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A Long Term Follow-up Study of AMG0001 in Subjects With Critical Limb Ischemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02974179
Recruitment Status : Active, not recruiting
First Posted : November 28, 2016
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
AnGes USA, Inc.

Brief Summary:
Subjects from the AG-CLI-0206 phase 3 study that received AMG0001 will be eligible for the AG-CLI-0206-LTFU study

Condition or disease Intervention/treatment
Critical Limb Ischemia Biological: Subjects from Study AG-CLI-0206 who received AMG0001

Detailed Description:
The study is designed to assess the long term safety of subjects who have been treated in the phase 3 study with AMG0001. A health questionnaire will be used to collect specific information from the subject every 6 months. Only those subjects that were randomized in the AG-CLI-0206 study and who received AMG0001 are eligible to participate in this long term follow-up study. Subjects that received placebo will not be eligible for participation in this study.

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Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Long Term Follow-up Study of AMG0001 in Subjects With Critical Limb Ischemia
Actual Study Start Date : February 20, 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Group/Cohort Intervention/treatment
Subjects who received AMG0001
Subjects from Study AG-CLI-0206 who received the study product AMG0001
Biological: Subjects from Study AG-CLI-0206 who received AMG0001
Subjects from Study AG-CLI-0206 who received the study product AMG0001




Primary Outcome Measures :
  1. Assess the long term safety of subjects from the AG-CLI-0206 study who have been treated with AMG0001 [ Time Frame: 3 years from the date last subject randomized into AG-CLI-0206 study ]
    A health questionnaire will be used to collect specific information from the subject every 6 months



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with critical limb ischemia who have previously been treated with AMG0001 in the AG-CLI-0206 study.
Criteria

Inclusion Criteria:

  • Subjects who have been treated with AMG0001 in the AG-CLI-0206 study.
  • Subjects who have provided consent for this long term follow-up study either directly or through a legally authorized representative.
  • Subjects who have provided a release of information to the sponsor.

Exclusion Criteria:

  • Subjects who were not enrolled in the AGCLI-0206 study.
  • Subjects who enrolled in AG-CLI-0206 and who were not treated with AMG0001.
  • Subjects who have not provided consent to this long term follow-up study either directly or through a legally authorized representative.
  • Subjects who have not provided a release of information for the Sponsor to contact them directly via phone, email and/or mail.

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): NCT02974179


Locations
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United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
AnGes USA, Inc.
Investigators
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Principal Investigator: Richard Powell, MD Dartmouth-Hitchcock Medical Center

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Responsible Party: AnGes USA, Inc.
ClinicalTrials.gov Identifier: NCT02974179     History of Changes
Other Study ID Numbers: AG-CLI-0206-LTFU
2016-003491-41 ( EudraCT Number )
First Posted: November 28, 2016    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Additional relevant MeSH terms:
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Ischemia
Pathologic Processes