Observational Follow-up to ST-001 Calciphylaxis Pain Treatment With Intravenous Sodium Thiosulfate

Terminated

• Conditions: Calciphylaxis

• Registration Number: NCT03319914
• Lead Sponsor: Hope Pharmaceuticals

Brief Summary

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).

Detailed Description

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).

Study Timeline

• Study Start: 2017-10-20
• Study First Submitted: 2017-10-20
• Study First Submitted QC: 2017-10-20
• Study First Posted: 2017-10-24
• Status Verified: 2018-06
• Primary Completion: 2018-11-09
• Study Completion: 2018-11-09
• Last Update Submitted: 2018-11-18
• Last Update Posted: 2018-11-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Previously enrolled as a patient in ST-001 CALISTA study
• Willing to provide written informed consent
• Willing and able to adhere to all study-related procedures
• Willing to authorize release of medical records
• Willing to authorize collection of medical data from health care providers
• Provide email, home address and phone number where he/she can be reached

Exclusion Criteria

• Patient did not participate in ST-001 CALISTA study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Observation of delayed adverse events, standard of care treatments for calciphylaxis following participation in ST-001	8 weeks	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

Trial Locations

Locations (3)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Veterans Administration Medical Center; 🇺🇸 Albany, New York, United States