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TerminatedNCT03829449CONSERVEUpdated Apr 10, 2025Results posted

rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study

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

Why this study was terminated
The early termination of this study is a business decision, Akari have made the decision to close their global Phase III PNH program. The decision was not related to any efficacy, safety or clinical concerns regarding Coversin/rVA576.
Phase
Phase 3
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Long term management of patients with complement related diseases including Paroxysmal Nocturnal Haemoglobinuria and Atypical Haemolytic Uraemic Syndrome

Read the detailed description

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

02

Conditions studied

  • Paroxysmal Nocturnal Hemoglobinuria
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients 18 years and above treated with rVA576 (Coversin) under other Akari clinical trial protocols and wish to remain on rVA576 (Coversin) at the conclusion of that trial.
  2. In the opinion of the treating responsible clinician patient is receiving clinical benefit from continued treatment with study drug.
  3. Evidence of sustained complement inhibition by CH50 assay. .
  4. Women of childbearing potential (WOCBP) must agree to use effective contraception consistently throughout the study and have a negative pregnancy test at screening and a negative urine pregnancy test per the schedule of visits. Women cannot donate their eggs. Women are considered post-menopausal and not of childbearing potential if they have had 12 months of amenorrhea or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks previously.
  5. Males with a childbearing potential partner must agree to use effective contraception consistently OR have had a vasectomy
  6. Weight ≥50-100kg
  7. Willing to receive appropriate prophylaxis against Neisseria meningitidis infection, by both immunisation and continuous or intermittent antibiotics
  8. The patient is willing to give voluntary written informed consent
  9. The patient is willing in the process of preparation and self-administration of the study drug.

Exclusion criteria

Exclusion Criteria:

  1. Patient experienced any safety event in the previous study protocol, which puts the patient at unacceptable risk in current protocol as judged by the investigator and sponsor.
  2. Patient is unwilling to complete the Quality of Life instruments and diary card
  3. Active meningococcal infection (section 4.3.1 for additional information)
  4. Any other reason for which, in the opinion of the Investigator, it would not be in the interests of the patient to remain on rVA576 (Coversin).
  5. If female, the subject is pregnant or lactating or intending to become pregnant before, during, or within 90 days after last dose; or intending to donate ova during such time period.
  6. If male, the subject intends to donate sperm while on the study this study or for 90 days after last dose.
  7. Failure to satisfy the Investigator of fitness to participate for any other reason or any other condition which, in the opinion of the investigator, could increase the subject's risk by participating in the study or confound the outcome of the study.
  8. Use of prohibited medication
  9. The subject has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse.
  10. Participation in other clinical trials with investigational product.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    rVA576 Coversin

    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

Interventions

  • DrugrVA576

    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

05

What researchers measure

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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

  3. 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)

  4. Time to First Transfusion Since Joining the Study.

    Time to first transfusion since joining the study.

    Time frame: approximately 3 years and 5 months

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

06

Results

Posted Mar 12, 2025
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.

Participant flow

Participant flow — Overall Study
MilestonerVA576 Coversin
Started15
Completed13
Not completed2

