Trial Outcomes & Findings for rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study (NCT NCT03829449)
NCT ID: NCT03829449
Last Updated: 2025-04-10
Results Overview
To determine the safety profile of long-term rVA576 (Coversin) treatment as assessed by AEs, SAEs, Standard Lab tests and ECG results.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
15 participants
Primary outcome timeframe
On entry and every 3 months thereafter, for the duration of the study (approximately 3 years and 5 months)
Results posted on
2025-04-10
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study
Baseline characteristics by cohort
| Measure |
rVA576 Coversin
n=15 Participants
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 for up to 4 years.
|
|---|---|
|
Age, Continuous
|
39 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
5 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Lithuania
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Sri Lanka
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
rVA576
n=15 Participants
rVA576: The study population will consist of patients who have completed participation in clinical trials under other sponsor protocols and who wish to continue to receive rVA576 in open label single arm
|
|---|---|
|
Long Term Safety and Efficacy of rVA576 (Coversin) Therapy Assessed by AEs, SAEs, Standard Lab Tests and ECG Results.
Adverse Events
|
14 Participants
|
|
Long Term Safety and Efficacy of rVA576 (Coversin) Therapy Assessed by AEs, SAEs, Standard Lab Tests and ECG Results.
Serious Adverse Events
|
3 Participants
|
|
Long Term Safety and Efficacy of rVA576 (Coversin) Therapy Assessed by AEs, SAEs, Standard Lab Tests and ECG Results.
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.
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.
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.
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.
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.
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.
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.
Clinically significant eosinophils (low)
|
1 Participants
|
|
Long Term Safety and Efficacy of rVA576 (Coversin) Therapy Assessed by AEs, SAEs, Standard Lab Tests and ECG Results.
Clinically significant neutrophils (low)
|
1 Participants
|
|
Long Term Safety and Efficacy of rVA576 (Coversin) Therapy Assessed by AEs, SAEs, Standard Lab Tests and ECG Results.
Clinically significant platelets (low)
|
1 Participants
|
|
Long Term Safety and Efficacy of rVA576 (Coversin) Therapy Assessed by AEs, SAEs, Standard Lab Tests and ECG Results.
Clinically significant reticulocytes (low)
|
2 Participants
|
|
Long Term Safety and Efficacy of rVA576 (Coversin) Therapy Assessed by AEs, SAEs, Standard Lab Tests and ECG Results.
Clinically significant WBC (low)
|
1 Participants
|
|
Long Term Safety and Efficacy of rVA576 (Coversin) Therapy Assessed by AEs, SAEs, Standard Lab Tests and ECG Results.
Clinically significant ALT (high)
|
3 Participants
|
|
Long Term Safety and Efficacy of rVA576 (Coversin) Therapy Assessed by AEs, SAEs, Standard Lab Tests and ECG Results.
Clinically significant AST (high)
|
6 Participants
|
|
Long Term Safety and Efficacy of rVA576 (Coversin) Therapy Assessed by AEs, SAEs, Standard Lab Tests and ECG Results.
Clinically significant creatine kinase (high)
|
2 Participants
|
|
Long Term Safety and Efficacy of rVA576 (Coversin) Therapy Assessed by AEs, SAEs, Standard Lab Tests and ECG Results.
Clinically significant creatinine (high)
|
6 Participants
|
|
Long Term Safety and Efficacy of rVA576 (Coversin) Therapy Assessed by AEs, SAEs, Standard Lab Tests and ECG Results.
Clinically significant direct bilirubin (high)
|
5 Participants
|
|
Long Term Safety and Efficacy of rVA576 (Coversin) Therapy Assessed by AEs, SAEs, Standard Lab Tests and ECG Results.
Clinically significant total bilirubin (high)
|
7 Participants
|
|
Long Term Safety and Efficacy of rVA576 (Coversin) Therapy Assessed by AEs, SAEs, Standard Lab Tests and ECG Results.
Clinically significant gamma glutamyl transpeptidase (GGT) (high)
|
2 Participants
|
|
Long Term Safety and Efficacy of rVA576 (Coversin) Therapy Assessed by AEs, SAEs, Standard Lab Tests and ECG Results.
