Results first posted
- 2025-02-04
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Discontinued the Use of Study Drug | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | Number of previously treated patients (PTPs) and previously untreated patients (PUPs) who discontinued the use of ADYNOVATE were reported. |
| Primary | Annual Bleed Rate (ABR) of Spontaneous Bleeding Episodes on a Prophylaxis Regimen | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | Annual bleed rate (ABR) of spontaneous bleeding episodes in PTPs and PUPs on a prophylaxis regimen were reported. Annual bleed rate is calculated by the number of bleeding episodes observed during administration period divided by the duration of administration period, after that multiplied with 365.2425. |
| Primary | Annual Bleed Rate (ABR) of Breakthrough Bleeding Episodes on a Prophylaxis Regimen | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | Annual bleed rate (ABR) of breakthrough bleeding episodes in PTPs and PUPs on a prophylaxis regimen were reported. Annual bleed rate is calculated by the number of bleeding episodes observed during administration period divided by the duration of administration period, after that multiplied with 365.2425. |
| Primary | Duration of Treatment of Study Drug on a Prophylaxis Regimen | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs. | Duration of treatment of study drug on a prophylaxis regimen was reported. |
| Primary | Duration of Treatment of Study Drug an On-Demand Regimen | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | Duration of treatment of study drug on an on-demand regimen was reported. |
| Primary | Dose Per Administration of Study Drug on a Prophylaxis Regimen | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | Dose per administration of study drug on a prophylaxis regimen was reported. |
| Primary | Dose Per Administration of Study Drug an On-Demand Regimen | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | Dose per administration of study drug on an on-demand regimen was reported. |
| Primary | Number of Doses Per a Bleeding Episode of Study Drug an On-Demand Regimen | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | Number of doses per a bleeding episode of study drug on an on-demand regimen was reported. |
| Primary | Hemostatic Effectiveness of Study Drug on Treatment of Breakthrough Bleeding Episodes With a Prophylaxis Regimen | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | Percentage of each category of hemostatic effectiveness for treatment of breakthrough bleeding episodes in a prophylaxis regimen assessed by the investigator was reported. Hemostatic effectiveness was assessed by the investigator with following 4-point ordinal scale: Excellent, Good, Fair, Poor. |
| Primary | Hemostatic Effectiveness of Study Drug on an On-Demand Regimen | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | Percentage of each category of hemostatic effectiveness for an on-demand regimen assessed by the investigator was reported. Hemostatic effectiveness was assessed by the investigator with following 4-point ordinal scale: Excellent, Good, Fair, Poor. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Discontinued the Use of Study Drug | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Annual Bleed Rate (ABR) of Spontaneous Bleeding Episodes on a Prophylaxis Regimen | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | Efficacy analysis set: all participants who received at least one dose of protocol treatment without major protocol deviation. The number analyzed was the number of participants with data available for analysis who treated with a prophylaxis regimen and experienced spontaneous bleeding episodes during the administration period. | Bleeds per year | MEDIAN |
| PRIMARY | Annual Bleed Rate (ABR) of Breakthrough Bleeding Episodes on a Prophylaxis Regimen | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | Efficacy analysis set: all participants who received at least one dose of protocol treatment without major protocol deviation. The number analyzed was the number of participants with data available for analysis who treated with a prophylaxis regimen and experienced breakthrough bleeding episodes during the administration period. | Bleeds per year | MEDIAN |
| PRIMARY | Duration of Treatment of Study Drug on a Prophylaxis Regimen | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. The number analyzed was the number of participants with data available for analysis who treated with a prophylaxis regimen during the administration period. | days | MEAN |
| PRIMARY | Duration of Treatment of Study Drug an On-Demand Regimen | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. The number analyzed was the number of participants with data available for analysis who treated with an on-demand regimen during the administration period. | days | MEAN |
| PRIMARY | Dose Per Administration of Study Drug on a Prophylaxis Regimen | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. The number analyzed was the number of participants with data available for analysis who treated with a prophylaxis regimen during the administration period. | IU per kilograms (kg) | MEAN |
| PRIMARY | Dose Per Administration of Study Drug an On-Demand Regimen | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. The number analyzed was the number of participants with data available for analysis who treated with an on-demand regimen during the administration period. | IU per kilograms (kg) | MEAN |
