Study Stopped
Subjects did not receive Hope Pharmaceuticals' Sodium Thiosulfate Injection.
Observational Follow-up to ST-001 Calciphylaxis Pain Treatment With Intravenous Sodium Thiosulfate
OF-CALISTA
1 other identifier
observational
5
1 country
3
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2017
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2017
CompletedStudy Start
First participant enrolled
October 20, 2017
CompletedFirst Posted
Study publicly available on registry
October 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 9, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 9, 2018
CompletedNovember 20, 2018
June 1, 2018
1.1 years
October 20, 2017
November 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
ST-003 Observational
Calciphylaxis patients who participated in the ST-001 CALISTA
Eligibility Criteria
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).
You may qualify if:
- 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
You may not qualify if:
- Patient did not participate in ST-001 CALISTA study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Veterans Administration Medical Center
Albany, New York, 12208, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Craig Sherman, MD
Hope Pharmaceuticals
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2017
First Posted
October 24, 2017
Study Start
October 20, 2017
Primary Completion
November 9, 2018
Study Completion
November 9, 2018
Last Updated
November 20, 2018
Record last verified: 2018-06