Clinical trials: Acute Intermittent Porphyria (AIP)
Anti-Psychotic, Management of Manifestations of Psychotic Disorders
Assessment of Intra-subject Variability in the Bioavailability of Chlorpromazine Hydrochloride
Cycle Pharmaceuticals Ltd. (Cycle) is developing an oral tablet formulation of Chlorpromazine Hydrochloride and intends to conduct bioequivalence trials to demonstrate its similarity to the RLD.
- Conditions
- Anti-Psychotic, Management of Manifestations of Psychotic Disorders, Treatment of Schizophrenia, Control Nausea and Vomiting
- Trial name
- NCT02943213
- Testing
- Chlorpromazine Hydrochloride
- Where
- South Africa
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Cycle Pharmaceuticals Ltd.
Acute Porphyrias, Cutaneous Porphyrias
Longitudinal Study of the Porphyrias
The objective of this protocol is to conduct a longitudinal multidisciplinary investigation of the human porphyrias including the natural history, morbidity, pregnancy outcomes, and mortality in people with these disorders.
- Trial name
- NCT01561157
- Where
- 16 sites in United States
- Volunteers
- 1,500 people
- Sponsor
- The American Porphyrias Expert Collaborative
Hereditary Coproporphyria (HCP), Acute Intermittent Porphyria (AIP)
Clinical Diagnosis of Acute Porphyria
The purpose of this study is to test whether a focused questionnaire and laboratory tests can better define risk factors associated with possible genetic porphyria.
- Conditions
- Hereditary Coproporphyria (HCP), Acute Intermittent Porphyria (AIP), Variegate Porphyria (VP)
- Trial name
- NCT01568554
- Where
- 6 sites in United States
- Volunteers
- 148 people
- Sponsor
- University of California, San Francisco
Acute Intermittent Porphyria
A Study to Evaluate Long-term Safety and Clinical Activity of Givosiran (ALN-AS1) in Patient With Acute Intermittent Porphyria (AIP)
The purpose of this study is to determine the long-term safety, tolerability and pharmacokinetics of givosiran (ALN-AS1) in AIP patients who completed study ALN-AS1-001 (NCT02452372).
- Trial name
- NCT02949830
- Testing
- Givosiran
- Where
- 5 sites in United States, Sweden and 1 more
- Volunteers
- 16 people
- Sponsor
- Alnylam Pharmaceuticals
Acute Intermittent Porphyria, Hereditary Coproporphyria
Panhematin for Prevention of Acute Attacks of Porphyria
The purpose of this study is to determine if Panhematin is safe and effective for prevention of acute attacks of porphyria. The study aims to provide high quality evidence for the use on hemin for prevention of acute attacks of…
- Conditions
- Acute Intermittent Porphyria, Hereditary Coproporphyria, Variegate Porphyria
- Trial name
- NCT02922413
- Testing
- Hemin for injection
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- The University of Texas Medical Branch, Galveston
Acute Intermittent Porphyria (AIP), Acute Hepatic Porphyria (AHP)
A Study to Investigate the Interaction Between Givosiran and a 5-probe Drug Cocktail in Patients With Acute Intermittent Porphyria (AIP)
The purpose of this study is to evaluate the effect of givosiran on the pharmacokinetics of the 5-probe cocktail of midazolam, caffeine, losartan, omeprazole, and dextromethorphan, and their metabolites, in asymptomatic patients…
- Conditions
- Acute Intermittent Porphyria (AIP), Acute Hepatic Porphyria (AHP), Porphyria, Acute Intermittent, Acute Porphyria
- Trial name
- NCT03505853
- Testing
- Givosiran, 5-probe cocktail
- Where
- Sweden
- Volunteers
- 10 people
- Sponsor
- Alnylam Pharmaceuticals
Acute Porphyrias
Controlled Trial of Panhematin in Treatment of Acute Attacks of Porphyria
This study aims to provide high quality evidence for the effectiveness and safety of hemin (PanhematinTM , Recordati) for treatment of acute attacks of porphyria.
- Trial name
- NCT02180412
- Testing
- Panhematin, Glucose
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- The University of Texas Medical Branch, Galveston
Acute Intermittent Porphyria
Porphozym in the Treatment of Acute Attacks in AIP
A multi-centre, double-blind, randomized, placebo controlled, parallel group trial, investigating the efficacy and safety of Porphozym (recombinant human porphobilinogen deaminase)in the treatment of acute attacks in AIP.
- Trial name
- NCT00418795
- Testing
- recombinant human porphobilinogen deaminase (Porphozym)
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Zymenex A/S
Acute Hepatic Porphyria, Hepatic Porphyrias
INSIGHT-AHP: A Study to Characterize the Prevalence of Acute Hepatic Porphyria (AHP) in Patients With Clinical Presentation and History Consistent With AHP
This study will use specific diagnostic tests on a group of patients who are experiencing symptoms typical of acute hepatic porphyria (AHP) to determine how many have the condition, and to potentially help improve the diagnostic…
- Conditions
- Acute Hepatic Porphyria, Hepatic Porphyrias, Acute Intermittent Porphyria (AIP), Hereditary Coproporphyria (HCP)
- Trial name
- NCT03547297
- Where
- 12 sites in United States
- Volunteers
- 212 people
- Sponsor
- Alnylam Pharmaceuticals
Acute Intermittent Porphyria
Dental Health, Diet, Inflammation and Biomarkers in Patients With Acute Intermittent Porphyria(AIP)
Acute intermittent porphyria (AIP) is an autosomal dominant inherited disease, which is relatively prevalent in northern Norway with a total of around 90 patients. This provides us with a special opportunity to study AIP.
