Trial · NCT03829449
rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study
NCT03829449, Phase 3, Terminated, AKARI Therapeutics; results first posted 2025-03-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study. Trials, record NCT03829449. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03829449
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study
- NCT number
- NCT03829449
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 15 participants, actual
- Lead sponsor
- AKARI Therapeutics
- Conditions
- Paroxysmal Nocturnal Hemoglobinuria
- Interventions
- rVA576
- First posted
- 2019-02-04
- Last updated
- 2025-04-10
- Results first posted
- 2025-03-12
- Limitations and caveats
Due to the early termination of this study, only a subset of the outputs planned were produced. Parent trial locked databases were not pooled with the AK581 database, limiting the scope of the analyses that could be produced. The 'parent trial baseline' could not be used in calculations.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Long Term Safety and Efficacy of rVA576 (Coversin) Therapy Assessed by AEs, SAEs, Standard Lab Tests and ECG Results. | On entry and every 3 months thereafter, for the duration of the study (approximately 3 years and 5 months) | To determine the safety profile of long-term rVA576 (Coversin) treatment as assessed by AEs, SAEs, Standard Lab tests and ECG results. |
| Secondary | Proportion of Subjects With Thrombotic and Haemolytic Event Free Status During Each 3month Time Period Since the Start of the Study. | On entry and every 3 months thereafter, for the duration of the study (approximately 3 years and 5 months) | Thrombotic and Haemolytic Events will include, but are not limited to, the following: haemolytic anaemia, thrombocytopenia, red blood cell haemolysis indicated by dark urine, Budd-Chiara syndrome, any other thrombotic or haemolytic event deemed to be associated with PNH. A haemolytic event will be defined as a rise in LDH or other biochemical evidence of haemolysis accompanied by an increase in symptoms and/or frank haemoglobinuria. Increased symptoms without objective haematological or biochemical evidence of haemolysis will not be counted as haemolytic events. In addition, the following signs and symptoms may be reviewed and classified as Thrombotic/Haemolytic events if appropriate: Acute kidney failure, Hypertension, Myocardial infarction, Stroke, Lung complications, Seizure, Coma, Premature death. |
| Secondary | Time to Thrombotic or Haemolytic Event Since Joining This Study. | Approximately 3 years and 5 months | Time to thrombotic or haemolytic event since joining this study. |
| Secondary | Proportion of Subjects Who Require PRBC Transfusion During Each 3-month Period Since the Start of the Study and Over the Entire Period of the Study | On entry and every 3 months thereafter, for the duration of the study (approximately 3 years and 5 months) | Proportion of subjects who require PRBC transfusion during each 3-month period since the start of the study and over the entire period of the study |
| Secondary | Time to First Transfusion Since Joining the Study. | approximately 3 years and 5 months | Time to first transfusion since joining the study. |
| Secondary | Proportion of Subjects With no Adverse Change in Overall Scores of Quality of Life Using the EORTC QLQ-C30, the EQ-5D-5L and FACIT-F Instruments at Each 3-month Time Period Since the Start of the Study. | Every 3 months up to 39 months | Proportion of subjects with no adverse change in overall scores of Quality of Life using the EORTC QLQ-C30, the EQ-5D-5L and FACIT-F instruments at each 3-month time period since the start of the study. |
| Secondary | Proportion of Subjects With Serum Lactate Dehydrogenase (LDH) <1.8, >1.8 to 2.4, >2.4 to 3, and >3 Times the Upper Limit of Normal (ULN) at Each 3-month Time Period Since the Start of the Study. | 12 weeks | Proportion of subjects with serum Lactate Dehydrogenase (LDH) \<1.8, \>1.8 to 2.4, \>2.4 to 3, and \>3 times the upper limit of normal (ULN) at each 3-month time period since the start of the study. |
