pyridoxal phosphate has been researched along with Drug Overdose in 6 studies
Pyridoxal Phosphate: This is the active form of VITAMIN B 6 serving as a coenzyme for synthesis of amino acids, neurotransmitters (serotonin, norepinephrine), sphingolipids, aminolevulinic acid. During transamination of amino acids, pyridoxal phosphate is transiently converted into pyridoxamine phosphate (PYRIDOXAMINE).
pyridoxal 5'-phosphate : The monophosphate ester obtained by condensation of phosphoric acid with the primary hydroxy group of pyridoxal.
Drug Overdose: Accidental or deliberate use of a medication or street drug in excess of normal dosage.
Excerpt | Relevance | Reference |
---|---|---|
"Pyridoxine-dependent seizures have been recognised for 40 years, but the clinical and biochemical features are still not understood." | 8.82 | Pyridoxine-dependent seizures: a clinical and biochemical conundrum. ( Baxter, P, 2003) |
"Pyridoxine-dependent seizures have been recognised for 40 years, but the clinical and biochemical features are still not understood." | 4.82 | Pyridoxine-dependent seizures: a clinical and biochemical conundrum. ( Baxter, P, 2003) |
" This regimen was introduced in the 1970s and has remained largely unchanged even though the initial NAC infusion is frequently associated with adverse reactions, in particular nausea, vomiting, and anaphylactoid reactions." | 2.90 | Randomised open label exploratory, safety and tolerability study with calmangafodipir in patients treated with the 12-h regimen of N-acetylcysteine for paracetamol overdose-the PP100-01 for Overdose of Paracetamol (POP) trial: study protocol for a randomi ( Dear, J, 2019) |
" Primary endpoints: all participants experienced ≥1 adverse event (AE), most commonly gastrointestinal." | 2.90 | Principal results of a randomised open label exploratory, safety and tolerability study with calmangafodipir in patients treated with a 12 h regimen of N-acetylcysteine for paracetamol overdose (POP trial). ( Black, P; Dear, JW; Gallagher, B; Grahamslaw, J; Henriksen, D; Lee, RJ; Morrison, EE; O'Brien, R; Oatey, K; Oosthuyzen, W; Weir, CJ, 2019) |
"Fomepizole (4-methylpyrazole) is safe and has shown efficacy in preclinical models, human hepatocytes and in volunteers against APAP overdose." | 2.66 | Novel strategies for the treatment of acetaminophen hepatotoxicity. ( Akakpo, JY; Jaeschke, H; Ramachandran, A, 2020) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 0 (0.00) | 18.2507 |
2000's | 1 (16.67) | 29.6817 |
2010's | 3 (50.00) | 24.3611 |
2020's | 2 (33.33) | 2.80 |
Authors | Studies |
---|---|
Mullins, ME | 1 |
Yeager, LH | 1 |
Freeman, WE | 1 |
Akakpo, JY | 1 |
Ramachandran, A | 1 |
Jaeschke, H | 1 |
Dear, J | 1 |
Karlsson, JOG | 1 |
Jynge, P | 1 |
Lundström, I | 1 |
Ignarro, LJ | 1 |
Morrison, EE | 1 |
Oatey, K | 1 |
Gallagher, B | 1 |
Grahamslaw, J | 1 |
O'Brien, R | 1 |
Black, P | 1 |
Oosthuyzen, W | 1 |
Lee, RJ | 1 |
Weir, CJ | 1 |
Henriksen, D | 1 |
Dear, JW | 1 |
Baxter, P | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
A Randomised Open Label Exploratory, Safety and Tolerability Study With PP100-01 in Patients Treated With the 12-hour Regimen of N-Acetylcysteine for Paracetamol/Acetaminophen Overdose (The POP Trial)[NCT03177395] | Phase 1 | 24 participants (Actual) | Interventional | 2017-06-08 | Completed | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
The alanine aminotransferase (ALT) test is a blood test that checks for liver damage. (NCT03177395)
Timeframe: 10 hours
Intervention | U/L (Geometric Mean) |
---|---|
Acetylcysteine (N-acetylcysteine; NAC) | 41.4 |
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 22.9 |
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 25.3 |
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 15.0 |
The alanine aminotransferase (ALT) test is a blood test that checks for liver damage. (NCT03177395)
Timeframe: 20 hours
Intervention | U/L (Geometric Mean) |
---|---|
Acetylcysteine (N-acetylcysteine; NAC) | 43.3 |
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 20.4 |
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 25.4 |
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 16.4 |
The alanine aminotransferase (ALT) test is a blood test that checks for liver damage. (NCT03177395)
Timeframe: Baseline
Intervention | U/L (Geometric Mean) |
---|---|
Acetylcysteine (N-acetylcysteine; NAC) | 42.5 |
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 24.6 |
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 29.4 |
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 17.7 |
Caspace-cleaved Keratin-18 (NCT03177395)
Timeframe: Ratio - value at 20 hours divided by baseline value for each patient
Intervention | U/L (Geometric Mean) |
---|---|
Acetylcysteine (N-acetylcysteine; NAC) | 2.22 |
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 1.49 |
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 1.02 |
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 1.08 |
The shorter, Caspase cleaved form of K-18 is released following hepatocyte apoptosis (programmed cell death). (NCT03177395)
Timeframe: 10 hours
Intervention | U/L (Geometric Mean) |
---|---|
Acetylcysteine (N-acetylcysteine; NAC) | 72 |
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 53 |
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 56 |
