Trial · NCT03169972
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| 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. |
| 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 | Number of doses per a week of study drug on a prophylaxis regimen was reported. |
| Secondary | Number of Participants Who Experience Factor VIII Inhibition, Dermatitis Atopic or Eczema as an Adverse Event (AE) | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | Number of PTPs and PUPs who experienced factor VIII inhibition, dermatitis atopic or eczema as an AE related to development of inhibitors, shock or anaphylaxis was reported. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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