Clinically significant LDH (high)
|
10 Participants
|
|
Long Term Safety and Efficacy of rVA576 (Coversin) Therapy Assessed by AEs, SAEs, Standard Lab Tests and ECG Results.
Clinically significant potassium (high)
|
1 Participants
|
|
Long Term Safety and Efficacy of rVA576 (Coversin) Therapy Assessed by AEs, SAEs, Standard Lab Tests and ECG Results.
Clinically significant urea (high)
|
2 Participants
|
|
Long Term Safety and Efficacy of rVA576 (Coversin) Therapy Assessed by AEs, SAEs, Standard Lab Tests and ECG Results.
Clinically significant potassium (low)
|
1 Participants
|
|
Long Term Safety and Efficacy of rVA576 (Coversin) Therapy Assessed by AEs, SAEs, Standard Lab Tests and ECG Results.
Clinically significant ECG
|
1 Participants
|
SECONDARY outcome
Timeframe: On entry and every 3 months thereafter, for the duration of the study (approximately 3 years and 5 months)Population: 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.
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.
Outcome measures
| Measure |
rVA576
n=15 Participants
rVA576: The study population will consist of patients who have completed participation in clinical trials under other sponsor protocols and who wish to continue to receive rVA576 in open label single arm
|
|---|---|
|
Proportion of Subjects With Thrombotic and Haemolytic Event Free Status During Each 3month Time Period Since the Start of the Study.
Proportion of subjects with thrombotic event free status: 0 - 3 Months
|
15 Participants
|
|
Proportion of Subjects With Thrombotic and Haemolytic Event Free Status During Each 3month Time Period Since the Start of the Study.
Proportion of subjects with thrombotic event free status: >3 - 6 Months
|
15 Participants
|
|
Proportion of Subjects With Thrombotic and Haemolytic Event Free Status During Each 3month Time Period Since the Start of the Study.
Proportion of subjects with thrombotic event free status: >6 - 9 Months
|
11 Participants
|
|
Proportion of Subjects With Thrombotic and Haemolytic Event Free Status During Each 3month Time Period Since the Start of the Study.
Proportion of subjects with thrombotic event free status: >9 - 12 Months
|
10 Participants
|
|
Proportion of Subjects With Thrombotic and Haemolytic Event Free Status During Each 3month Time Period Since the Start of the Study.
Proportion of subjects with thrombotic event free status: >12 - 15 Months
|
10 Participants
|
|
Proportion of Subjects With Thrombotic and Haemolytic Event Free Status During Each 3month Time Period Since the Start of the Study.
Proportion of subjects with thrombotic event free status: >15 - 18 Months
|
10 Participants
|
|
Proportion of Subjects With Thrombotic and Haemolytic Event Free Status During Each 3month Time Period Since the Start of the Study.
Proportion of subjects with thrombotic event free status: >18 - 21 Months
|
8 Participants
|
|
Proportion of Subjects With Thrombotic and Haemolytic Event Free Status During Each 3month Time Period Since the Start of the Study.
Proportion of subjects with thrombotic event free status: >21 - 24 Months
|
7 Participants
|
|
Proportion of Subjects With Thrombotic and Haemolytic Event Free Status During Each 3month Time Period Since the Start of the Study.
Proportion of subjects with thrombotic event free status: >24 - 27 Months
|
6 Participants
|
|
Proportion of Subjects With Thrombotic and Haemolytic Event Free Status During Each 3month Time Period Since the Start of the Study.
Proportion of subjects with thrombotic event free status: >27 - 30 Months
|
6 Participants
|
|
Proportion of Subjects With Thrombotic and Haemolytic Event Free Status During Each 3month Time Period Since the Start of the Study.
Proportion of subjects with thrombotic event free status: >30 Months
|
5 Participants
|
|
Proportion of Subjects With Thrombotic and Haemolytic Event Free Status During Each 3month Time Period Since the Start of the Study.
Proportion of subjects with haemolytic event free status: 0 - 3 Months
|
13 Participants
|
|
Proportion of Subjects With Thrombotic and Haemolytic Event Free Status During Each 3month Time Period Since the Start of the Study.