Outcome measures

PrimaryLong 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)
Reported as:
Count of participants · Participants
Long Term Safety and Efficacy of rVA576 (Coversin) Therapy Assessed by AEs, SAEs, Standard Lab Tests and ECG Results.
ParticipantsrVA576
Adverse Events14
Serious Adverse Events3
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 ECG1
SecondaryProportion 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)
Reported as:
Count of participants · Participants
Proportion of Subjects With Thrombotic and Haemolytic Event Free Status During Each 3month Time Period Since the Start of the Study.
ParticipantsrVA576
Proportion of subjects with thrombotic event free status: 0 - 3 Months15
Proportion of subjects with thrombotic event free status: >3 - 6 Months15
Proportion of subjects with thrombotic event free status: >6 - 9 Months11
Proportion of subjects with thrombotic event free status: >9 - 12 Months10
Proportion of subjects with thrombotic event free status: >12 - 15 Months10
Proportion of subjects with thrombotic event free status: >15 - 18 Months10
Proportion of subjects with thrombotic event free status: >18 - 21 Months8
Proportion of subjects with thrombotic event free status: >21 - 24 Months7
Proportion of subjects with thrombotic event free status: >24 - 27 Months6
Proportion of subjects with thrombotic event free status: >27 - 30 Months6
Proportion of subjects with thrombotic event free status: >30 Months5
Proportion of subjects with haemolytic event free status: 0 - 3 Months13
Proportion of subjects with haemolytic event free status: >3 - 6 Months11
Proportion of subjects with haemolytic event free status: >6 - 9 Months9
Proportion of subjects with haemolytic event free status: >9 - 12 Months9
Proportion of subjects with haemolytic event free status: >12 - 15 Months10
Proportion of subjects with haemolytic event free status: >15 - 18 Months10
Proportion of subjects with haemolytic event free status: >18 - 21 Months8
Proportion of subjects with haemolytic event free status: >21 - 24 Months7
Proportion of subjects with haemolytic event free status: >24 - 27 Months6
Proportion of subjects with haemolytic event free status: >27 - 30 Months6
Proportion of subjects with haemolytic event free status: >30 Months5
SecondaryTime 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
Reported as:
Mean · days since first dose
Time to Thrombotic or Haemolytic Event Since Joining This Study.
days since first doserVA576 Coversin
Time to Thrombotic or Haemolytic Event Since Joining This Study.113.0 ± 80.61
SecondaryProportion 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)
Reported as:
Count of participants · Participants
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
ParticipantsrVA576 Coversin
0 - 3 Months3
>3 - 6 Months2
>6 - 9 Months2
>9 - 12 Months3
>12 - 15 Months3
>15 - 18 Months0
>18 - 21 Months0
>21 - 24 Months1
>24 - 27 Months1
>27 - 30 Months1
>30 Months0
Entire Study4
SecondaryTime to First Transfusion Since Joining the Study.

Time to first transfusion since joining the study.

Time frame:
approximately 3 years and 5 months
Reported as:
Median · days
Time to First Transfusion Since Joining the Study.
daysrVA576 Coversin
Time to First Transfusion Since Joining the Study.30.5 (1 to 284)
SecondaryProportion 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
Reported as:
Count of participants · Participants
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.
ParticipantsrVA576 Coversin
0 - 3 Months - EORTC QLQ-C309
>3 - 6 Months - EORTC QLQ-C308
>6 - 9 Months - EORTC QLQ-C309
>9 - 12 Months - EORTC QLQ-C306
>12 - 15 Months - EORTC QLQ-C300
>15 - 18 Months - EORTC QLQ-C304
>18 - 21 Months - EORTC QLQ-C302
>21 - 24 Months - EORTC QLQ-C305
>24 - 27 Months - EORTC QLQ-C303
>27 - 30 Months - EORTC QLQ-C304
>30 - 33 Months - EORTC QLQ-C302
>33 - 36 Months - EORTC QLQ-C301
>36 - 39 Months - EORTC QLQ-C302
0 - 3 Months - EQ-5D-5L7
>3 - 6 Months - EQ-5D-5L6
>6 - 9 Months - EQ-5D-5L8
>9 - 12 Months - EQ-5D-5L4
>12 - 15 Months - EQ-5D-5L1
>15 - 18 Months - EQ-5D-5L5
>18 - 21 Months - EQ-5D-5L2
>21 - 24 Months - EQ-5D-5L2
>24 - 27 Months - EQ-5D-5L3
>27 - 30 Months - EQ-5D-5L3
>30 - 33 Months - EQ-5D-5L2
>33 - 36 Months - EQ-5D-5L2
>36 - 39 Months - EQ-5D-5L2
0 - 3 Months - FACIT-F0
>3 - 6 Months - FACIT-F1
>6 - 9 Months - FACIT-F0
>9 - 12 Months - FACIT-F0
>12 - 15 Months - FACIT-F0
>15 - 18 Months - FACIT-F0
>18 - 21 Months - FACIT-F0
>21 - 24 Months - FACIT-F0
>24 - 27 Months - FACIT-F0
>27 - 30 Months - FACIT-F0
>30 - 33 Months - FACIT-F0
>33 - 36 Months - FACIT-F0
>36 - 39 Months - FACIT-F0
SecondaryProportion 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
Reported as:
Number · Participants
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.
ParticipantsrVA576
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
SecondaryProportion 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
Reported as:
Number · Participants
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.
ParticipantsrVA576
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
SecondaryProportion 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
Reported as:
Count of participants · Participants
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
ParticipantsrVA576 Coversin
Baseline11
Month 34
Month 64
Month 93
Month 124
Month 150
Month 183
Month 211
Month 243
Month 271
Month 303
Month 331
Month 361
Month 391
SecondaryProportion 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
Reported as:
Count of participants · Participants
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
ParticipantsrVA576 Coversin
Baseline11
Overall Post-Baseline Mean Haemoglobin4
SecondaryProportion 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
Reported as:
Count of participants · Participants
Proportion of Patients Experiencing Major Adverse Vascular Events (MAVE) Over the Entire Period of the Study.
ParticipantsrVA576 Coversin
Proportion of Patients Experiencing Major Adverse Vascular Events (MAVE) Over the Entire Period of the Study.0
SecondaryTime 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

