Trial · NCT03922308
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 32
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | ADAMTS-13 Activity Levels | Up to Days 11 or 12 | ADAMTS-13 Activity Levels was assessed by fluorescence resonance energy transfer (FRETS) ADAMTS13 activity, with or without SHP655 Supplementation. Schedule A (Days 1, 2, 3, 4, 6, 8, 11, and every 3 days thereafter) or Schedule B (Days 1, 2, 3, 5, 7, 9, 12, and every 3 days thereafter). Data is reported for multiple timepoints as Within 15 minutes pre-PEX and post-PEX; Within 15 minutes, 0.5-3 hours, 4-6 hours post end of investigational product (IP) infusion 1; Within 15 minutes, 0.5-3 hours post end IP infusion 2; 30 minutes pre-IP infusion 2 of Schedule A and Schedule B (up to Day 11 or 12). |
| Primary | Platelet Count | Baseline and end of study (EOS) (up to approximately 15 months) | The platelet counts are reported in units of 10\^9 per liter blood. |
| Primary | Lactate Dehydrogenase (LDH) Levels | Baseline and EOS (up to approximately 15 months) | The lactate dehydrogenase levels are reported. |
| Secondary | Dose(s) of SHP655 Needed to Achieve and Maintain Adequate Plasma Levels of rADAMTS-13 | From start of study drug administration up to 13 weeks (following remission up to 6 months) | Dose(s) of SHP655 needed to achieve and maintain adequate plasma levels of rADAMTS-13 in order to support induction of remission and to reduce the number of PEX procedures needed for the treatment of acute aTTP episodes was assessed. |
| Secondary | PK/PD Temporal Relationship of Safety and Efficacy Parameter as a Function of ADAMTS-13 Activity | Up to 6 months | Parameters included platelet and LDH counts. |
| Secondary | Number of Participants With ADAMTS-13 Binding Antibodies Per Titer | Baseline and EOS (up to approximately 15 months) | Antibody titer indicates the level of the antibodies in a blood sample, defined as the greatest dilution (or lowest concentration) of the blood sample at which an antibody assay (such as ELISA for e.g.), still produces a detectable positive result. Data is presented per titer for ADA positive participants only. |
| Secondary | Inhibitory Autoantibodies (Nab) Titer Levels | Baseline and EOS (up to approximately 15 months) | NAb titers were summarized (median, minimum and maximum) at baseline and EOS per treatment arms, in those subjects with NAb positive results (NAb positive is defined as titer value \>=0.6 BU/mL). |
| Secondary | ADAMTS-13 Activity Levels in Participants Receiving Additional SHP655 for up to 30 Days After Resolution by Using FRETS | At Days 3, 7, 10, 21, 28, 42, 56 and 84 | ADAMTS-13 activity levels in participants receiving additional SHP655 for up to 30 days after the resolution of the thrombotic thrombocytopenic purpura (TTP) episode were assessed. Resolution was defined as a normal platelet count and LDH \<2 ULN for at least 48 hours following initial normalization of platelet count (acute episode period). |
| Secondary | Relationship Between ADAMTS-13 Activity and End-organ Disease Status | Up to 6 months | End-organ disease status were evaluated for renal, cardiac and neurological diseases. |
| Secondary | Predose Concentration (Cpre) to Maximum Plasma Concentration (Cmax) Ratio | Pre-PEX and post-PEX at multiple timepoints at Days 1, 2, 3, 4 or 5, 6 or 7, 8 or 9, and 11 or 12 | |
| Secondary | AUC Overall: Area Under the Plasma Concentration Time Curve ADAMTS13 Activity by Using FRETS | Within 15 min pre-PEX and at multiple timepoints Post PEX at Days 1, 2, 3, 4 or 5 and 6 or 7 | |
| Secondary | Systemic and Antibody Induced Clearance | 15 minutes pre-PEX,15 minutes post-PEX,15 minutes, 0.5-3 hours, 4-6 hours post end of IP infusion 1,30 minutes pre-IP infusion 2,15 minutes, 0.5-3 hours post-IP infusion 2 of Schedule A or Schedule B (up to 6 months) | |
| Secondary | Cmax: Maximum ADAMTS-13 Activity Between PEX or SHP655 Infusions by Using FRETS | Pre-PEX and post-PEX at multiple timepoints at Days 1, 2, 3, 4 or 5, 6 or 7, 8 or 9, and 11 or 12 | |
| Secondary | Trough Levels of ADAMTS-13 Prior PEX ADAMTS13 Activity by Using FRETS | Within 15 min pre-PEX and at multiple timepoints Post PEX at Days 2, 3, 4 or 5 and 6 or 7 | |
| Secondary | Percentage of Participants With ADAMTS-13 Activity Trough Levels >10% | Pre-dose at Days 2, 3 4 or 5, 6 or 7, 8 or 9, and 11 or 12 | |
| Secondary | Number of Participants Who Achieved Remission Following Normalization of Platelet Count | From the start of study drug administration up to 6 months post remission | Remission was defined as the time taken to achieve platelet count ≥150,000/μL, which was confirmed by a second normal platelet count ≥150,000/μL and LDH \<2 ULN 48 hours following initial normalization. |
| Secondary | Percentage of Participants Achieving Remission | From the start of study drug administration up to 6 months post remission | Remission was defined as a normal platelet count and LDH \<2 upper limit of normal (ULN) for at least 48 hours following initial normalization of platelet count (acute episode period). Normalization of platelet count was defined ≥150,000/μL, which was confirmed by a second normal platelet count ≥150,000/μL and LDH \<2 ULN. |
| Secondary | Time to First Exacerbation | From start of study drug administration up to EOS (up to approximately 15 months) | Exacerbation was defined as recurrent thrombocytopenia following a response and requiring a reinitiation of daily plasma exchange treatment after ≥1 day but ≤30 days of no plasma exchange treatment. Data is reported based on Kaplan-Meier estimates. Data was reported for time to first exacerbation in categories for participants enrolled before protocol amendment 4 (from study start up to 11 months) and after protocol amendment 4 (from 11 months up to the EOS). |
| Secondary | Time to Relapse | From start of study drug administration up to EOS (up to approximately 15 months) | Relapse was determined by platelet count or the occurrence after remission of a major clinical event (e.g., Myocardial Infraction (MI), stroke, death) deemed by the investigator to be related to aTTP. Data was reported for time to relapse in categories for participants enrolled before protocol amendment 4 (from study start up to 11 months) and after protocol amendment 4 (from 11 months up to the EOS). |
| Secondary | Percentage of Participants With Exacerbation | From start of study drug administration up to EOS (up to approximately 15 months) | Exacerbation was determined by platelet count or the occurrence after remission of a major clinical event (e.g., myocardial infarction (MI), stroke, death) deemed by the investigator to be related to aTTP. Data was reported for percentage of participants with exacerbation in categories for participants enrolled before protocol amendment 4 (from study start up to 11 months) and after protocol amendment 4 (from 11 months up to the EOS). |
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.
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