Trial · NCT03818607
A Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Participants With PNH
NCT03818607, Phase 3, Completed, Amgen; results first posted 2023-05-23
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Participants With PNH. Trials, record NCT03818607. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03818607
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Participants With PNH
- NCT number
- NCT03818607
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 42 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Paroxysmal Nocturnal Hemoglobinuria
- Interventions
- ABP 959, Eculizumab
- First posted
- 2019-01-28
- Last updated
- 2023-05-23
- Results first posted
- 2023-05-23
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | LDH Level at Week 27 (Parallel Comparison) | Week 27 | The primary analysis for the parallel comparison was hemolysis as measured by LDH at Week 27 by initial treatment received (Period 1). |
| 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 primary analysis for the crossover comparison was hemolysis, as measured by the time-adjusted AUEC of LDH, according to treatment assigned during each of the 14-week assessments during Periods 1 and 2. |
| Secondary | Mean Total Complement (50% Total Hemolytic Complement Activity [CH50]) | Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79 | Total complement (%) was measured in serum using an assay method and compared the total hemolytic complement activity to the lower limit of the normal human reference (LLN) of 58 U/mL for all CH50 values. The percent of LLN of CH50 at each time point was calculated as mean CH50 results/LLN x 100%. Baseline was defined as the last non-missing assessment taken prior to the first dose of IP. |
| Secondary | Mean Total Hemoglobin Levels | Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79 | Baseline was defined as the last non-missing assessment taken prior to the first dose of IP. |
| Secondary | Mean Serum-free Hemoglobin Levels | Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79 | Baseline was defined as the last non-missing assessment taken prior to the first dose of IP. |
| Secondary | Mean Haptoglobin Levels | Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79 | Baseline was defined as the last non-missing assessment taken prior to the first dose of IP. |
| Secondary | Mean Bilirubin Levels | Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79 | Baseline was defined as the last non-missing assessment taken prior to the first dose of IP. |
| Secondary | Degree of Hemoglobinuria | Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79 | The degree of hemoglobinuria was categorized as negative, trace, small, moderate, and large based on the analysis of urine samples collected from each participant at the specified time points. Baseline was defined as the last non-missing assessment taken prior to the first dose of IP. |
| Secondary | Mean Percentage of Type III Erythrocytes | Baseline, Week 27, Week 39, Week 53, Week 65 and Week 79 | As a measure of hemolysis the mean percentage of Type III erythrocytes was measured at the specified timepoints. Baseline was defined as the last non-missing assessment taken prior to the first dose of IP. |
| Secondary | LDH Levels at Week 53 and Week 79 | Week 53 (first week of Period 2) and Week 79 (last week of Period 2) | The analysis of the crossover comparison of hemolysis, as measured by LDH at Week 53 and Week 79. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group298
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| LDH Level at Week 27 (Parallel Comparison) | ABP 959 | 205.69 | 95% Confidence Interval 191.23 to 221.24 | U/L | |
| LDH Level at Week 27 (Parallel Comparison) | Eculizumab | 193.53 | 95% Confidence Interval 180.80 to 207.17 | U/L | |
| Time-adjusted Area Under the Effect Curve (AUEC) of LDH (Crossover Comparison Per Assigned Treatment) | ABP 959 | 1445.76 | 95% Confidence Interval 1295.63 to 1613.28 | U*day/L/week | |