| Secondary | Proportion of Subjects With Median Serum Lactate Dehydrogenase (LDH) <1.8, >1.8 to 2.4, >2.4 to 3, and >3 Times the Upper Limit of Normal (ULN) Over the Entire Duration of the Study. | Approximately 3 years and 5 months | Proportion of subjects with median serum Lactate Dehydrogenase (LDH) \<1.8, \>1.8 to 2.4, \>2.4 to 3, and \>3 times the upper limit of normal (ULN) over the entire duration of the study. |
| Secondary | Proportion of Transfusion-independent Subjects at Each 3-month Time Point, With Haemoglobin (g/L) Above the Baseline Haemoglobin Value They Had at the Start of the Trial From Which They Entered CONSERVE | Baseline and every 3 months up to 39 months | Proportion of transfusion-independent subjects at each 3-month time point, with haemoglobin (g/L) above the baseline haemoglobin value they had at the start of the trial from which they entered CONSERVE |
| Secondary | Proportion of Transfusion-independent Subjects Over the Entire Duration of the Study With Mean Haemoglobin (g/L) Above the Baseline Haemoglobin Value They Had at the Start of the Trial From Which They Entered CONSERVE | Approximately 3 years and 5 months | Proportion of transfusion-independent subjects over the entire duration of the study with mean haemoglobin (g/L) above the baseline haemoglobin value they had at the start of the trial from which they entered CONSERVE |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Long Term Safety and Efficacy of rVA576 (Coversin) Therapy Assessed by AEs, SAEs, Standard Lab Tests and ECG Results. | On entry and every 3 months thereafter, for the duration of the study (approximately 3 years and 5 months) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of Subjects With Thrombotic and Haemolytic Event Free Status During Each 3month Time Period Since the Start of the Study. | On entry and every 3 months thereafter, for the duration of the study (approximately 3 years and 5 months) | Data are not available for all 15 participants at every 3-month interval due to the early termination of the trial. The proportion of subjects with thrombotic or haemolytic event free status in each 3-month interval is calculated based on the actual number of participants analysed at each 3-month interval. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Thrombotic or Haemolytic Event Since Joining This Study. | Approximately 3 years and 5 months | days since first dose | MEAN | |
| SECONDARY | Proportion of Subjects Who Require PRBC Transfusion During Each 3-month Period Since the Start of the Study and Over the Entire Period of the Study | On entry and every 3 months thereafter, for the duration of the study (approximately 3 years and 5 months) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to First Transfusion Since Joining the Study. | approximately 3 years and 5 months | days | MEDIAN | |
| SECONDARY | Proportion of Subjects With no Adverse Change in Overall Scores of Quality of Life Using the EORTC QLQ-C30, the EQ-5D-5L and FACIT-F Instruments at Each 3-month Time Period Since the Start of the Study. | Every 3 months up to 39 months | Not all participants completed the self-reported questionnaires at all timepoints | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Subjects With Serum Lactate Dehydrogenase (LDH) <1.8, >1.8 to 2.4, >2.4 to 3, and >3 Times the Upper Limit of Normal (ULN) at Each 3-month Time Period Since the Start of the Study. | 12 weeks | Participants | NUMBER | |
| SECONDARY | Proportion of Subjects With Median Serum Lactate Dehydrogenase (LDH) <1.8, >1.8 to 2.4, >2.4 to 3, and >3 Times the Upper Limit of Normal (ULN) Over the Entire Duration of the Study. | Approximately 3 years and 5 months | Participants | NUMBER | |
