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Observational Follow-up to ST-001 Calciphylaxis Pain Treatment With Intravenous Sodium Thiosulfate (OF-CALISTA)

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ClinicalTrials.gov Identifier: NCT03319914
Recruitment Status : Terminated (Subjects did not receive Hope Pharmaceuticals' Sodium Thiosulfate Injection.)
First Posted : October 24, 2017
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease
Calciphylaxis

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).

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Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Follow-up to ST-001 Calciphylaxis Pain Treatment With Intravenous Sodium Thiosulfate
Actual Study Start Date : October 20, 2017
Actual Primary Completion Date : November 9, 2018
Actual Study Completion Date : November 9, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
ST-003 Observational
Calciphylaxis patients who participated in the ST-001 CALISTA



Primary Outcome Measures :
  1. Observation of delayed adverse events, standard of care treatments for calciphylaxis following participation in ST-001 [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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).
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03319914


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
Veterans Administration Medical Center
Albany, New York, United States, 12208
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Hope Pharmaceuticals
Investigators
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Study Director: Craig Sherman, MD Hope Pharmaceuticals

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Responsible Party: Hope Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03319914     History of Changes
Other Study ID Numbers: ST-003
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Hope Pharmaceuticals:
calciphylaxis, calcific uremic arteriolopathy,
calcium metabolism disorders
metabolic diseases
sodium thiosulfate

Additional relevant MeSH terms:
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Sodium thiosulfate
Calciphylaxis
Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases
Antidotes
Protective Agents
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Chelating Agents
Sequestering Agents