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Trial · NCT03347422

Results by group1,053

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Part A: Percentage of Participants With Response to TreatmentBIVV00972.795% Confidence Interval 49.8 to 89.3percentage of participants
Part A: Percentage of Participants With Response to TreatmentPlacebo15.095% Confidence Interval 3.2 to 37.9percentage of participants
Part B: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)Part B: BIVV009 6.5 gTEAEs29Participants
Part B: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)Part B: BIVV009 7.5 gTEAEs7Participants
Part B: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)Part B: BIVV009 6.5 gTESAEs6Participants
Part B: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)Part B: BIVV009 7.5 gTESAEs1Participants
Part A: Mean Change From Baseline in Hemoglobin (Hgb) Level at the Treatment Assessment TimepointBIVV0092.6695% Confidence Interval 2.09 to 3.22grams per deciliter
Part A: Mean Change From Baseline in Hemoglobin (Hgb) Level at the Treatment Assessment TimepointPlacebo0.0995% Confidence Interval -0.50 to 0.68grams per deciliter
Part A: Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score at the Treatment Assessment TimepointBIVV00910.8395% Confidence Interval 7.45 to 14.22score on a scale
Part A: Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score at the Treatment Assessment TimepointPlacebo1.9195% Confidence Interval -1.65 to 5.46score on a scale
Part A: Mean Change From Baseline in Total Bilirubin Levels at the Treatment Assessment TimepointBIVV009-22.881Standard Deviation 10.401micromoles per liter
Part A: Mean Change From Baseline in Total Bilirubin Levels at the Treatment Assessment TimepointPlacebo-1.388Standard Deviation 13.901micromoles per liter
Part A: Mean Change From Baseline in Lactate Dehydrogenase (LDH) at the Treatment Assessment TimepointBIVV009-150.833Standard Deviation 160.824units per liter
Part A: Mean Change From Baseline in Lactate Dehydrogenase (LDH) at the Treatment Assessment TimepointPlacebo7.600Standard Deviation 212.690units per liter
Part A: Percentage of Participants With Solicited Symptomatic Anemia at Week 26BIVV009Fatigue31.6percentage of participants
Part A: Percentage of Participants With Solicited Symptomatic Anemia at Week 26PlaceboFatigue68.4percentage of participants
Part A: Percentage of Participants With Solicited Symptomatic Anemia at Week 26BIVV009Weakness5.3percentage of participants
Part A: Percentage of Participants With Solicited Symptomatic Anemia at Week 26PlaceboWeakness31.6percentage of participants
Part A: Percentage of Participants With Solicited Symptomatic Anemia at Week 26BIVV009Shortness of breath5.3percentage of participants
Part A: Percentage of Participants With Solicited Symptomatic Anemia at Week 26PlaceboShortness of breath36.8percentage of participants

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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