| Time-adjusted Area Under the Effect Curve (AUEC) of LDH (Crossover Comparison Per Assigned Treatment) | Eculizumab | 1473.44 | 95% Confidence Interval 1321.86 to 1642.41 | U*day/L/week | |
| Mean Total Complement (50% Total Hemolytic Complement Activity [CH50]) | ABP 959/Eculizumab | Baseline | 6.4 | Standard Deviation 13.48 | Percent of LLN for all CH50 values |
| Mean Total Complement (50% Total Hemolytic Complement Activity [CH50]) | Eculizumab/ABP 959 | Baseline | 2.6 | Standard Deviation 4.11 | Percent of LLN for all CH50 values |
| Mean Total Complement (50% Total Hemolytic Complement Activity [CH50]) | ABP 959/Eculizumab | Week 27 | 7.5 | Standard Deviation 16.68 | Percent of LLN for all CH50 values |
| Mean Total Complement (50% Total Hemolytic Complement Activity [CH50]) | Eculizumab/ABP 959 | Week 27 | 6.3 | Standard Deviation 12.25 | Percent of LLN for all CH50 values |
| Mean Total Complement (50% Total Hemolytic Complement Activity [CH50]) | ABP 959/Eculizumab | Week 39 | 7.4 | Standard Deviation 23.80 | Percent of LLN for all CH50 values |
| Mean Total Complement (50% Total Hemolytic Complement Activity [CH50]) | Eculizumab/ABP 959 | Week 39 | 5.1 | Standard Deviation 10.36 | Percent of LLN for all CH50 values |
1 to 10 of 298Source ClinicalTrials.gov
See all 298 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 (Week 1 to Week 52) | STARTED | ABP 959/Eculizumab | 20 | |
| Period 1 (Week 1 to Week 52) | STARTED | Eculizumab/ABP 959 | 22 | |
| Period 1 (Week 1 to Week 52) | Participants Treated | ABP 959/Eculizumab | 20 | |
| Period 1 (Week 1 to Week 52) | Participants Treated | Eculizumab/ABP 959 | 22 | |
| Period 1 (Week 1 to Week 52) | COMPLETED | ABP 959/Eculizumab | 20 | |
| Period 1 (Week 1 to Week 52) | COMPLETED | Eculizumab/ABP 959 | 21 | |
| Period 1 (Week 1 to Week 52) | NOT COMPLETED | ABP 959/Eculizumab | 0 | |
| Period 1 (Week 1 to Week 52) | NOT COMPLETED | Eculizumab/ABP 959 | 1 | |
| Period 2 (Week 53 to Week 79) | STARTED | ABP 959/Eculizumab | 20 | |
| Period 2 (Week 53 to Week 79) | STARTED | Eculizumab/ABP 959 | 21 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events364
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Period 1: ABP 959 | 4 | 20 | |
| other | Anaemia | Blood and lymphatic system disorders | Period 1: Eculizumab | 4 | 22 | |
| other | Anaemia | Blood and lymphatic system disorders | Period 2: ABP 959 | 3 | 21 | |
| other | Anaemia | Blood and lymphatic system disorders | Period 2: Eculizumab | 1 | 20 | |
| other | Haemolysis | Blood and lymphatic system disorders | Period 1: ABP 959 | 2 | 20 | |
| other | Haemolysis | Blood and lymphatic system disorders | Period 1: Eculizumab | 2 | 22 | |
| other | Haemolysis | Blood and lymphatic system disorders | Period 2: ABP 959 | 0 | 21 | |
| other | Haemolysis | Blood and lymphatic system disorders | Period 2: Eculizumab | 2 | 20 | |
| other | Leukopenia | Blood and lymphatic system disorders | Period 1: ABP 959 | 1 | 20 | |
| other | Leukopenia | Blood and lymphatic system disorders | Period 1: Eculizumab | 0 | 22 |
1 to 10 of 364Source ClinicalTrials.gov
See all 364 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Period 1: ABP 959 | 0 | 20 |
| Total, all-cause mortality | Period 1: Eculizumab | 0 | 22 |
| Total, all-cause mortality | Period 2: ABP 959 | 0 | 21 |
| Total, all-cause mortality | Period 2: Eculizumab | 0 | 20 |
| Total, other adverse events | Period 1: ABP 959 | 15 | 20 |
| Total, other adverse events | Period 1: Eculizumab | 20 | 22 |
| Total, other adverse events | Period 2: ABP 959 | 17 | 21 |
| Total, other adverse events | Period 2: Eculizumab | 18 | 20 |
| Total, serious adverse events | Period 1: ABP 959 | 3 | 20 |
| Total, serious adverse events | Period 1: Eculizumab | 1 | 22 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39171864 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03818607
GET https://conductscience.org/api/trials/v1/NCT03818607/results?page=2