Trial · NCT03347396
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part A: Percentage of Participants With Response to Treatment | From Week 5 through Week 26 | Analysis was performed on Part A-full analysis set (FAS) which included all participants who received at least 1 dose (including partial dose) of study drug. Data for this outcome measure was planned to be collected and analyzed for combined population (i.e., all participants who received BIVV009 \[either at 6.5 g or 7.5 g\]). | percentage of participants | NUMBER |
| PRIMARY | Part B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Part B, 6.5 g cohort: From first dose (Week 27) up to 143 weeks of treatment + 9 weeks of follow-up (i.e., up to Week 179); Part B, 7.5 g cohort: From first dose (Week 27) up to 149 weeks of treatment + 9 weeks of follow-up (i.e., up to Week 185) | Analysis was performed on Part B safety analysis set (SAS) which included all participants who received at least 1 dose (including partial dose) of study drug in Part B. Data for this outcome measures was planned to be collected and analyzed for dose-wise reporting groups (BIVV009 6.5g and BIVV009 7.5 g). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part A: Mean Change From Baseline in Bilirubin Levels at the Treatment Assessment Timepoint | Baseline, treatment assessment timepoint (i.e., average of Week 23, 25 and 26) | Analysis was performed on Part A-FAS. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for combined population (i.e., all participants who received BIVV009 \[either at 6.5 g or 7.5 g\]). | micromoles per Liter (mcmol/L) | LEAST_SQUARES_MEAN |
| SECONDARY | Part A: Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Treatment Assessment Timepoint | Baseline, treatment assessment timepoint (i.e., average of Week 23, 25 and 26) | Analysis was performed on Part A-FAS. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for combined population (i.e., all participants who received BIVV009 \[either at 6.5 g or 7.5 g\]). | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Part A: Mean Change From Baseline in Lactate Dehydrogenase (LDH) at the Treatment Assessment Timepoint | Baseline, treatment assessment timepoint (i.e., average of Week 23, 25 and 26) | Analysis was performed on Part A-FAS. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for combined population (i.e., all participants who received BIVV009 \[either at 6.5 g or 7.5 g\]). | units per liter | LEAST_SQUARES_MEAN |
| SECONDARY | Part A: Number of Blood Transfusions Per Participant | From Week 5 up to Week 26 | Analysis was performed on Part A-FAS. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for combined population (i.e., all participants who received BIVV009 \[either at 6.5 g or 7.5 g\]). | blood transfusions per participant | MEAN |
| SECONDARY | Part A: Number of Blood Units Transfused Per Participant | From Week 5 up to Week 26 | Analysis was performed on Part A-FAS. Here, 'overall number of participants analyzed' = number of participants with at least 1 transfusion. Data for this outcome measure was planned to be collected and analyzed for combined population (i.e., all participants who received BIVV009 \[either at 6.5 g or 7.5 g\]). | blood units transfused per participant | MEAN |
| SECONDARY | Part A: Mean Change From Baseline in Hemoglobin (Hgb) Level at the Treatment Assessment Timepoint | Baseline, treatment assessment timepoint (i.e., average of Week 23, 25 and 26) | Analysis was performed on Part A-FAS. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for combined population (i.e., all participants who received BIVV009 \[either at 6.5 g or 7.5 g\]). | g/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Baseline, Weeks 27,29,31,33,35,37,39,41, 43, 45, 47, 49, 51, 53, 55, 57, 59, 61, 63, 65, 67, 69, 71, 73, 75, 77, 79, 83, 87, 91, 95, 99, 103, 107, 111, 115, 119, 123, 127, 131, 135, 139, 143, 147, 151, 155, 159, 163, 167, 171, 175, ET/SFU (up to Week 185) | Analysis was performed on Part B-FAS which included all participants who enrolled in Part B study and received at least 1 dose (including partial dose) of study drug. Here, 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was planned to be collected and analyzed for combined population (i.e., all participants who received BIVV009 \[either at 6.5 g or 7.5 g\]). | g/dL | MEAN |
| SECONDARY | Part B: Change From Baseline in Bilirubin Levels at Each Specified Time Points | Baseline, Weeks 27,29,31,33,35,37,39,41, 43, 45, 47, 49, 51, 53, 55, 57, 59, 61, 63, 65, 67, 69, 71, 73, 75, 77, 79, 83, 87, 91, 95, 99, 103, 107, 111, 115, 119, 123, 127, 131, 135, 139, 143, 147, 151, 155, 159, 163, 167, 171, 175, ET/SFU (up to Week 185) | Analysis was performed on Part B-FAS. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was planned to be collected and analyzed for combined population (i.e., all participants who received BIVV009 \[either at 6.5 g or 7.5 g\]). | mcmol/L | MEAN |