| SECONDARY | Number of Doses Per a Week of Study Drug on a Prophylaxis Regimen | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. The number analyzed was the number of participants with data available for analysis who treated with a prophylaxis regimen during the administration period. | Number of doses per a week | MEAN |
| PRIMARY | Number of Doses Per a Bleeding Episode of Study Drug an On-Demand Regimen | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | Efficacy analysis set: all participants who received at least one dose of protocol treatment without major protocol deviation. The number analyzed was the number of participants with data available for analysis who treated with an on-demand regimen during the administration period. | Number of doses per a bleeding episode | MEAN |
| PRIMARY | Hemostatic Effectiveness of Study Drug on Treatment of Breakthrough Bleeding Episodes With a Prophylaxis Regimen | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | Efficacy analysis set: all participants who received at least one dose of protocol treatment without major protocol deviation. The number analyzed was the number of participants with data available for analysis who treated with a prophylaxis regimen and experienced breakthrough bleeding episodes during the administration period. | Percentage of bleeding episodes | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group39
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Discontinued the Use of Study Drug | Previously Treated Patients (PTPs) | 10 | Participants | ||
| Number of Participants Who Discontinued the Use of Study Drug | Previously Untreated Patients (PUPs) | 5 | Participants | ||
| Annual Bleed Rate (ABR) of Spontaneous Bleeding Episodes on a Prophylaxis Regimen | Previously Treated Patients (PTPs) | 1.99 | Inter-Quartile Range 1.00 to 3.59 | Bleeds per year | |
| Annual Bleed Rate (ABR) of Breakthrough Bleeding Episodes on a Prophylaxis Regimen | Previously Treated Patients (PTPs) | 3.16 | Inter-Quartile Range 1.11 to 5.10 | Bleeds per year | |
| Annual Bleed Rate (ABR) of Breakthrough Bleeding Episodes on a Prophylaxis Regimen | Previously Untreated Patients (PUPs) | 2.91 | Inter-Quartile Range 2.91 to 2.91 | Bleeds per year | |
| Duration of Treatment of Study Drug on a Prophylaxis Regimen | Previously Treated Patients (PTPs) | 343.0 | Standard Deviation 69.33 | days | |
| Duration of Treatment of Study Drug on a Prophylaxis Regimen | Previously Untreated Patients (PUPs) | 510.7 | Standard Deviation 256.04 | days | |
| Duration of Treatment of Study Drug an On-Demand Regimen | Previously Treated Patients (PTPs) | 13.3 | Standard Deviation 22.42 | days | |
| Duration of Treatment of Study Drug an On-Demand Regimen | Previously Untreated Patients (PUPs) | 5.0 | Standard Deviation 2.65 | days | |
| Dose Per Administration of Study Drug on a Prophylaxis Regimen | Previously Treated Patients (PTPs) | 39.4 | Standard Deviation 12.69 | IU per kilograms (kg) |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Previously Treated Patients (PTPs) | 123 | |
| Overall Study | STARTED | Previously Untreated Patients (PUPs) | 12 | |
| Overall Study | COMPLETED | Previously Treated Patients (PTPs) | 123 | |
| Overall Study | COMPLETED | Previously Untreated Patients (PUPs) | 12 | |
| Overall Study | NOT COMPLETED | Previously Treated Patients (PTPs) | 0 | |
| Overall Study | NOT COMPLETED | Previously Untreated Patients (PUPs) | 0 |
Source ClinicalTrials.gov
Adverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Previously Treated Patients (PTPs) | 0 | 123 | |
| other | Nasopharyngitis | Infections and infestations | Previously Untreated Patients (PUPs) | 1 | 12 | |
| other | Factor VIII inhibition | Blood and lymphatic system disorders | Previously Treated Patients (PTPs) | 1 | 123 | |
| other | Factor VIII inhibition | Blood and lymphatic system disorders | Previously Untreated Patients (PUPs) | 2 | 12 | |
| other | Dermatitis atopic | Skin and subcutaneous tissue disorders | Previously Treated Patients (PTPs) | 0 | 123 | |
| other | Dermatitis atopic | Skin and subcutaneous tissue disorders | Previously Untreated Patients (PUPs) | 1 | 12 | |
| other | Eczema | Skin and subcutaneous tissue disorders | Previously Treated Patients (PTPs) | 0 | 123 | |
| other | Eczema | Skin and subcutaneous tissue disorders | Previously Untreated Patients (PUPs) | 1 | 12 | |
| other | Haemarthrosis | Musculoskeletal and connective tissue disorders | Previously Treated Patients (PTPs) | 0 | 123 | |
| other | Haemarthrosis | Musculoskeletal and connective tissue disorders | Previously Untreated Patients (PUPs) | 1 | 12 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Previously Treated Patients (PTPs) | 0 | 123 |
| Total, all-cause mortality | Previously Untreated Patients (PUPs) | 0 | 12 |
| Total, other adverse events | Previously Treated Patients (PTPs) | 1 | 123 |
| Total, other adverse events | Previously Untreated Patients (PUPs) | 5 | 12 |
| Total, serious adverse events | Previously Treated Patients (PTPs) | 2 | 123 |
| Total, serious adverse events | Previously Untreated Patients (PUPs) | 1 | 12 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Previously Treated Patients (PTPs) vs Previously Untreated Patients (PUPs): Number of Participants Who Discontinued the Use of Study Drug | Trial comparisons |
| Previously Treated Patients (PTPs) vs Previously Untreated Patients (PUPs): deaths from any cause | Trial comparisons |
| Previously Treated Patients (PTPs) vs Previously Untreated Patients (PUPs): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT03169972/results?page=2