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 78 |
The shorter, Caspase cleaved form of K-18 is released following hepatocyte apoptosis (programmed cell death). (NCT03177395)
Timeframe: 20 hours
Intervention | U/L (Geometric Mean) |
---|---|
Acetylcysteine (N-acetylcysteine; NAC) | 149 |
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 66 |
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 85 |
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 111 |
The shorter, Caspase cleaved form of K-18 is released following hepatocyte apoptosis (programmed cell death). (NCT03177395)
Timeframe: Baseline (2 hours)
Intervention | U/L (Geometric Mean) |
---|---|
Acetylcysteine (N-acetylcysteine; NAC) | 67 |
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 45 |
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 84 |
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 104 |
international normalised ratio (INR) characterise acute liver injury (ALI) and failure (ALF) (NCT03177395)
Timeframe: 10 hours
Intervention | ratio (Mean) |
---|---|
Acetylcysteine (N-acetylcysteine; NAC) | 1.30 |
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 1.17 |
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 1.20 |
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 1.22 |
international normalised ratio (INR) characterise acute liver injury (ALI) and failure (ALF) (NCT03177395)
Timeframe: 20 hours
Intervention | ratio (Mean) |
---|---|
Acetylcysteine (N-acetylcysteine; NAC) | 1.18 |
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 1.07 |
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 1.08 |
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 1.22 |
international normalised ratio (INR) characterise acute liver injury (ALI) and failure (ALF) (NCT03177395)
Timeframe: Baseline
Intervention | ratio (Mean) |
---|---|
Acetylcysteine (N-acetylcysteine; NAC) | 1.02 |
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 1.00 |
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 0.98 |
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 1.05 |
international normalised ratio (INR) characterise acute liver injury (ALI) and failure (ALF) (NCT03177395)
Timeframe: value at 20 hours divided by baseline value for each patient
Intervention | ratio (Geometric Mean) |
---|---|
Acetylcysteine (N-acetylcysteine; NAC) | 1.15 |
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 1.07 |
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 1.10 |
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 1.10 |
In paracetamol overdose, the full-length variant of Keratin-18 (K-18) is released by necrotic hepatocyte death. (NCT03177395)
Timeframe: 20 hours
Intervention | U/L (Geometric Mean) |
---|---|
Acetylcysteine (N-acetylcysteine; NAC) | 347 |
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 229 |
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 172 |
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 181 |
In paracetamol overdose, the full-length variant of Keratin-18 (K-18) is released by necrotic hepatocyte death. (NCT03177395)
Timeframe: Baseline (2 hours)
Intervention | U/L (Geometric Mean) |
---|---|
Acetylcysteine (N-acetylcysteine; NAC) | 187 |
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 177 |
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 193 |
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 128 |
In paracetamol overdose, the full-length variant of Keratin-18 (K-18) is released by necrotic hepatocyte death. (NCT03177395)
Timeframe: Ratio - value at 20 hours divided by baseline value for each patient
Intervention | U/L (Geometric Mean) |
---|---|
Acetylcysteine (N-acetylcysteine; NAC) | 1.85 |
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 1.29 |
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 0.89 |
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 1.41 |
In paracetamol overdose, the full-length variant of Keratin-18 (K-18) is released by necrotic hepatocyte death. (NCT03177395)
Timeframe: 10 hours
Intervention | U/L (Geometric Mean) |
---|---|
Acetylcysteine (N-acetylcysteine; NAC) | 182 |
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 152 |
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 170 |
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 111 |
MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose (NCT03177395)
Timeframe: 20 hours
Intervention | copies/mcL (Geometric Mean) |
---|---|
Acetylcysteine (N-acetylcysteine; NAC) | 216,256 |
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 57,664 |
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 202,271 |
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 40,745 |
MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose (NCT03177395)
Timeframe: Baseline (2 h)
Intervention | copies/mcL (Geometric Mean) |
---|---|
Acetylcysteine (N-acetylcysteine; NAC) | 146,363 |
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 116,749 |
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 194,075 |
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 36,051 |
MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose (NCT03177395)
Timeframe: Ratio - value at 20 hours divided by baseline value for each patient
Intervention | copies/mcL (Geometric Mean) |
---|---|
