Critical Limb IschemiaNCT02974179
A Long Term Follow-up Study of AMG0001 in Subjects With Critical Limb Ischemia
An observational study of Critical Limb Ischemia, run by AnGes USA, Inc. at 1 site in United States.
Trial summary
Subjects from the AG-CLI-0206 phase 3 study that received AMG0001 will be eligible for the AG-CLI-0206-LTFU study Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Critical Limb Ischemia
- What is being tested?
- Subjects from Study AG-CLI-0206 who received AMG0001
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2017to 10 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with critical limb ischemia who have previously been treated with AMG0001 in the AG-CLI-0206 study.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Subjects from the AG-CLI-0206 phase 3 study that received AMG0001 will be eligible for the AG-CLI-0206-LTFU study
Read the 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.
- Conditions
- Critical Limb Ischemia
- Being tested
- Subjects from Study AG-CLI-0206 who received AMG0001
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subjects from Study AG-CLI-0206 who received AMG0001Biological
Subjects from Study AG-CLI-0206 who received the study product AMG0001
| Study group | Role | What they receive |
|---|---|---|
| Subjects who received AMG0001 | Subjects from Study AG-CLI-0206 who received the study product AMG0001 Receives: Biological: Subjects from Study AG-CLI-0206 who received AMG0001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the long term safety of subjects from the AG-CLI-0206 study who have been treated with AMG0001
A health questionnaire will be used to collect specific information from the subject every 6 months
Measured: 3 years from the date last subject randomized into AG-CLI-0206 study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2016 (estimated)
- Study start20 Feb 2017
- Primary completion10 Jan 2020
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- AnGes USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Powell, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974179
- Sponsor's protocol ID
- AG-CLI-0206-LTFU
- Other IDs
- 2016-003491-41, 2016
- Status last verified
- Mar 2020
- First submitted
- 23 Nov 2016
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long Term Follow-up Study of AMG0001 in Subjects With Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT02974179
- Acronym / sponsor ID
- AG-CLI-0206-LTFU
- Conditions
- Critical Limb Ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- AnGes USA, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 28 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subjects from the AG-CLI-0206 phase 3 study that received AMG0001 will be eligible for the AG-CLI-0206-LTFU study
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects who received AMG0001 | – | Biological: Subjects from Study AG-CLI-0206 who received AMG0001Subjects from Study AG-CLI-0206 who received the study product AMG0001 |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with critical limb ischemia who have previously been treated with AMG0001 in the AG-CLI-0206 study.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subjects from Study AG-CLI-0206 who received AMG0001Subjects from Study AG-CLI-0206 who received the study product AMG0001 | Biological | Subjects who received AMG0001 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Powell, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Limb Ischemia, run by AnGes USA, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2020.