No measurements were reported for this outcome.

SecondaryNumber 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
Reported as:
Number · events
Number of Major Adverse Vascular Events (MAVE) Over the Entire Period of the Study.
eventsrVA576 Coversin
Number of Major Adverse Vascular Events (MAVE) Over the Entire Period of the Study.0

Adverse events

Collected over Approximately 3 years and 5 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
rVA576 Coversin0/15 (0%)3/15 (20%)14/15 (93.3%)
Most frequent serious events
Most frequent serious events
EventrVA576 Coversin
Urinary tract infectionInfections and infestations2/15
VomitingGastrointestinal disorders1/15
Toxicity to various agentsInjury, poisoning and procedural complications1/15
PyrexiaGeneral disorders1/15
Intravascular haemolysisBlood and lymphatic system disorders1/15
Renal failureRenal and urinary disorders1/15
Pulmonary hypertensionRespiratory, thoracic and mediastinal disorders1/15
Musculoskeletal painMusculoskeletal and connective tissue disorders1/15
Fluid overloadMetabolism and nutrition disorders1/15
Angina pectorisCardiac disorders1/15
Most frequent other events
Showing 10 of 44
Most frequent other events
EventrVA576 Coversin
Urinary tract infectionInfections and infestations5/15
PyrexiaGeneral disorders4/15
Upper respiratory tract infectionInfections and infestations3/15
Paroxysmal nocturnal haemoglobinuriaRenal and urinary disorders3/15
DiarrhoeaGastrointestinal disorders3/15
BronchitisInfections and infestations2/15
NasopharyngitisInfections and infestations2/15
Renal failureRenal and urinary disorders2/15
HaemoglobinuriaRenal and urinary disorders2/15
ChromaturiaRenal and urinary disorders2/15

Baseline characteristics

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
Age, Continuous(years)rVA576 Coversin
Median39 (28 to 69)
Sex: Female, Male
Sex: Female, Male(Participants)rVA576 Coversin
Female6
Male9
Race (NIH/OMB)
Race (NIH/OMB)(Participants)rVA576 Coversin
American Indian or Alaska Native0
Asian5
Native Hawaiian or Other Pacific Islander0
Black or African American0
White10
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)rVA576 Coversin
Argentina1
Netherlands1
Poland5
United Kingdom2
Lithuania2
Sri Lanka4
07

Study locations

1 site
  • Instytut Hematologii i Transfuzjologii
    Warsaw, 02-776, Poland
08

References and documents

Study documents

  • Study protocol · Jan 11, 2019
  • Statistical analysis plan · Jan 11, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03829449
Lead sponsor
AKARI Therapeutics
Responsible party
Sponsor
First posted
Feb 4, 2019
Start date
Mar 13, 2017
Primary completion
Aug 29, 2020
Completion
Aug 29, 2020
Results posted
Mar 12, 2025
Last update
Apr 10, 2025

Study contacts

Wynne Weston Davies
study director · AKARI Therapeutics

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
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