Trial · NCT02585960
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With a Total Annualized Bleeding Rate (ABR) of Zero for Second Six Months | Day 183 to Day 364 (6 months) | Annualized bleeding rate was determined by dividing the number of bleeds by observation period in years. |
| Secondary | Total Annualized Bleeding Rate for Second Six Months | Day 183 to Day 364 (6 months) | Annualized bleeding rate was determined by dividing the number of bleeds by observation period in years. |
| Secondary | Annualized Spontaneous Bleeding Rate for Second Six Months | Day 183 to Day 364 (6 months) | Annualized spontaneous bleeding rate was determined by dividing the number of spontaneous bleeds by observation period in years. A bleed was defined as spontaneous if it was not related to injury/trauma. |
| Secondary | Annualized Traumatic Bleeding Rate for Second Six Months | Day 183 to Day 364 (6 months) | Annualized traumatic bleeding rate was determined by dividing the number of traumatic bleeds by observation period in years. A bleed was defined as traumatic if it was related to injury/trauma. |
| Secondary | Annualized Joint Bleeding Rate (AJBR) for Second Six Months | Day 183 to Day 364 (6 months) | Annualized joint bleeding rate was determined by dividing the number of joint bleeds by observation period in years. An acute joint bleed include some or all of the following: 'aura', pain, swelling, warmth of the skin over the joint, decreased range of motion and difficulty in using the limb compared with baseline or loss of function. |
| Secondary | Total Weight-adjusted Consumption of BAX 855 | From start of study treatment up to 12 months (completion or termination) | Total weight-adjusted consumption of BAX 855 were reported. |
| Secondary | Number of Bleeding Episodes: Overall Hemostatic Efficacy Rating at Number of Infusions | 8 hours after study drug administration | The participant or caregiver rated the overall treatment response using a 4-point efficacy rating scale as Excellent: Full relief of pain and cessation of objective signs of bleeding after a single infusion and no additional infusion is required for the control of bleeding; Good: Definite pain relief and/or improvement in signs of bleeding after a single infusion and possibly requires more than 1 infusion for complete resolution; Fair: Probable and/or slight relief of pain and slight improvement in signs of bleeding after a single infusion and required more than 1 infusion for complete resolution and None: No improvement or condition worsens. |
| Secondary | Number of Bleeding Episodes: Overall Hemostatic Efficacy Rating at Bleed Resolution | From start of study treatment up to bleed resolution (up to 12 months) | The participant or caregiver rated the overall treatment response using a 4-point efficacy rating scale as Excellent: Full relief of pain and cessation of objective signs of bleeding after a single infusion and no additional infusion is required for the control of bleeding; Good: Definite pain relief and/or improvement in signs of bleeding after a single infusion and possibly requires more than 1 infusion for complete resolution; Fair: Probable and/or slight relief of pain and slight improvement in signs of bleeding after a single infusion and required more than 1 infusion for complete resolution and None: No improvement or condition worsens. |
| Secondary | Treatment of Bleeding Episodes: Number of BAX 855 Infusions Per Bleeding Episode Required Until Bleed Resolution | From start of study treatment up to 12 months (completion or termination) | Infusions of BAX 855 that were required until bleed resolution were reported. |
| Secondary | Change From Baseline in Hemophilia Joint Health Score (HJHS)- Total Score | Baseline, Month 12 | HJHS was assessed based on the following components of the elbow, knee, and ankle joints: swelling, duration of swelling, muscle atrophy, crepitus on motion, flexion loss, extension loss, joint pain, and strength, together with an assessment of the global gait. The HJHS is a validated 11-item scoring tool based on radiologic and clinical evaluation, sensitive to detect early signs and minor changes. HJHS ranges from 0 to 124. Higher values in the HJHS represent worse situation for the participant. |
| Secondary | Number of Participants With Hemostatic Efficacy Ratings for BAX 855 Treatment of Operative Bleeds | Day 0 through discharge or 14 days post-surgery | The participant or caregiver rated the overall treatment response using a 4-point efficacy rating scale as Excellent: Full relief of pain and cessation of objective signs of bleeding after a single infusion and no additional infusion is required for the control of bleeding; Good: Definite pain relief and/or improvement in signs of bleeding after a single infusion and possibly requires more than 1 infusion for complete resolution; Fair: Probable and/or slight relief of pain and slight improvement in signs of bleeding after a single infusion and required more than 1 infusion for complete resolution and None: No improvement or condition worsens. Hemostatic efficacy was evaluated intra-operatively (from start to end of the procedure), post-operatively (from the end of procedure up to 24 h post procedure), and perioperatively (from the start of procedure to participant discharge from hospital or 14 days after completion of procedure; whichever was first). |