Acetylcysteine (N-acetylcysteine; NAC) | 1.48 |
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 0.49 |
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 1.04 |
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 1.13 |
MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose (NCT03177395)
Timeframe: 10 hours
Intervention | DCt (Mean) |
---|---|
Acetylcysteine (N-acetylcysteine; NAC) | 5.41 |
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 6.14 |
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 5.01 |
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 9.00 |
MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose (NCT03177395)
Timeframe: 20 hours
Intervention | DCt (Mean) |
---|---|
Acetylcysteine (N-acetylcysteine; NAC) | 4.85 |
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 7.12 |
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 4.49 |
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 8.44 |
MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose (NCT03177395)
Timeframe: Baseline (2 hours)
Intervention | DCt (Mean) |
---|---|
Acetylcysteine (N-acetylcysteine; NAC) | 5.58 |
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 5.85 |
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 4.43 |
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 8.73 |
MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose (NCT03177395)
Timeframe: 10 hours
Intervention | copies/mcL (Geometric Mean) |
---|---|
Acetylcysteine (N-acetylcysteine; NAC) | 206,205 |
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 109,882 |
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 196,732 |
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 37,066 |
participants required additional NAC infusions after the 12-hour NAC regimen (NCT03177395)
Timeframe: Additional NAC at 12 hour
Intervention | Participants (Count of Participants) | ||
---|---|---|---|
None | One | Two | |
Acetylcysteine (N-acetylcysteine; NAC) | 3 | 1 | 2 |
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 5 | 1 | 0 |
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 6 | 0 | 0 |
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 6 | 0 | 0 |
Adverse Events and Serious Adverse Events (NCT03177395)
Timeframe: 90 days
Intervention | participants (Number) | ||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Any Adverse event | Any serious adverse event | Adverse event after commencement of NAC treatment | Serious AE after commencement of NAC treatment | Adverse event where outcome was death | Adverse event unrelated to NAC | Adverse event possibly related to NAC | Adverse event probably related to NAC | Adverse event definitely related to NAC | Adverse event unrelated to PP100-01 | Adverse event possibly related to PP100-01 | Adverse event probably related to PP100-01 | Adverse event definitely related to PP100-01 | Any suspected unexpected serious adverse reaction | SUSAR to NAC | SUSAR to PP100-01 | SUSAR to NAC and PP100-01 | |
Acetylcysteine (N-acetylcysteine; NAC) | 6 | 2 | 6 | 1 | 0 | 3 | 2 | 3 | 2 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 6 | 4 | 5 | 1 | 0 | 5 | 2 | 2 | 3 | 6 | 4 | 0 | 0 | 0 | 0 | 0 | 0 |
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 6 | 2 | 6 | 1 | 1 | 3 | 2 | 3 | 1 | 5 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 6 | 3 | 6 | 2 | 0 | 5 | 2 | 2 | 1 | 6 | 2 | 0 | 0 | 1 | 0 | 1 | 0 |
3 reviews available for pyridoxal phosphate and Drug Overdose
Article | Year |
---|---|
Metabolic and mitochondrial treatments for severe paracetamol poisoning: a systematic review.
Topics: Acetaminophen; Acetylcysteine; Acidosis; Animals; Antidotes; Cimetidine; Drug Overdose; Edetic Acid; | 2020 |
Novel strategies for the treatment of acetaminophen hepatotoxicity.
Topics: Acetaminophen; Acetylcysteine; Animals; Antidotes; Chemical and Drug Induced Liver Injury; Drug Over | 2020 |
Pyridoxine-dependent seizures: a clinical and biochemical conundrum.
Topics: Drug Overdose; gamma-Aminobutyric Acid; Humans; Pyridoxal Phosphate; Pyridoxine; Seizures | 2003 |
2 trials available for pyridoxal phosphate and Drug Overdose
Article | Year |
---|---|
Randomised open label exploratory, safety and tolerability study with calmangafodipir in patients treated with the 12-h regimen of N-acetylcysteine for paracetamol overdose-the PP100-01 for Overdose of Paracetamol (POP) trial: study protocol for a randomi
Topics: Acetaminophen; Acetylcysteine; Chemical and Drug Induced Liver Injury; Clinical Trials Data Monitori | 2019 |
Principal results of a randomised open label exploratory, safety and tolerability study with calmangafodipir in patients treated with a 12 h regimen of N-acetylcysteine for paracetamol overdose (POP trial).
Topics: Acetaminophen; Acetylcysteine; Adult; Biomarkers; Chemical and Drug Induced Liver Injury; Drug Inter | 2019 |
1 other study available for pyridoxal phosphate and Drug Overdose
Article | Year |
---|---|
Letter in response to: "Randomised open label exploratory, safety and tolerability study with calmangafodipir in patients treated with the 12-h regimen of N acetylcysteine for paracetamol overdose-the PP100-01 for Overdose of Paracetamol (POP) trial: stud
Topics: Acetaminophen; Acetylcysteine; Drug Overdose; Edetic Acid; Humans; Pyridoxal Phosphate; Research Des | 2019 |