Trial · NCT03829449
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Long Term Safety and Efficacy of rVA576 (Coversin) Therapy Assessed by AEs, SAEs, Standard Lab Tests and ECG Results. | On entry and every 3 months thereafter, for the duration of the study (approximately 3 years and 5 months) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of Subjects With Thrombotic and Haemolytic Event Free Status During Each 3month Time Period Since the Start of the Study. | On entry and every 3 months thereafter, for the duration of the study (approximately 3 years and 5 months) | Data are not available for all 15 participants at every 3-month interval due to the early termination of the trial. The proportion of subjects with thrombotic or haemolytic event free status in each 3-month interval is calculated based on the actual number of participants analysed at each 3-month interval. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Thrombotic or Haemolytic Event Since Joining This Study. | Approximately 3 years and 5 months | days since first dose | MEAN | |
| SECONDARY | Proportion of Subjects Who Require PRBC Transfusion During Each 3-month Period Since the Start of the Study and Over the Entire Period of the Study | On entry and every 3 months thereafter, for the duration of the study (approximately 3 years and 5 months) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to First Transfusion Since Joining the Study. | approximately 3 years and 5 months | days | MEDIAN | |
| SECONDARY | Proportion of Subjects With no Adverse Change in Overall Scores of Quality of Life Using the EORTC QLQ-C30, the EQ-5D-5L and FACIT-F Instruments at Each 3-month Time Period Since the Start of the Study. | Every 3 months up to 39 months | Not all participants completed the self-reported questionnaires at all timepoints | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Subjects With Serum Lactate Dehydrogenase (LDH) <1.8, >1.8 to 2.4, >2.4 to 3, and >3 Times the Upper Limit of Normal (ULN) at Each 3-month Time Period Since the Start of the Study. | 12 weeks | Participants | NUMBER | |
| SECONDARY | Proportion of Subjects With Median Serum Lactate Dehydrogenase (LDH) <1.8, >1.8 to 2.4, >2.4 to 3, and >3 Times the Upper Limit of Normal (ULN) Over the Entire Duration of the Study. | Approximately 3 years and 5 months | Participants | NUMBER | |
| SECONDARY | Proportion of Transfusion-independent Subjects at Each 3-month Time Point, With Haemoglobin (g/L) Above the Baseline Haemoglobin Value They Had at the Start of the Trial From Which They Entered CONSERVE | Baseline and every 3 months up to 39 months | Total number of subjects analyzed at each timepoint is specified. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Transfusion-independent Subjects Over the Entire Duration of the Study With Mean Haemoglobin (g/L) Above the Baseline Haemoglobin Value They Had at the Start of the Trial From Which They Entered CONSERVE | Approximately 3 years and 5 months | Total number of subjects analyzed with post-baseline values is specified. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Patients Experiencing Major Adverse Vascular Events (MAVE) Over the Entire Period of the Study. | Approximately 3 years and 5 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to First Major Adverse Vascular Event (MAVE) for Each Subject Since Joining the Study. | Approximately 3 years and 5 months | There were no Major Adverse Vascular Events (MAVEs) reported during the entire period of the study. | ||
| SECONDARY | Number of Major Adverse Vascular Events (MAVE) Over the Entire Period of the Study. | Approximately 3 years and 5 months | events | NUMBER |
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.
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GET https://conductscience.org/api/trials/v1/NCT03829449/outcomes