| SECONDARY | Part B: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147,159, 171 and Early Termination (ET) Visit/Safety Follow-up Visit | Baseline, Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147,159, 171 and ET Visit/SFU visit (i.e., up to Week 185) | Analysis was performed on Part B-FAS. Here, 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was planned to be collected and analyzed for combined population (i.e., all participants who received BIVV009 \[either at 6.5 g or 7.5 g\]). | score on a scale | MEAN |
| SECONDARY | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | Baseline, Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135 and ET Visit/SFU visit (i.e., up to Week 185) | Analysis was performed on Part B-FAS. Here, 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was planned to be collected and analyzed for combined population (i.e., all participants who received BIVV009 \[either at 6.5 g or 7.5 g\]). | score on a scale | MEAN |
| SECONDARY | Part B: Change From Baseline in 5-level European Quality of Life 5-Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147,159, 171 and ET Visit/SFU Visit | Baseline, Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147,159, 171 and ET Visit/SFU visit (i.e., up to Week 185) | Analysis was performed on Part B-FAS. Here, 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was planned to be collected and analyzed for combined population (i.e., all participants who received BIVV009 \[either at 6.5 g or 7.5 g\]). | score on a scale | MEAN |
| SECONDARY | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147,159, 171 and at ET Visit/SFU Visit | At Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147,159, 171 and at ET Visit/SFU visit (i.e., up to Week 185) | Analysis was performed on Part B-FAS population. Here, 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was planned to be collected and analyzed for combined population (i.e., all participants who received BIVV009 \[either at 6.5 g or 7.5 g\]). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147,159, 171 and at ET Visit/SFU Visit | At Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147,159, 171 and at ET Visit/SFU visit (i.e., up to Week 185) | Analysis was performed on Part B-FAS. Here, 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was planned to be collected and analyzed for combined population (i.e., all participants who received BIVV009 \[either at 6.5 g or 7.5 g\]). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Baseline, Weeks 27,29,31,33,35,37,39,41, 43, 45, 47, 49, 51, 53, 55, 57, 59, 61, 63, 65, 67, 69, 71, 73, 75, 77, 79, 83, 87, 91, 95, 99, 103, 107, 111, 115, 119, 123, 127, 131, 135, 139, 143, 147, 151, 155, 159, 163, 167, 171, 175, ET/SFU (up to Week 185) | Analysis was performed on Part B-FAS. Here, 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was planned to be collected and analyzed for combined population (i.e., all participants who received BIVV009 \[either at 6.5 g or 7.5 g\]). | units per liter | MEAN |
| SECONDARY | Part B: Number of Blood Transfusions Per Participant | From Week 27 up to 149 weeks of treatment (i.e., up to Week 176) | Analysis was performed on Part-B FAS. Data for this outcome measure was planned to be collected and analyzed for combined population (i.e., all participants who received BIVV009 \[either at 6.5 g or 7.5 g\]). | blood transfusions per participant | MEAN |
| SECONDARY | Part B: Number of Blood Units Transfused Per Participant | From Week 27 up to 149 weeks of treatment (i.e., up to Week 176) | Analysis was performed on Part B-FAS. Here, 'overall number of participants analyzed' = number of participants with at least 1 transfusion. Data for this outcome measure was planned to be collected and analyzed for combined population (i.e., all participants who received BIVV009 \[either at 6.5 g or 7.5 g\]). | blood units transfused per participants | MEAN |
| SECONDARY | Part B: Change From Baseline in Haptoglobin Values at Each Specified Time Points | Baseline, Weeks 27,29,31,33,35,37,39,41,43, 45, 47, 49, 51, 53, 55, 57, 59, 61, 63, 65, 67, 69, 71, 73, 75, 77, 79, 83, 87, 91, 95, 99, 103, 107, 111, 115, 119, 123, 127, 131, 135, 139, 143, 147, 151, 155, 159, 163, 167, 171, 175, ET/SFU (up to Week 185) | Analysis was performed on Part B-FAS. Here, 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was planned to be collected and analyzed for combined population (i.e., all participants who received BIVV009 \[either at 6.5 g or 7.5 g\]). | grams per liter | MEAN |
| SECONDARY | Part B: Number of Healthcare Visits by Type | From Week 27 up to 149 weeks of treatment (i.e., up to Week 176) | Analysis was performed on Part B-FAS. Data for this outcome measure was planned to be collected and analyzed for combined population (i.e., all participants who received BIVV009 \[either at 6.5 g or 7.5 g\]). | visits | NUMBER |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03347396/outcomes