Trial · NCT03427060
Coversin in PNH in Patients With Resistance to Eculizumab Due to Complement C5 Polymorphisms
NCT03427060, Phase 2, Completed, AKARI Therapeutics; results first posted 2025-05-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Coversin in PNH in Patients With Resistance to Eculizumab Due to Complement C5 Polymorphisms. Trials, record NCT03427060. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03427060
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Coversin in PNH in Patients With Resistance to Eculizumab Due to Complement C5 Polymorphisms
- NCT number
- NCT03427060
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- AKARI Therapeutics
- Conditions
- Paroxysmal Nocturnal Hemoglobinuria (PNH)
- Interventions
- Coversin
- First posted
- 2018-02-09
- Last updated
- 2025-05-04
- Results first posted
- 2025-05-04
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Measurement of Serum Lactate Dehydrogenase (LDH) | Baseline to Day 186 | Measurement of serum lactate dehydrogenase (LDH) |
| Secondary | Percentage Change in Haemoglobin (Hb) Compared to Screening | Baseline to Day 186 | Percentage change in the haemoglobin (Hb) value at each study visit compared to screening |
| Secondary | Number of Packed Red Blood Cells (PRBC) Transfusions | Baseline to Day 180 | Number of units of packed red blood cells (PRBC) transfusions |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Measurement of Serum Lactate Dehydrogenase (LDH) | Baseline to Day 186 | U/L | NUMBER | |
| SECONDARY | Percentage Change in Haemoglobin (Hb) Compared to Screening | Baseline to Day 186 | %change in Hb value compare to screening | NUMBER | |
| SECONDARY | Number of Packed Red Blood Cells (PRBC) Transfusions | Baseline to Day 180 | PRBC Units | NUMBER |
Source ClinicalTrials.gov
Results by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Measurement of Serum Lactate Dehydrogenase (LDH) | Coversin Treatment | Screening | 2913 | U/L | |
| Measurement of Serum Lactate Dehydrogenase (LDH) | Coversin Treatment | Day 1 | 3056 | U/L | |
| Measurement of Serum Lactate Dehydrogenase (LDH) | Coversin Treatment | Day 3 | 1453 | U/L | |
| Measurement of Serum Lactate Dehydrogenase (LDH) | Coversin Treatment | Day 7 | 564 | U/L | |
| Measurement of Serum Lactate Dehydrogenase (LDH) | Coversin Treatment | Day 14 | 351 | U/L | |
| Measurement of Serum Lactate Dehydrogenase (LDH) | Coversin Treatment | Day 21 | 368 | U/L | |
| Measurement of Serum Lactate Dehydrogenase (LDH) | Coversin Treatment | Day 29 | 329 | U/L | |
| Measurement of Serum Lactate Dehydrogenase (LDH) | Coversin Treatment | Day 36 | 339 | U/L | |
| Measurement of Serum Lactate Dehydrogenase (LDH) | Coversin Treatment | Day 43 | 555 | U/L | |
| Measurement of Serum Lactate Dehydrogenase (LDH) | Coversin Treatment | Day 60 | 319 | U/L |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Coversin Treatment | 1 | |
| Overall Study | COMPLETED | Coversin Treatment | 1 | |
| Overall Study | NOT COMPLETED | Coversin Treatment | 0 |
Source ClinicalTrials.gov
Adverse events30
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 | Aspartate Aminotransferase Increased | Investigations | Coversin Treatment. Ablation Dose: Day 1. 60 mg and 30 mg (12 Hours Apart) | 0 | 1 | 0 |
| other | Aspartate Aminotransferase Increased | Investigations | Coversin Treatment. Initiation Dose: Days 2 - 28. 22.5 mg Twice a Day (12 Hours Apart) | 1 | 1 | 2 |
| other | Aspartate Aminotransferase Increased | Investigations | Coversin Treatment. Maintenance Dose: Days 29 - 180. 45 mg Once Daily | 0 | 1 | 0 |
| other | Hot Flush | Vascular disorders | Coversin Treatment. Ablation Dose: Day 1. 60 mg and 30 mg (12 Hours Apart) | 0 | 1 | 0 |
| other | Hot Flush | Vascular disorders | Coversin Treatment. Initiation Dose: Days 2 - 28. 22.5 mg Twice a Day (12 Hours Apart) | 1 | 1 | 2 |
| other | Hot Flush | Vascular disorders | Coversin Treatment. Maintenance Dose: Days 29 - 180. 45 mg Once Daily | 0 | 1 | 0 |
| other | Nausea | Gastrointestinal disorders | Coversin Treatment. Ablation Dose: Day 1. 60 mg and 30 mg (12 Hours Apart) | 0 | 1 | 0 |
| other | Nausea | Gastrointestinal disorders | Coversin Treatment. Initiation Dose: Days 2 - 28. 22.5 mg Twice a Day (12 Hours Apart) | 1 | 1 | 2 |
| other | Nausea | Gastrointestinal disorders | Coversin Treatment. Maintenance Dose: Days 29 - 180. 45 mg Once Daily | 0 | 1 | 0 |
| other | Urinary Tract Infection | Infections and infestations | Coversin Treatment. Ablation Dose: Day 1. 60 mg and 30 mg (12 Hours Apart) | 0 | 1 | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Coversin Treatment. Ablation Dose: Day 1. 60 mg and 30 mg (12 Hours Apart) | 0 | 1 |
| Total, all-cause mortality | Coversin Treatment. Initiation Dose: Days 2 - 28. 22.5 mg Twice a Day (12 Hours Apart) | 0 | 1 |
| Total, all-cause mortality | Coversin Treatment. Maintenance Dose: Days 29 - 180. 45 mg Once Daily | 0 | 1 |
| Total, other adverse events | Coversin Treatment. Ablation Dose: Day 1. 60 mg and 30 mg (12 Hours Apart) | 0 | 1 |
| Total, other adverse events | Coversin Treatment. Initiation Dose: Days 2 - 28. 22.5 mg Twice a Day (12 Hours Apart) | 1 | 1 |
| Total, other adverse events | Coversin Treatment. Maintenance Dose: Days 29 - 180. 45 mg Once Daily | 0 | 1 |
| Total, serious adverse events | Coversin Treatment. Ablation Dose: Day 1. 60 mg and 30 mg (12 Hours Apart) | 0 | 1 |
| Total, serious adverse events | Coversin Treatment. Initiation Dose: Days 2 - 28. 22.5 mg Twice a Day (12 Hours Apart) | 1 | 1 |
| Total, serious adverse events | Coversin Treatment. Maintenance Dose: Days 29 - 180. 45 mg Once Daily | 0 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT03427060
GET https://conductscience.org/api/trials/v1/NCT03427060/results?page=2