A Phase 3 interventional study of rVA576 in Paroxysmal Nocturnal Hemoglobinuria, sponsored by AKARI Therapeutics. Terminated at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-10.
Sponsored by AKARI Therapeutics · Phase 3, Interventional, and Treatment
Long term management of patients with complement related diseases including Paroxysmal Nocturnal Haemoglobinuria and Atypical Haemolytic Uraemic Syndrome
Patients with diseases requiring complement inhibition who have previously taken part in Akari clinical trials and who wish to continue to receive rVA576 (Coversin) after their active participation in the parent trial has completed and patients treated under compassionate use or named patient arrangements who wish to continue on rVA576 (Coversin) therapy
191 studies on the registry are indexed under Hemoglobinuria, Paroxysmal; 49 are open to participants now.
This study's enrollment of 15 is below the median of 33 across 150 interventional studies indexed under Hemoglobinuria, Paroxysmal.
Browse Hemoglobinuria, Paroxysmal studies →AKARI Therapeutics is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study population will consist of patients who have completed participation in clinical trials under other Akari protocols and who wish to continue to receive rVA576 (Coversin) for up to 4 years.
Drug: rVA576
The study population will consist of patients who have completed participation in clinical trials under other Akari protocols and who wish to continue to receive rVA576 (Coversin).
Also known as: nomacopan
Long Term Safety and Efficacy of rVA576 (Coversin) Therapy Assessed by AEs, SAEs, Standard Lab Tests and ECG Results.
To determine the safety profile of long-term rVA576 (Coversin) treatment as assessed by AEs, SAEs, Standard Lab tests and ECG results.
Time frame: On entry and every 3 months thereafter, for the duration of the study (approximately 3 years and 5 months)
Proportion of Subjects With Thrombotic and Haemolytic Event Free Status During Each 3month Time Period Since the Start of the Study.
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.
Time frame: On entry and every 3 months thereafter, for the duration of the study (approximately 3 years and 5 months)
Time to Thrombotic or Haemolytic Event Since Joining This Study.
Time to thrombotic or haemolytic event since joining this study.
Time frame: 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
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
Time frame: On entry and every 3 months thereafter, for the duration of the study (approximately 3 years and 5 months)
Time to First Transfusion Since Joining the Study.
Time to first transfusion since joining the study.
Time frame: approximately 3 years and 5 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.
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.
Time frame: Every 3 months up to 39 months
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.
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.
Time frame: 12 weeks
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.
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.
Time frame: Approximately 3 years and 5 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
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
Time frame: Baseline and every 3 months up to 39 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
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
Time frame: Approximately 3 years and 5 months
Proportion of Patients Experiencing Major Adverse Vascular Events (MAVE) Over the Entire Period of the Study.
Proportion of patients experiencing Major Adverse Vascular Events (MAVE) over the entire period of the study.
Time frame: Approximately 3 years and 5 months
Time to First Major Adverse Vascular Event (MAVE) for Each Subject Since Joining the Study.
Time to first Major Adverse Vascular Event (MAVE) for each subject since joining the study.
Time frame: Approximately 3 years and 5 months
Number of Major Adverse Vascular Events (MAVE) Over the Entire Period of the Study.
Number of Major Adverse Vascular Events (MAVE) over the entire period of the study.
Time frame: Approximately 3 years and 5 months
| Milestone | rVA576 Coversin |
|---|---|
| Started | 15 |
| Completed | 13 |
| Not completed | 2 |
To determine the safety profile of long-term rVA576 (Coversin) treatment as assessed by AEs, SAEs, Standard Lab tests and ECG results.
| Participants | rVA576 |
|---|---|
| Adverse Events | 14 |
| Serious Adverse Events | 3 |
| Clinically significant hemoglobin (low) | 7 |
| Clinically significant hematocrit (low) | 6 |
| Clinically significant MCH (high) | 4 |
| Clinically significant MCV (high) | 3 |
| Clinically significant RBC (low) | 6 |
| Clinically significant reticulocytes (high) | 4 |
| Clinically significant basophils (low) | 1 |
| Clinically significant eosinophils (low) | 1 |
| Clinically significant neutrophils (low) | 1 |
| Clinically significant platelets (low) | 1 |
| Clinically significant reticulocytes (low) | 2 |
| Clinically significant WBC (low) | 1 |
| Clinically significant ALT (high) | 3 |
| Clinically significant AST (high) | 6 |
| Clinically significant creatine kinase (high) | 2 |
| Clinically significant creatinine (high) | 6 |
| Clinically significant direct bilirubin (high) | 5 |
| Clinically significant total bilirubin (high) | 7 |
| Clinically significant gamma glutamyl transpeptidase (GGT) (high) | 2 |
| Clinically significant LDH (high) | 10 |
| Clinically significant potassium (high) | 1 |
| Clinically significant urea (high) | 2 |
| Clinically significant potassium (low) | 1 |
| Clinically significant ECG | 1 |
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.