Proportion of subjects with haemolytic event free status: >3 - 6 Months
|
11 Participants
|
|
Proportion of Subjects With Thrombotic and Haemolytic Event Free Status During Each 3month Time Period Since the Start of the Study.
Proportion of subjects with haemolytic event free status: >6 - 9 Months
|
9 Participants
|
|
Proportion of Subjects With Thrombotic and Haemolytic Event Free Status During Each 3month Time Period Since the Start of the Study.
Proportion of subjects with haemolytic event free status: >9 - 12 Months
|
9 Participants
|
|
Proportion of Subjects With Thrombotic and Haemolytic Event Free Status During Each 3month Time Period Since the Start of the Study.
Proportion of subjects with haemolytic event free status: >12 - 15 Months
|
10 Participants
|
|
Proportion of Subjects With Thrombotic and Haemolytic Event Free Status During Each 3month Time Period Since the Start of the Study.
Proportion of subjects with haemolytic event free status: >15 - 18 Months
|
10 Participants
|
|
Proportion of Subjects With Thrombotic and Haemolytic Event Free Status During Each 3month Time Period Since the Start of the Study.
Proportion of subjects with haemolytic event free status: >18 - 21 Months
|
8 Participants
|
|
Proportion of Subjects With Thrombotic and Haemolytic Event Free Status During Each 3month Time Period Since the Start of the Study.
Proportion of subjects with haemolytic event free status: >21 - 24 Months
|
7 Participants
|
|
Proportion of Subjects With Thrombotic and Haemolytic Event Free Status During Each 3month Time Period Since the Start of the Study.
Proportion of subjects with haemolytic event free status: >24 - 27 Months
|
6 Participants
|
|
Proportion of Subjects With Thrombotic and Haemolytic Event Free Status During Each 3month Time Period Since the Start of the Study.
Proportion of subjects with haemolytic event free status: >27 - 30 Months
|
6 Participants
|
|
Proportion of Subjects With Thrombotic and Haemolytic Event Free Status During Each 3month Time Period Since the Start of the Study.
Proportion of subjects with haemolytic event free status: >30 Months
|
5 Participants
|
SECONDARY outcome
Timeframe: Approximately 3 years and 5 monthsTime to thrombotic or haemolytic event since joining this study.
Outcome measures
| Measure |
rVA576
n=14 Participants
rVA576: The study population will consist of patients who have completed participation in clinical trials under other sponsor protocols and who wish to continue to receive rVA576 in open label single arm
|
|---|---|
|
Time to Thrombotic or Haemolytic Event Since Joining This Study.
|
113.0 days since first dose
Standard Deviation 80.61
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
rVA576
n=15 Participants
rVA576: The study population will consist of patients who have completed participation in clinical trials under other sponsor protocols and who wish to continue to receive rVA576 in open label single arm
|
|---|---|
|
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
0 - 3 Months
|
3 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
>3 - 6 Months
|
2 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
>6 - 9 Months
|
2 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
>9 - 12 Months
|
3 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
>12 - 15 Months
|
3 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
>15 - 18 Months
|
0 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
>18 - 21 Months
|
0 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
>21 - 24 Months
|
1 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
>24 - 27 Months
|
1 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
>27 - 30 Months
|
1 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
>30 Months
|
0 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
Entire Study
|
4 Participants
|
SECONDARY outcome
Timeframe: approximately 3 years and 5 monthsTime to first transfusion since joining the study.
Outcome measures
| Measure |
rVA576
n=15 Participants
rVA576: The study population will consist of patients who have completed participation in clinical trials under other sponsor protocols and who wish to continue to receive rVA576 in open label single arm
|
|---|---|
|
Time to First Transfusion Since Joining the Study.
|
30.5 days
Interval 1.0 to 284.0
|
SECONDARY outcome
Timeframe: Every 3 months up to 39 monthsPopulation: Not all participants completed the self-reported questionnaires at all timepoints
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.
Outcome measures
| Measure |
rVA576
n=15 Participants
rVA576: The study population will consist of patients who have completed participation in clinical trials under other sponsor protocols and who wish to continue to receive rVA576 in open label single arm
|
|---|---|
|
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.
0 - 3 Months - EORTC QLQ-C30
|
9 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.
>3 - 6 Months - EORTC QLQ-C30
|
8 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.
>6 - 9 Months - EORTC QLQ-C30
|
9 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.
>9 - 12 Months - EORTC QLQ-C30
|
6 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.
>12 - 15 Months - EORTC QLQ-C30
|
0 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.
>15 - 18 Months - EORTC QLQ-C30
|
4 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.
>18 - 21 Months - EORTC QLQ-C30
|
2 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.
>21 - 24 Months - EORTC QLQ-C30
|
5 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.
>24 - 27 Months - EORTC QLQ-C30
|
3 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.
>27 - 30 Months - EORTC QLQ-C30
|
4 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.
>30 - 33 Months - EORTC QLQ-C30
|
2 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.
>33 - 36 Months - EORTC QLQ-C30
|
1 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.
>36 - 39 Months - EORTC QLQ-C30
|
2 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.
0 - 3 Months - EQ-5D-5L
|
7 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.
>3 - 6 Months - EQ-5D-5L
|
6 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.
>6 - 9 Months - EQ-5D-5L
|
8 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.
>9 - 12 Months - EQ-5D-5L
|
4 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.
>12 - 15 Months - EQ-5D-5L
|
1 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.
>15 - 18 Months - EQ-5D-5L
|
5 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.
>18 - 21 Months - EQ-5D-5L
|
2 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.
>21 - 24 Months - EQ-5D-5L
|
2 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.
>24 - 27 Months - EQ-5D-5L
|
3 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.
>27 - 30 Months - EQ-5D-5L
|
3 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.
>30 - 33 Months - EQ-5D-5L
|
2 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.
>33 - 36 Months - EQ-5D-5L
|
2 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.
>36 - 39 Months - EQ-5D-5L
|
2 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.
0 - 3 Months - FACIT-F
|
0 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.
>3 - 6 Months - FACIT-F
|
1 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.
>6 - 9 Months - FACIT-F
|
0 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.
>9 - 12 Months - FACIT-F
|
0 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.
>12 - 15 Months - FACIT-F
|
0 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.
>15 - 18 Months - FACIT-F
|
0 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.
>18 - 21 Months - FACIT-F
|
0 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.
>21 - 24 Months - FACIT-F
|
0 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.
>24 - 27 Months - FACIT-F
|
0 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.
>27 - 30 Months - FACIT-F
|
0 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.
>30 - 33 Months - FACIT-F
|
0 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.
>33 - 36 Months - FACIT-F
|
0 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.
>36 - 39 Months - FACIT-F
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 weeksProportion 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.
Outcome measures
| Measure |
rVA576
n=15 Participants
rVA576: The study population will consist of patients who have completed participation in clinical trials under other sponsor protocols and who wish to continue to receive rVA576 in open label single arm
|
|---|---|
|
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 Participants
|
SECONDARY outcome
Timeframe: Approximately 3 years and 5 monthsProportion 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.
Outcome measures
| Measure |
rVA576
n=15 Participants
rVA576: The study population will consist of patients who have completed participation in clinical trials under other sponsor protocols and who wish to continue to receive rVA576 in open label single arm
|
|---|---|
|
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 Participants
|
SECONDARY outcome
Timeframe: Baseline and every 3 months up to 39 monthsPopulation: Total number of subjects analyzed at each timepoint is specified.
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
Outcome measures
| Measure |
rVA576
n=11 Participants
rVA576: The study population will consist of patients who have completed participation in clinical trials under other sponsor protocols and who wish to continue to receive rVA576 in open label single arm
|
|---|---|
|
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
|
11 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
Month 3
|
4 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
Month 6
|
4 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
Month 9
|
3 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
Month 12
|
4 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
Month 15
|
0 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
Month 18
|
3 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
Month 21
|
1 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
Month 24
|
3 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
Month 27
|
1 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
Month 30
|
3 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
Month 33
|
1 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
Month 36
|
1 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
Month 39
|
1 Participants
|
SECONDARY outcome
Timeframe: Approximately 3 years and 5 monthsPopulation: Total number of subjects analyzed with post-baseline values is specified.
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
Outcome measures
| Measure |
rVA576
n=11 Participants
rVA576: The study population will consist of patients who have completed participation in clinical trials under other sponsor protocols and who wish to continue to receive rVA576 in open label single arm
|
|---|---|
|
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
Baseline
|
11 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
Overall Post-Baseline Mean Haemoglobin
|
4 Participants
|
SECONDARY outcome
Timeframe: Approximately 3 years and 5 monthsProportion of patients experiencing Major Adverse Vascular Events (MAVE) over the entire period of the study.
Outcome measures
| Measure |
rVA576
n=15 Participants
rVA576: The study population will consist of patients who have completed participation in clinical trials under other sponsor protocols and who wish to continue to receive rVA576 in open label single arm
|
|---|---|
|
Proportion of Patients Experiencing Major Adverse Vascular Events (MAVE) Over the Entire Period of the Study.
|
0 Participants
|
SECONDARY outcome
Timeframe: Approximately 3 years and 5 monthsPopulation: There were no Major Adverse Vascular Events (MAVEs) reported during the entire period of the study.
Time to first Major Adverse Vascular Event (MAVE) for each subject since joining the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 3 years and 5 monthsNumber of Major Adverse Vascular Events (MAVE) over the entire period of the study.
Outcome measures
| Measure |
rVA576
n=15 Participants
rVA576: The study population will consist of patients who have completed participation in clinical trials under other sponsor protocols and who wish to continue to receive rVA576 in open label single arm
|
|---|---|
|
Number of Major Adverse Vascular Events (MAVE) Over the Entire Period of the Study.
|
0 events
|
Adverse Events
rVA576 Coversin
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
rVA576 Coversin
n=15 participants at risk
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.
|
|---|---|
|
Infections and infestations
Urinary tract infection
|
13.3%
2/15 • Number of events 2 • Approximately 3 years and 5 months
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Number of events 1 • Approximately 3 years and 5 months
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
6.7%
1/15 • Number of events 1 • Approximately 3 years and 5 months
|
|
General disorders
Pyrexia
|
6.7%
1/15 • Number of events 1 • Approximately 3 years and 5 months
|
|
Blood and lymphatic system disorders
Intravascular haemolysis
|
6.7%
1/15 • Number of events 1 • Approximately 3 years and 5 months
|
|
Renal and urinary disorders
Renal failure
|
6.7%
1/15 • Number of events 2 • Approximately 3 years and 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
6.7%
1/15 • Number of events 1 • Approximately 3 years and 5 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.7%
1/15 • Number of events 1 • Approximately 3 years and 5 months
|
|
Metabolism and nutrition disorders
Fluid overload
|
6.7%
1/15 • Number of events 1 • Approximately 3 years and 5 months
|
|
Cardiac disorders
Angina pectoris
|
6.7%
1/15 • Number of events 2 • Approximately 3 years and 5 months
|
Other adverse events
| Measure |
rVA576 Coversin
n=15 participants at risk
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.
|
|---|---|
|
Infections and infestations
Urinary tract infection
|
33.3%
5/15 • Number of events 8 • Approximately 3 years and 5 months
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
3/15 • Number of events 3 • Approximately 3 years and 5 months
|
|
Infections and infestations
Bronchitis
|
13.3%
2/15 • Number of events 4 • Approximately 3 years and 5 months
|
|
Infections and infestations
Nasopharyngitis
|
13.3%
2/15 • Number of events 2 • Approximately 3 years and 5 months
|
|
Infections and infestations
Cystitis
|
6.7%
1/15 • Number of events 1 • Approximately 3 years and 5 months
|
|
Infections and infestations
Rhinitis
|
6.7%
1/15 • Number of events 1 • Approximately 3 years and 5 months
|
|
Infections and infestations
Respiratory tract infection viral
|
6.7%
1/15 • Number of events 1 • Approximately 3 years and 5 months
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15 • Number of events 1 • Approximately 3 years and 5 months
