Trial · NCT03829449
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Long Term Safety and Efficacy of rVA576 (Coversin) Therapy Assessed by AEs, SAEs, Standard Lab Tests and ECG Results. | On entry and every 3 months thereafter, for the duration of the study (approximately 3 years and 5 months) | To determine the safety profile of long-term rVA576 (Coversin) treatment as assessed by AEs, SAEs, Standard Lab tests and ECG results. |
| Secondary | Proportion of Subjects With Thrombotic and Haemolytic Event Free Status During Each 3month Time Period Since the Start of the Study. | On entry and every 3 months thereafter, for the duration of the study (approximately 3 years and 5 months) | Thrombotic and Haemolytic Events will include, but are not limited to, the following: haemolytic anaemia, thrombocytopenia, red blood cell haemolysis indicated by dark urine, Budd-Chiara syndrome, any other thrombotic or haemolytic event deemed to be associated with PNH. A haemolytic event will be defined as a rise in LDH or other biochemical evidence of haemolysis accompanied by an increase in symptoms and/or frank haemoglobinuria. Increased symptoms without objective haematological or biochemical evidence of haemolysis will not be counted as haemolytic events. In addition, the following signs and symptoms may be reviewed and classified as Thrombotic/Haemolytic events if appropriate: Acute kidney failure, Hypertension, Myocardial infarction, Stroke, Lung complications, Seizure, Coma, Premature death. |
| Secondary | Time to Thrombotic or Haemolytic Event Since Joining This Study. | Approximately 3 years and 5 months | Time to thrombotic or haemolytic event since joining this study. |
| Secondary | Proportion of Subjects Who Require PRBC Transfusion During Each 3-month Period Since the Start of the Study and Over the Entire Period of the Study | On entry and every 3 months thereafter, for the duration of the study (approximately 3 years and 5 months) | Proportion of subjects who require PRBC transfusion during each 3-month period since the start of the study and over the entire period of the study |
| Secondary | Time to First Transfusion Since Joining the Study. | approximately 3 years and 5 months | Time to first transfusion since joining the study. |
| Secondary | Proportion of Subjects With no Adverse Change in Overall Scores of Quality of Life Using the EORTC QLQ-C30, the EQ-5D-5L and FACIT-F Instruments at Each 3-month Time Period Since the Start of the Study. | Every 3 months up to 39 months | Proportion of subjects with no adverse change in overall scores of Quality of Life using the EORTC QLQ-C30, the EQ-5D-5L and FACIT-F instruments at each 3-month time period since the start of the study. |
| Secondary | Proportion of Subjects With Serum Lactate Dehydrogenase (LDH) <1.8, >1.8 to 2.4, >2.4 to 3, and >3 Times the Upper Limit of Normal (ULN) at Each 3-month Time Period Since the Start of the Study. | 12 weeks | Proportion of subjects with serum Lactate Dehydrogenase (LDH) \<1.8, \>1.8 to 2.4, \>2.4 to 3, and \>3 times the upper limit of normal (ULN) at each 3-month time period since the start of the study. |
| Secondary | Proportion of Subjects With Median Serum Lactate Dehydrogenase (LDH) <1.8, >1.8 to 2.4, >2.4 to 3, and >3 Times the Upper Limit of Normal (ULN) Over the Entire Duration of the Study. | Approximately 3 years and 5 months | Proportion of subjects with median serum Lactate Dehydrogenase (LDH) \<1.8, \>1.8 to 2.4, \>2.4 to 3, and \>3 times the upper limit of normal (ULN) over the entire duration of the study. |
| Secondary | Proportion of Transfusion-independent Subjects at Each 3-month Time Point, With Haemoglobin (g/L) Above the Baseline Haemoglobin Value They Had at the Start of the Trial From Which They Entered CONSERVE | Baseline and every 3 months up to 39 months | Proportion of transfusion-independent subjects at each 3-month time point, with haemoglobin (g/L) above the baseline haemoglobin value they had at the start of the trial from which they entered CONSERVE |
| Secondary | Proportion of Transfusion-independent Subjects Over the Entire Duration of the Study With Mean Haemoglobin (g/L) Above the Baseline Haemoglobin Value They Had at the Start of the Trial From Which They Entered CONSERVE | Approximately 3 years and 5 months | Proportion of transfusion-independent subjects over the entire duration of the study with mean haemoglobin (g/L) above the baseline haemoglobin value they had at the start of the trial from which they entered CONSERVE |
| Secondary | Proportion of Patients Experiencing Major Adverse Vascular Events (MAVE) Over the Entire Period of the Study. | Approximately 3 years and 5 months | Proportion of patients experiencing Major Adverse Vascular Events (MAVE) over the entire period of the study. |
| Secondary | Time to First Major Adverse Vascular Event (MAVE) for Each Subject Since Joining the Study. | Approximately 3 years and 5 months | Time to first Major Adverse Vascular Event (MAVE) for each subject since joining the study. |
| Secondary | Number of Major Adverse Vascular Events (MAVE) Over the Entire Period of the Study. | Approximately 3 years and 5 months | Number of Major Adverse Vascular Events (MAVE) over the entire period of the study. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03829449/registered