| Participants | rVA576 |
|---|---|
| Proportion of subjects with thrombotic event free status: 0 - 3 Months | 15 |
| Proportion of subjects with thrombotic event free status: >3 - 6 Months | 15 |
| Proportion of subjects with thrombotic event free status: >6 - 9 Months | 11 |
| Proportion of subjects with thrombotic event free status: >9 - 12 Months | 10 |
| Proportion of subjects with thrombotic event free status: >12 - 15 Months | 10 |
| Proportion of subjects with thrombotic event free status: >15 - 18 Months | 10 |
| Proportion of subjects with thrombotic event free status: >18 - 21 Months | 8 |
| Proportion of subjects with thrombotic event free status: >21 - 24 Months | 7 |
| Proportion of subjects with thrombotic event free status: >24 - 27 Months | 6 |
| Proportion of subjects with thrombotic event free status: >27 - 30 Months | 6 |
| Proportion of subjects with thrombotic event free status: >30 Months | 5 |
| Proportion of subjects with haemolytic event free status: 0 - 3 Months | 13 |
| Proportion of subjects with haemolytic event free status: >3 - 6 Months | 11 |
| Proportion of subjects with haemolytic event free status: >6 - 9 Months | 9 |
| Proportion of subjects with haemolytic event free status: >9 - 12 Months | 9 |
| Proportion of subjects with haemolytic event free status: >12 - 15 Months | 10 |
| Proportion of subjects with haemolytic event free status: >15 - 18 Months | 10 |
| Proportion of subjects with haemolytic event free status: >18 - 21 Months | 8 |
| Proportion of subjects with haemolytic event free status: >21 - 24 Months | 7 |
| Proportion of subjects with haemolytic event free status: >24 - 27 Months | 6 |
| Proportion of subjects with haemolytic event free status: >27 - 30 Months | 6 |
| Proportion of subjects with haemolytic event free status: >30 Months | 5 |
Time to thrombotic or haemolytic event since joining this study.
| days since first dose | rVA576 Coversin |
|---|---|
| Time to Thrombotic or Haemolytic Event Since Joining This Study. | 113.0 ± 80.61 |
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
| Participants | rVA576 Coversin |
|---|---|
| 0 - 3 Months | 3 |
| >3 - 6 Months | 2 |
| >6 - 9 Months | 2 |
| >9 - 12 Months | 3 |
| >12 - 15 Months | 3 |
| >15 - 18 Months | 0 |
| >18 - 21 Months | 0 |
| >21 - 24 Months | 1 |
| >24 - 27 Months | 1 |
| >27 - 30 Months | 1 |
| >30 Months | 0 |
| Entire Study | 4 |
Time to first transfusion since joining the study.
| days | rVA576 Coversin |
|---|---|
| Time to First Transfusion Since Joining the Study. | 30.5 (1 to 284) |
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.
| Participants | rVA576 Coversin |
|---|---|
| 0 - 3 Months - EORTC QLQ-C30 | 9 |
| >3 - 6 Months - EORTC QLQ-C30 | 8 |
| >6 - 9 Months - EORTC QLQ-C30 | 9 |
| >9 - 12 Months - EORTC QLQ-C30 | 6 |
| >12 - 15 Months - EORTC QLQ-C30 | 0 |
| >15 - 18 Months - EORTC QLQ-C30 | 4 |
| >18 - 21 Months - EORTC QLQ-C30 | 2 |
| >21 - 24 Months - EORTC QLQ-C30 | 5 |
| >24 - 27 Months - EORTC QLQ-C30 | 3 |
| >27 - 30 Months - EORTC QLQ-C30 | 4 |
| >30 - 33 Months - EORTC QLQ-C30 | 2 |
| >33 - 36 Months - EORTC QLQ-C30 | 1 |
| >36 - 39 Months - EORTC QLQ-C30 | 2 |
| 0 - 3 Months - EQ-5D-5L | 7 |
| >3 - 6 Months - EQ-5D-5L | 6 |
| >6 - 9 Months - EQ-5D-5L | 8 |
| >9 - 12 Months - EQ-5D-5L | 4 |
| >12 - 15 Months - EQ-5D-5L | 1 |
| >15 - 18 Months - EQ-5D-5L | 5 |
| >18 - 21 Months - EQ-5D-5L | 2 |
| >21 - 24 Months - EQ-5D-5L | 2 |
| >24 - 27 Months - EQ-5D-5L | 3 |
| >27 - 30 Months - EQ-5D-5L | 3 |
| >30 - 33 Months - EQ-5D-5L | 2 |
| >33 - 36 Months - EQ-5D-5L | 2 |
| >36 - 39 Months - EQ-5D-5L | 2 |
| 0 - 3 Months - FACIT-F | 0 |
| >3 - 6 Months - FACIT-F | 1 |
| >6 - 9 Months - FACIT-F | 0 |
| >9 - 12 Months - FACIT-F | 0 |
| >12 - 15 Months - FACIT-F | 0 |
| >15 - 18 Months - FACIT-F | 0 |
| >18 - 21 Months - FACIT-F | 0 |
| >21 - 24 Months - FACIT-F | 0 |
| >24 - 27 Months - FACIT-F | 0 |
| >27 - 30 Months - FACIT-F | 0 |
| >30 - 33 Months - FACIT-F | 0 |
| >33 - 36 Months - FACIT-F | 0 |
| >36 - 39 Months - FACIT-F | 0 |
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.