|
|
Infections and infestations
Pharyngitis
|
6.7%
1/15 • Number of events 1 • Approximately 3 years and 5 months
|
|
Infections and infestations
Lower respiratory tract infection
|
6.7%
1/15 • Number of events 1 • Approximately 3 years and 5 months
|
|
Infections and infestations
Vulvovaginal candidiasis
|
6.7%
1/15 • Number of events 1 • Approximately 3 years and 5 months
|
|
Renal and urinary disorders
Paroxysmal nocturnal haemoglobinuria
|
20.0%
3/15 • Number of events 8 • Approximately 3 years and 5 months
|
|
Renal and urinary disorders
Renal failure
|
13.3%
2/15 • Number of events 3 • Approximately 3 years and 5 months
|
|
Renal and urinary disorders
Haemoglobinuria
|
13.3%
2/15 • Number of events 5 • Approximately 3 years and 5 months
|
|
Renal and urinary disorders
Chromaturia
|
13.3%
2/15 • Number of events 5 • Approximately 3 years and 5 months
|
|
Renal and urinary disorders
Dysuria
|
13.3%
2/15 • Number of events 2 • Approximately 3 years and 5 months
|
|
Renal and urinary disorders
Calculus urinary
|
6.7%
1/15 • Number of events 1 • Approximately 3 years and 5 months
|
|
Renal and urinary disorders
Renal colic
|
6.7%
1/15 • Number of events 1 • Approximately 3 years and 5 months
|
|
Renal and urinary disorders
Renal impairment
|
6.7%
1/15 • Number of events 1 • Approximately 3 years and 5 months
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
3/15 • Number of events 4 • Approximately 3 years and 5 months
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
2/15 • Number of events 3 • Approximately 3 years and 5 months
|
|
Gastrointestinal disorders
Abdominal pain
|
13.3%
2/15 • Number of events 2 • Approximately 3 years and 5 months
|
|
Gastrointestinal disorders
Nausea
|
13.3%
2/15 • Number of events 2 • Approximately 3 years and 5 months
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
1/15 • Number of events 1 • Approximately 3 years and 5 months
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.7%
1/15 • Number of events 1 • Approximately 3 years and 5 months
|
|
Gastrointestinal disorders
Flatulence
|
6.7%
1/15 • Number of events 1 • Approximately 3 years and 5 months
|
|
Gastrointestinal disorders
Toothache
|
6.7%
1/15 • Number of events 1 • Approximately 3 years and 5 months
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • Number of events 1 • Approximately 3 years and 5 months
|
|
Gastrointestinal disorders
Abdominal distension
|
6.7%
1/15 • Number of events 1 • Approximately 3 years and 5 months
|
|
Gastrointestinal disorders
Ascites
|
6.7%
1/15 • Number of events 1 • Approximately 3 years and 5 months
|
|
General disorders
Pyrexia
|
26.7%
4/15 • Number of events 5 • Approximately 3 years and 5 months
|
|
General disorders
Influenza like illness
|
6.7%
1/15 • Number of events 3 • Approximately 3 years and 5 months
|
|
General disorders
Fatigue
|
13.3%
2/15 • Number of events 2 • Approximately 3 years and 5 months
|
|
General disorders
Injection site pain
|
6.7%
1/15 • Number of events 2 • Approximately 3 years and 5 months
|
|
General disorders
Injection site pruritus
|
6.7%
1/15 • Number of events 1 • Approximately 3 years and 5 months
|
|
General disorders
Injection site swelling
|
6.7%
1/15 • Number of events 1 • Approximately 3 years and 5 months
|
|
Investigations
Urinary casts
|
13.3%
2/15 • Number of events 2 • Approximately 3 years and 5 months
|
|
Investigations
White blood cells urine positive
|
13.3%
2/15 • Number of events 2 • Approximately 3 years and 5 months
|
|
Investigations
Blood LDH increased
|
6.7%
1/15 • Number of events 1 • Approximately 3 years and 5 months
|
|
Investigations
Creatinine renal clearance decreased
|
6.7%
1/15 • Number of events 1 • Approximately 3 years and 5 months
|
|
Investigations
WBC decreased
|
6.7%
1/15 • Number of events 1 • Approximately 3 years and 5 months
|
|
Investigations
Glucose urine present
|
6.7%
1/15 • Number of events 1 • Approximately 3 years and 5 months
|
|
Investigations
Neutrophil count decreased
|
6.7%
1/15 • Number of events 1 • Approximately 3 years and 5 months
|
|
Investigations
Liver function test abnormal
|
6.7%
1/15 • Number of events 1 • Approximately 3 years and 5 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place