Trial · NCT03347422
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
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 randomized participants who received at least 1 dose (including partial dose) of study drug (BIVV009 or placebo). Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 \[either at 6.5 or 7.5 g\] and placebo in Part A. | percentage of participants | NUMBER |
| PRIMARY | Part B: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs) | Part B, 6.5 g cohort: From first dose (Week 26) up to 149 weeks of treatment + 9 weeks of follow-up (i.e., up to Week 184); Part B, 7.5 g cohort: From first dose (Week 26) up to 137 weeks of treatment + 9 weeks of follow-up (i.e., up to Week 172) | Analyzed 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 separately for each dose of BIVV009 (6.5 g and 7.5 g). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part A: Mean Change From Baseline in Hemoglobin (Hgb) Level at the Treatment Assessment Timepoint | Baseline (Week 0), treatment assessment timepoint (i.e., average of Week 23, 25 and 26) | Analysis was performed on Part A-FAS. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 \[either at 6.5 or 7.5 g\] and placebo in Part A. | grams per deciliter | LEAST_SQUARES_MEAN |
| SECONDARY | Part A: Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score at the Treatment Assessment Timepoint | Baseline (Week 0), treatment assessment timepoint (i.e., average of Week 23, 25 and 26) | Analysis was performed on Part A-FAS. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 \[either 6.5 g or 7.5 g\]) and placebo in Part A. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Part A: Mean Change From Baseline in Total Bilirubin Levels at the Treatment Assessment Timepoint | Baseline (Week 0), 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 of BIVV009 (i.e., all participants who received BIVV009 \[either at 6.5 or 7.5 g\] and placebo in Part A. | micromoles per liter | MEAN |
| SECONDARY | Part A: Mean Change From Baseline in Lactate Dehydrogenase (LDH) at the Treatment Assessment Timepoint | Baseline (Week 0), 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 of BIVV009 (i.e., all participants who received BIVV009 \[either 6.5 g or 7.5 g\]) and placebo in Part A. | units per liter | MEAN |
| SECONDARY | Part A: Percentage of Participants With Solicited Symptomatic Anemia at Week 26 | 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 of BIVV009 (i.e., all participants who received BIVV009 \[either 6.5 g or 7.5 g\]) and placebo in Part A. | percentage of participants | NUMBER |
| SECONDARY | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Baseline (Week 0), every 2 weeks starting from Week 27 till Week 175 and at ET/SFU visit (i.e., up to Week 184) | Analyzed on Part B-FAS which included all participants who enrolled in Part B and received at least 1 dose (including partial dose) of study drug (BIVV009). 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 of BIVV009 (i.e., all participants who received BIVV009 \[either 6.5 g or 7.5 g\]). | grams per deciliter | MEAN |
| SECONDARY | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Baseline (Week 0), every 2 weeks starting from Week 27 till Week 175 and at ET/SFU visit (i.e., up to Week 184) | 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 of BIVV009 (i.e., all participants who received BIVV009 \[either 6.5 g or 7.5 g\]). | micromoles per liter | MEAN |
| SECONDARY | Part B: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Each Specified Time Points | Baseline (Week 0), Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147, 159, 171 and ET Visit/SFU visit (i.e., up to Week 184) | Analysis was performed on Part B-FAS. Here, 'number analyzed'=participants with available data for each specified category and 0 in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 \[either 6.5 g or 7.5 g\]). | 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 (Week 0), Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147, 159, 171 and ET Visit/SFU visit (i.e., up to Week 184) | Analysis was performed on Part B-FAS. Here, 'number analyzed'=participants with available data for each specified category and 0 in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 \[either 6.5 g or 7.5 g\]). | 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 Each Specified Time Points | Baseline (Week 0), Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147, 159, 171 and ET Visit/SFU visit (i.e., up to Week 184) | Analysis was performed on Part B-FAS. Here, 'number analyzed'=participants with available data for each specified category and 0 in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 \[either 6.5 g or 7.5 g\]). | score on a scale | MEAN |
| SECONDARY | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | Baseline (Week 0), Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147, 159, 171 and ET Visit/SFU visit (i.e., up to Week 184) | Analysis was performed on Part B-FAS. Here, 'number analyzed' = participants with available data for each specified category and 0 in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 \[either 6.5 g or 7.5 g\]). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | Baseline (Week 0), Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147, 159, 171 and ET Visit/SFU visit (i.e., up to Week 184) | Analysis was performed on Part B-FAS. Here, 'number analyzed' = participants with available data for each specified category and 0 in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 \[either 6.5 g or 7.5 g\]). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Baseline (Week 0), every 2 weeks starting from Week 27 till Week 175 and at ET/SFU visit (i.e., up to Week 184) | Analysis was performed on Part B-FAS. Here, 'number analyzed' = participants with available data for each specified category and 0 in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 \[either 6.5 g or 7.5 g\]). | 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 of BIVV009 (i.e., all participants who received BIVV009 \[either 6.5 g or 7.5 g\]). | blood transfusions per participant | MEAN |
| SECONDARY | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Baseline (Week 0), every 2 weeks starting from Week 27 till Week 175 and at ET/SFU visit (i.e., up to Week 184) | Analysis was performed on Part B-FAS. Here, 'number analyzed' = participants with available data for each specified category and 0 in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 \[either 6.5 g or 7.5 g\]). | 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 of BIVV009 (i.e., all participants who received BIVV009 \[either 6.5 g or 7.5 g\]). | 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.
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