13 completed, 3 recruiting, 2 terminated, 1 active not recruiting. 6 Phase 1, 5 Phase 2, 2 Phase 3, 1 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 6 | Completed 6 |
| Phase 2 | 5 | Completed 4, Terminated 1 |
| Phase 3 | 2 | Completed 2 |
| Not applicable | 1 | Recruiting 1 |
Follow Porphyria, Acute Intermittent: new trials by email Literature Review of Porphyria, Acute Intermittent trials Research Report on Porphyria, Acute Intermittent
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Clinical Research on Acute Intermittent Porphyria and the Use of Carbohydrate-Rich Diet as a Treatment Carbohydrates - Porphyria, Acute Intermittent | Not applicable | Recruiting | Nordlandssykehuset HF | 50 | 2024-01-27 | 2026-03-27 |
| Identification of Acute Intermittent Porphyria Modifying Genes Acute Intermittent Porphyria (AIP) | Recruiting | Icahn School of Medicine at Mount Sinai | 150 | 2022-09-23 | 2026-09-10 | |
| Acute Intermittent Porphyria Related Abnormalities in Cardiovascular System Porphyrias, Hepatic | Completed | National Institute of Cardiology, Warsaw, Poland | 180 | 2019-04-05 | 2024-04-02 | |
| Evidence-based Assessment of Medication Sensitivity in Acute Hepatic Porphyria Web-based Survey - Porphyrias | Completed | University of South Florida | 60 | 2019-04-03 | 2019-10-16 | |
| INSIGHT-AHP: A Study to Characterize the Prevalence of Acute Hepatic Porphyria (AHP) in Patients With Clinical Presentation and History Consistent With AHP Acute Hepatic Porphyria, Hepatic Porphyrias | Terminated | Alnylam Pharmaceuticals | 212 | 2018-05-29 | 2019-01-25 | |
| A Study to Investigate the Interaction Between Givosiran and a 5-probe Drug Cocktail in Patients With Acute Intermittent Porphyria (AIP) Givosiran, 5-probe cocktail - Acute Intermittent Porphyria (AIP), Acute Hepatic Porphyria (AHP) | Phase 1 | Completed | Alnylam Pharmaceuticals | 10 | 2018-04-26 | 2019-03-12 |
| ENVISION: A Study to Evaluate the Efficacy and Safety of Givosiran (ALN-AS1) in Patients With Acute Hepatic Porphyrias (AHP) Givosiran, Placebo - Acute Hepatic Porphyria, Acute Intermittent Porphyria | Phase 3 | Completed | Alnylam Pharmaceuticals | 94 | 2017-11-16 | 2024-04-22 |
| Assessment of Intra-subject Variability in the Bioavailability of Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride - Anti-Psychotic, Management of Manifestations of Psychotic Disorders | Phase 1 | Completed | Cycle Pharmaceuticals Ltd. | 20 | 2016-11-01 | 2017-11-14 |
| A Study to Evaluate Long-term Safety and Clinical Activity of Givosiran (ALN-AS1) in Patient With Acute Intermittent Porphyria (AIP) Givosiran - Acute Intermittent Porphyria | Phase 1 / Phase 2 | Completed | Alnylam Pharmaceuticals | 16 | 2016-10-01 | 2024-03-12 |
| Panhematin for Prevention of Acute Attacks of Porphyria Hemin for injection, Placebo - Acute Intermittent Porphyria, Hereditary Coproporphyria | Phase 2 | Terminated | The University of Texas Medical Branch, Galveston | 13 | 2015-10-30 | 2026-01-30 |
| A Phase 1 Study of Givosiran (ALN-AS1) in Patients With Acute Intermittent Porphyria (AIP) givosiran (ALN-AS1), Sterile Normal Saline (0.9% NaCl) - Acute Intermittent Porphyria | Phase 1 | Completed | Alnylam Pharmaceuticals | 40 | 2015-05-06 | 2018-06-14 |
| Controlled Trial of Panhematin in Treatment of Acute Attacks of Porphyria Panhematin, Glucose - Acute Porphyrias | Phase 2 | Completed | The University of Texas Medical Branch, Galveston | 20 | 2014-04-28 | 2025-04-11 |
| Acute Porphyria Biomarkers for Disease Activity Hemin - Acute Intermittent Porphyria, Hereditary Coproporphyria | Active not recruiting | The University of Texas Medical Branch, Galveston | 50 | 2014-04-28 | 2026-05-12 | |
| Phase I Gene Therapy Clinical Trial Using the Vector rAAV2/5-PBGD for the Treatment of Acute Intermittent Porphyria rAAV2/5-PBGD vector dosage 1, rAAV2/5-PBGD vector dosage 2, rAAV2/5-PBGD vector dosage 3 - Acute Intermittent Porphyria | Phase 1 | Completed | Digna Biotech S.L. | 8 | 2012-11-01 | 2014-12-18 |
| Dental Health, Diet, Inflammation and Biomarkers in Patients With Acute Intermittent Porphyria(AIP) Acute Intermittent Porphyria | Unknown | Nordlandssykehuset HF | 100 | 2012-07-01 | 2024-05-09 | |
| Clinical Diagnosis of Acute Porphyria Hereditary Coproporphyria (HCP), Acute Intermittent Porphyria (AIP) | Completed | University of California, San Francisco | 148 | 2011-12-01 | 2021-09-28 | |
| Observational Study of Acute Intermittent Porphyria Patients Acute Intermittent Porphyria | Completed | Digna Biotech S.L. | 9 | 2011-08-01 | 2014-03-12 | |
| Longitudinal Study of the Porphyrias Acute Porphyrias, Cutaneous Porphyrias | Recruiting | The American Porphyrias Expert Collaborative | 1500 | 2010-11-01 | 2026-05-15 | |
| Porphozym in the Treatment of Acute Attacks in AIP recombinant human porphobilinogen deaminase (Porphozym) - Acute Intermittent Porphyria | Phase 2 / Phase 3 | Completed | Zymenex A/S | 36 | 2003-06-11 | 2018-03-09 |
| Phase I/II Study of Heme Arginate and Tin Mesoporphyrin for Acute Porphyria heme arginate, tin mesoporphyrin - Porphyria | Phase 1 / Phase 2 | Completed | National Center for Research Resources (NCRR) | 59 | 1993-07-01 | 2005-06-24 |
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Porphyrias (13) · Coproporphyria, Hereditary (8) · