Trial · NCT03818607
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | LDH Level at Week 27 (Parallel Comparison) | Week 27 | The full analysis set (FAS) included all randomized participants. | U/L | GEOMETRIC_LEAST_SQUARES_MEAN |
| PRIMARY | Time-adjusted Area Under the Effect Curve (AUEC) of LDH (Crossover Comparison Per Assigned Treatment) | From Week 13 to Week 27, from Week 39 to Week 53, and from Week 65 to Week 79 | The modified FAS included all randomized participants with an LDH-time profile evaluable for the time-adjusted AUEC, according to treatment assigned during each of the 14-week assessments during Period 1 and 2. | U*day/L/week | GEOMETRIC_LEAST_SQUARES_MEAN |
| SECONDARY | Mean Total Complement (50% Total Hemolytic Complement Activity [CH50]) | Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79 | Participants in the FAS with data available at each time point. The FAS included all randomized participants. | Percent of LLN for all CH50 values | MEAN |
| SECONDARY | Mean Total Hemoglobin Levels | Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79 | Participants in the FAS with data available at each time point. The FAS included all randomized participants. | g/L | MEAN |
| SECONDARY | Mean Serum-free Hemoglobin Levels | Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79 | Participants in the FAS with data available at each time point. The FAS included all randomized participants. | mg/dL | MEAN |
| SECONDARY | Mean Haptoglobin Levels | Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79 | Participants in the FAS with data available at each time point. The FAS included all randomized participants. | g/L | MEAN |
| SECONDARY | Mean Bilirubin Levels | Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79 | Participants in the FAS with data available at each time point. The FAS included all randomized participants. | micromol/L | MEAN |
| SECONDARY | Degree of Hemoglobinuria | Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79 | Participants in the FAS with evaluable urine samples available at each time point. The FAS included all randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Percentage of Type III Erythrocytes | Baseline, Week 27, Week 39, Week 53, Week 65 and Week 79 | Participants in the FAS with data available at each time point. The FAS included all randomized participants. | Percentage of Type III Erythrocytes | MEAN |
| SECONDARY | LDH Levels at Week 53 and Week 79 | Week 53 (first week of Period 2) and Week 79 (last week of Period 2) | Participants in the FAS with data available at each time point. The FAS included all randomized participants. | U/L | GEOMETRIC_LEAST_SQUARES_MEAN |
| SECONDARY | Mean LDH Levels by Visit up to Week 79 | Baseline, Week 3, Week 7, Week 13, Week 15, Week 19, Week 25, Week 27, Week 29, Week 33, Week 39, Week 41, Week 43, Week 45, Week 47, Week 49, Week 51, Week 53, Week 55, Week 59, Week 65, Week 67, Week 69, Week 71, Week 73, Week 75, Week 77, and Week 79 | Participants in the FAS with data available at each time point. The FAS included all randomized participants. | U/L | MEAN |
| SECONDARY | Mean Number of Packed RBC Units Transfused Per Month | Baseline to End of Study (up to Week 79) | Participants in the FAS who had packed RBC units transfused. The FAS included all randomized participants. | packed RBC units per month | MEAN |
| SECONDARY | Total and Unbound Pharmacokinetics (PK) Area Under the Curve (AUC) of ABP 959 and Eculizumab From Week 13 to Week 15 (Period 1) | PK samples were collected predose and immediately postdose Week 13, 7 days post the Week 13 dose (Week 14), and predose at Week 15 | The PK parameter analysis set consisted of a subset of participants from the safety analysis set with an evaluable ABP 959 or eculizumab serum concentration time profile from Week 13 to Week 15. | µg*day/mL | GEOMETRIC_MEAN |
| SECONDARY | Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab | PK samples were collected predose at the prespecified timepoints: baseline, Week 3, Week 7, Week 13, Week 15, Week 19, Week 27, Week 33, Week 39, Week 45, Week 51, Week 53, Week 55, Week 59, Week 65, Week 71, Week 77, and Week 79 | The PK concentration analysis set consisted of a subset of participants from the safety analysis set with at least one serum concentration (including results below the quantifiable limit) of ABP 959 or eculizumab, with data analyzed according to actual treatment received. Participants with data available at each time point are presented. | µg/mL | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Day 1 to End of Study (up to Week 79) | The safety analysis set included all treated participants, with treatment assigned based on actual treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Antidrug Antibodies (ADAs) | Blood samples for ADA assessments were taken predose at baseline, Week 3, Week 7, Week 13, Week 19, Week 25, Week 27, Week 33, Week 39, Week 45, Week 51, Week 53, Week 55, Week 59, Week 65, Week 71, Week 77 and Week 79. | The safety analysis set included all treated participants, with treatment assigned based on actual treatment received. | Participants | COUNT_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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