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GFM-Acadesine: A Phase I-II Trial of Acadesine
Plain-language guide to NCT01813838: phase 1, phase 2 non-randomized trial of AICAR, 5 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01813838
- Phase
- phase 1, phase 2
- Status
- terminated early
- Start
- 2013-06
- Completion (planned or actual)
- 2013-06
- Participants
- 5 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- SMD
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 1, phase 2 trial, researchers set out to test AICAR.
It had three arms (groups): one (experimental), one (experimental) and one (experimental).
The registry classes the interventions as drug.
More on the Plan
Phase II: To determine * response rate as defined by the 2006 modified IWG criteria * toxicity profile and safety * response duration * rate of progression to AML * overall survival.
Who Took Part
5 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: IPSS score \>1 (IPSS: Int-2 or High);. Age ≥ 18 years;. Normal liver function tests, defined by total bilirubin and transaminases less than 1.5 time the upper limit of normal;. Patient ineligible for allogeneic hematopoietic stem cell transplantation;. Written informed consent;.
The full record lists 13 inclusion and 12 exclusion criteria; among the exclusions: severe infection or any other uncontrolled severe condition; less than 30 days since prior treatment with growth factors (epo, g-csf); active cancer, or cancer during the year prior to trial entry other than basal cell carcinoma or carcinoma in situ of the cervix or breast;.
How the Study Was Run
Design: non-randomized, parallel-group and open-label.
The AICAR group and the comparison group ran side by side rather than switching.
Being open-label, the AICAR study did not mask who received what.
It started in 2013-06 with completion listed for 2013-06.
It ran at 17 sites in France (17).
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 1, phase 2, non-randomized trial of AICAR in 5 people.
Its size is small, so on its own it can only give an early look.
It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.
More context: the AICAR compound page, all human trials.
Our Notes on the Compound
AICAR: A research compound that activates AMPK, nicknamed the “exercise pill”; prohibited in sport and not approved for human use.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.