- Trial name
- NCT01617642
- Where
- Norway
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Nordlandssykehuset HF
Porphyria, Acute Intermittent
Clinical Research on Acute Intermittent Porphyria and the Use of Carbohydrate-Rich Diet as a Treatment
The main aim of this clinical trial is to learn about the effect of carbohydrate-rich diet as a treatment for AIP (acute intermittent porphyria).
- Trial name
- NCT06273644
- Testing
- Carbohydrates
- Where
- 3 sites in Norway, Sweden
- Volunteers
- 50 people
- Sponsor
- Nordlandssykehuset HF
Acute Intermittent Porphyria
A Phase 1 Study of Givosiran (ALN-AS1) in Patients With Acute Intermittent Porphyria (AIP)
The purpose of this study is to evaluate the safety and tolerability of givosiran (ALN-AS1) in AIP patients as well as to characterize pharmacokinetics (PK) and pharmacodynamics (PD) of ALN-AS1 in AIP patients.
- Trial name
- NCT02452372
- Testing
- givosiran (ALN-AS1), Sterile Normal Saline (0.9% NaCl)
- Where
- 6 sites in United States, Sweden and 1 more
- Volunteers
- 40 people
- Sponsor
- Alnylam Pharmaceuticals
Acute Hepatic Porphyria
Expanded Access Protocol of Givosiran for Patients With Acute Hepatic Porphyria
The purpose of this study is to provide expanded access of givosiran to patients with Acute Hepatic Porphyria (AHP).
- Trial name
- NCT04056481
- Testing
- Givosiran
- Sponsor
- Alnylam Pharmaceuticals
Acute Hepatic Porphyria, Acute Intermittent Porphyria
ENVISION: A Study to Evaluate the Efficacy and Safety of Givosiran (ALN-AS1) in Patients With Acute Hepatic Porphyrias (AHP)
The purpose of this study is to evaluate the effect of subcutaneous givosiran (ALN-AS1), compared to placebo, on the rate of porphyria attacks in patients with Acute Hepatic Porphyrias (AHP).
- Conditions
- Acute Hepatic Porphyria, Acute Intermittent Porphyria, Porphyria, Acute Intermittent, Acute Porphyria
- Trial name
- NCT03338816
- Testing
- Givosiran
- Where
- 36 sites in United States, Australia and 16 more
- Volunteers
- 94 people
- Sponsor
- Alnylam Pharmaceuticals
Acute Intermittent Porphyria, Hereditary Coproporphyria
Acute Porphyria Biomarkers for Disease Activity
The long term objective of the research is to identify new biomarkers of disease activity in the human acute porphyrias. This pilot study is intended to provide pilot and feasibility data needed to plan larger and more definitive…
- Conditions
- Acute Intermittent Porphyria, Hereditary Coproporphyria, Variegate Porphyria
- Trial name
- NCT02935400
- Testing
- Hemin
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- The University of Texas Medical Branch, Galveston
Porphyria
Studies in Porphyria III: Heme and Tin Mesoporphyrin in Acute Porphyrias
OBJECTIVES: I. Compare the efficacy of heme arginate, singly or in combination with tin mesoporphyrin, in lowering porphyrin precursors in patients with asymptomatic acute intermittent porphyria. II.
- Trial name
- NCT00004396
- Testing
- heme arginate, tin mesoporphyrin
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- National Center for Research Resources (NCRR)
Acute Intermittent Porphyria (AIP)
Identification of Acute Intermittent Porphyria Modifying Genes
This study proposes to identify the predisposing/protective modifying genes that underlie the acute attacks in symptomatic patients with Acute Intermittent Porphyria (AIP), an autosomal dominant inborn error of heme biosynthesis.
- Trial name
- NCT05502133
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Porphyrias, Hepatic
Acute Intermittent Porphyria Related Abnormalities in Cardiovascular System
This study aims to assess the changes in the cardiovascular system in patients with acute intermittent porphyria (AIP).
- Trial name
- AIPRACUS (NCT05882136)
- Where
- 2 sites in Poland
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- National Institute of Cardiology, Warsaw, Poland
Acute Intermittent Porphyria
Observational Study of Acute Intermittent Porphyria Patients
This is an observational prospective study that will allow evaluating the clinical and laboratory parameters evolution of at least eight patients with AIP.
- Trial name
- NCT02076763
- Where
- 2 sites in Spain
- Volunteers
- 9 people
- Sponsor
- Digna Biotech S.L.
Porphyria
Phase I/II Study of Heme Arginate and Tin Mesoporphyrin for Acute Porphyria
OBJECTIVES: I. Evaluate the efficacy and safety of heme arginate in the treatment of 20 patients with acute attacks of porphyria. II.
- Trial name
- NCT00004789
- Testing
- heme arginate, tin mesoporphyrin
- Volunteers
- 59 people
- Sponsor
- National Center for Research Resources (NCRR)