| Secondary | Blood Loss Per Participant in Case of Surgery | Day 0 through discharge or 14 days post-surgery | The intraoperative blood loss was measured by determining the volume of blood and fluid removal through suction into the collection container (waste box and/or cell saver) and the estimated blood loss into swabs and towels during the procedure, per the anesthesiologist's record. Postoperatively, blood loss was determined by the drainage volume collected, which mainly consisted of drainage fluid via vacuum or gravity drain, as applicable. In cases where no drain was present, blood loss was determined by the surgeon's clinical judgment, as applicable or entered as "not available". Blood loss was evaluated intra-operatively (from start to end of the procedure), post-operatively (from the end of procedure up to 24 h post procedure), and perioperatively (from the start of procedure to participant discharge from hospital or 14 days after completion of procedure; whichever was first). |
| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From start of study treatment up to 12 months (completion or termination) | An AE was any unfavorable and unintended sign (an abnormal laboratory finding), symptom (rash, pain, discomfort, fever, dizziness, etc.), disease (peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an investigational product (IP), whether or not considered causally related to the IP. A SAE was defined as an untoward medical occurrence that at any dose met one or more of the following criteria: outcome was fatal/results in death, life-threatening, required in-patient hospitalization or resulted in prolongation of an existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event that was not immediately life-threatening or resulted in death or required hospitalization but jeopardize the participant or required medical or surgical intervention to prevent any of the above outcomes. |
| Secondary | Number of Participants With Clinically Significant Changes in Vital Signs Reported as Treatment Related Adverse Events | From start of study treatment up to 12 months (completion or termination) | Vital signs included systolic and diastolic blood pressure, pulse rate, respiratory rate, body temperature. |
| Secondary | Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters Reported as Treatment Related Adverse Events | From start of study treatment up to 12 months (completion or termination) | Clinical laboratory assessments included clinical chemistry, hematology, lipid panel, genetics, T-cell, B-cell and NK cell (TBNK) and viral serology. |
| Secondary | Number of Participants With Positive Inhibitory Antibodies and Binding Antibodies to Factor VIII (FVIII), BAX 855, Polyethylene Glycol (PEG), and Chinese Hamster Ovary (CHO) Protein | From start of study treatment up to 12 months (completion or termination) | Positive Inhibitory Antibodies and Binding Antibodies to Factor VIII (FVIII), BAX 855, Polyethylene Glycol (PEG), and Chinese Hamster Ovary (CHO) Protein were reported here. |
| Secondary | Change From Baseline in Physical Component Scores (PCS) of the Short Form-36 (SF-36) Health Survey | Baseline, Month 12 (completion or termination) | Short Form (36) Health Survey (SF-36) is a 36-item validated, generic health related quality of life (HR QoL) instrument. PCS is a summary scale of the dimensions physical functioning, role physical, bodily pain, and general health. The component score is normalized to a standard population. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both sub-scores and summary scores. |
| Secondary | Area Under the Plasma Concentration of BAX 855 From Zero to Infinity (AUC0-inf) | Pre-infusion, 15 - 30 minutes, 3, 8, 24, 48, 72 and 96 hours post-infusion | Area under the plasma concentration versus time curve from time 0 to infinity of BAX 855 were reported. |
| Secondary | Incremental Recovery (IR) at Maximum Plasma Concentration (Cmax) of BAX 855 | Pre-infusion, 15 - 30 minutes, 3, 8, 24, 48, 72 and 96 hours post-infusion | IR at Cmax of BAX 855 were reported. |
| Secondary | Plasma Half-life (T1/2) of BAX 855 | Pre-infusion, 15 - 30 minutes, 3, 8, 24, 48, 72 and 96 hours post-infusion | T1/2 of BAX 855 in plasma were 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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