| SECONDARY | Proportion of Transfusion-independent Subjects at Each 3-month Time Point, With Haemoglobin (g/L) Above the Baseline Haemoglobin Value They Had at the Start of the Trial From Which They Entered CONSERVE | Baseline and every 3 months up to 39 months | Total number of subjects analyzed at each timepoint is specified. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Transfusion-independent Subjects Over the Entire Duration of the Study With Mean Haemoglobin (g/L) Above the Baseline Haemoglobin Value They Had at the Start of the Trial From Which They Entered CONSERVE | Approximately 3 years and 5 months | Total number of subjects analyzed with post-baseline values is specified. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group121
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Long Term Safety and Efficacy of rVA576 (Coversin) Therapy Assessed by AEs, SAEs, Standard Lab Tests and ECG Results. | rVA576 | Adverse Events | 14 | Participants | |
| Long Term Safety and Efficacy of rVA576 (Coversin) Therapy Assessed by AEs, SAEs, Standard Lab Tests and ECG Results. | rVA576 | Serious Adverse Events | 3 | Participants | |
| Long Term Safety and Efficacy of rVA576 (Coversin) Therapy Assessed by AEs, SAEs, Standard Lab Tests and ECG Results. | rVA576 | Clinically significant hemoglobin (low) | 7 | Participants | |
| Long Term Safety and Efficacy of rVA576 (Coversin) Therapy Assessed by AEs, SAEs, Standard Lab Tests and ECG Results. | rVA576 | Clinically significant hematocrit (low) | 6 | Participants | |
| Long Term Safety and Efficacy of rVA576 (Coversin) Therapy Assessed by AEs, SAEs, Standard Lab Tests and ECG Results. | rVA576 | Clinically significant MCH (high) | 4 | Participants | |
| Long Term Safety and Efficacy of rVA576 (Coversin) Therapy Assessed by AEs, SAEs, Standard Lab Tests and ECG Results. | rVA576 | Clinically significant MCV (high) | 3 | Participants | |
| Long Term Safety and Efficacy of rVA576 (Coversin) Therapy Assessed by AEs, SAEs, Standard Lab Tests and ECG Results. | rVA576 | Clinically significant RBC (low) | 6 | Participants | |
| Long Term Safety and Efficacy of rVA576 (Coversin) Therapy Assessed by AEs, SAEs, Standard Lab Tests and ECG Results. | rVA576 | Clinically significant reticulocytes (high) | 4 | Participants | |
| Long Term Safety and Efficacy of rVA576 (Coversin) Therapy Assessed by AEs, SAEs, Standard Lab Tests and ECG Results. | rVA576 | Clinically significant basophils (low) | 1 | Participants | |
| Long Term Safety and Efficacy of rVA576 (Coversin) Therapy Assessed by AEs, SAEs, Standard Lab Tests and ECG Results. | rVA576 | Clinically significant eosinophils (low) | 1 | Participants |
1 to 10 of 121Source ClinicalTrials.gov
See all 121 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | rVA576 Coversin | 15 | |
| Overall Study | COMPLETED | rVA576 Coversin | 13 | |
| Overall Study | NOT COMPLETED | rVA576 Coversin | 2 |
Source ClinicalTrials.gov
Adverse events54
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 | Urinary tract infection | Infections and infestations | rVA576 Coversin | 5 | 15 | 8 |
| other | Upper respiratory tract infection | Infections and infestations | rVA576 Coversin | 3 | 15 | 3 |
| other | Bronchitis | Infections and infestations | rVA576 Coversin | 2 | 15 | 4 |
| other | Nasopharyngitis | Infections and infestations | rVA576 Coversin | 2 | 15 | 2 |
| other | Cystitis | Infections and infestations | rVA576 Coversin | 1 | 15 | 1 |
| other | Rhinitis | Infections and infestations | rVA576 Coversin | 1 | 15 | 1 |
| other | Respiratory tract infection viral | Infections and infestations | rVA576 Coversin | 1 | 15 | 1 |
| other | Pneumonia | Infections and infestations | rVA576 Coversin | 1 | 15 | 1 |
| other | Pharyngitis | Infections and infestations | rVA576 Coversin | 1 | 15 | 1 |
| other | Lower respiratory tract infection | Infections and infestations | rVA576 Coversin | 1 | 15 | 1 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | rVA576 Coversin | 0 | 15 |
| Total, other adverse events | rVA576 Coversin | 14 | 15 |
| Total, serious adverse events | rVA576 Coversin | 3 | 15 |
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/NCT03829449
GET https://conductscience.org/api/trials/v1/NCT03829449/results?page=2