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Post Marketing Surveillance Study of Cuprimine

Primary Purpose

Scleroderma

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Cuprimine (penicillamine)
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Scleroderma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- None

Exclusion Criteria:

- None

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    June 14, 2011
    Last Updated
    October 21, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    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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