| Participants | rVA576 |
|---|---|
| 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. | 3 |
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.
| Participants | rVA576 |
|---|---|
| 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. | 4 |
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
| Participants | rVA576 Coversin |
|---|---|
| Baseline | 11 |
| Month 3 | 4 |
| Month 6 | 4 |
| Month 9 | 3 |
| Month 12 | 4 |
| Month 15 | 0 |
| Month 18 | 3 |
| Month 21 | 1 |
| Month 24 | 3 |
| Month 27 | 1 |
| Month 30 | 3 |
| Month 33 | 1 |
| Month 36 | 1 |
| Month 39 | 1 |
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
| Participants | rVA576 Coversin |
|---|---|
| Baseline | 11 |
| Overall Post-Baseline Mean Haemoglobin | 4 |
Proportion of patients experiencing Major Adverse Vascular Events (MAVE) over the entire period of the study.
| Participants | rVA576 Coversin |
|---|---|
| Proportion of Patients Experiencing Major Adverse Vascular Events (MAVE) Over the Entire Period of the Study. | 0 |
Time to first Major Adverse Vascular Event (MAVE) for each subject since joining the study.
No measurements were reported for this outcome.
Number of Major Adverse Vascular Events (MAVE) over the entire period of the study.
| events | rVA576 Coversin |
|---|---|
| Number of Major Adverse Vascular Events (MAVE) Over the Entire Period of the Study. | 0 |
Collected over Approximately 3 years and 5 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| rVA576 Coversin | 0/15 (0%) | 3/15 (20%) | 14/15 (93.3%) |
| Event | rVA576 Coversin |
|---|---|
| Urinary tract infectionInfections and infestations | 2/15 |
| VomitingGastrointestinal disorders | 1/15 |
| Toxicity to various agentsInjury, poisoning and procedural complications | 1/15 |
| PyrexiaGeneral disorders | 1/15 |
| Intravascular haemolysisBlood and lymphatic system disorders | 1/15 |
| Renal failureRenal and urinary disorders | 1/15 |
| Pulmonary hypertensionRespiratory, thoracic and mediastinal disorders | 1/15 |
| Musculoskeletal painMusculoskeletal and connective tissue disorders | 1/15 |
| Fluid overloadMetabolism and nutrition disorders | 1/15 |
| Angina pectorisCardiac disorders | 1/15 |
| Event | rVA576 Coversin |
|---|---|
| Urinary tract infectionInfections and infestations | 5/15 |
| PyrexiaGeneral disorders | 4/15 |
| Upper respiratory tract infectionInfections and infestations | 3/15 |
| Paroxysmal nocturnal haemoglobinuriaRenal and urinary disorders | 3/15 |
| DiarrhoeaGastrointestinal disorders | 3/15 |
| BronchitisInfections and infestations | 2/15 |
| NasopharyngitisInfections and infestations | 2/15 |
| Renal failureRenal and urinary disorders | 2/15 |
| HaemoglobinuriaRenal and urinary disorders | 2/15 |
| ChromaturiaRenal and urinary disorders | 2/15 |
The primary analysis was intention to treat (ITT) and all patients who entered and who signed the ICF were included in the Full Analysis Set.
| Age, Continuous(years) | rVA576 Coversin |
|---|---|
| Median | 39 (28 to 69) |
| Sex: Female, Male(Participants) | rVA576 Coversin |
|---|---|
| Female | 6 |
| Male | 9 |
| Race (NIH/OMB)(Participants) | rVA576 Coversin |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 5 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 10 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | rVA576 Coversin |
|---|---|
| Argentina | 1 |
| Netherlands | 1 |
| Poland | 5 |
| United Kingdom | 2 |
| Lithuania | 2 |
| Sri Lanka | 4 |
PDFs hosted by the registry, ClinicalTrials.gov.
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This study is terminated, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: RVA576
AKARI Therapeutics