Post Marketing Surveillance Study of Cuprimine
Primary Purpose
Scleroderma
Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Cuprimine (penicillamine)
Sponsored by
About this trial
This is an expanded access trial for Scleroderma
Eligibility Criteria
Inclusion Criteria:
- None
Exclusion Criteria:
- None
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01374282
First Posted
June 14, 2011
Last Updated
October 21, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01374282
Brief Title
Post Marketing Surveillance Study of Cuprimine
Official Title
Post Marketing Surveillance Study of Cuprimine (MK-0172-001)
Study Type
Expanded Access
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
Cuprimine (penicillamine) was made available in the Philippines by the Sponsor under a Compassionate Special Permit issued by the Bureau of Food and Drugs. Physicians were able to request the drug for their patients from the Sponsor. A Clinical Study Report form was completed for each purchase of Cuprimine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scleroderma
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Cuprimine (penicillamine)
Intervention Description
Dosage determined by the physician based on indication for treatment
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- None
Exclusion Criteria:
- None
12. IPD Sharing Statement
Learn more about this trial
Post Marketing Surveillance Study of Cuprimine
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