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Subjects did not receive Hope Pharmaceuticals' Sodium Thiosulfate Injection.
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This is an 8-week observational follow-up study of patients who participated in the ST-001 CALISTA study (A Phase 3, Intravenous Sodium Thiosulfate for Acute Calciphylaxis Treatment: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial).
This is an 8-week observational follow-up study of patients who participated in the ST-001 CALISTA study. In this ST-003 (OF-CALISTA) study, the occurrence of delayed adverse events, standard of care treatments for calciphylaxis (medications [including Sodium Thiosulfate Injection and pain medication], wound debridement, amputation, hyperbaric oxygen therapy, and surgical parathyroidectomy), and calciphylaxis-related complications (new or worsening skin lesions, ulceration, infection, sepsis and hospitalizations) will be recorded during an 8-week observation period following patient participation in the ST-001 CALISTA study (A Phase 3, Intravenous Sodium Thiosulfate for Acute Calciphylaxis Treatment: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ST-003 Observational | Calciphylaxis patients who participated in the ST-001 CALISTA |
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| Measure | Description | Time Frame |
|---|---|---|
| Observation of delayed adverse events, standard of care treatments for calciphylaxis following participation in ST-001 | Record the occurrence of delayed adverse events, standard of care treatments for calciphylaxis(medications [including Sodium Thiosulfate Injection and pain medication], wound debridement, amputation, hyperbaric oxygen therapy, and surgical parathyroidectomy), and calciphylaxis-related complications (new or worsening skin lesions, ulceration, infection, sepsis and hospitalizations) following participation in ST-001 | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
• Patient did not participate in ST-001 CALISTA study
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Those calciphylaxis patients that previously participated in the ST-001 CALISTA study (A Phase 3, Intravenous Sodium Thiosulfate for Acute Calciphylaxis Treatment: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial).
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| Name | Affiliation | Role |
|---|---|---|
| Craig Sherman, MD | Hope Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Veterans Administration Medical Center |
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| ID | Term |
|---|---|
| D002115 | Calciphylaxis |
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D002114 | Calcinosis |
| D009750 | Nutritional and Metabolic Diseases |
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| Albany |
| New York |
| 12208 |
| United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |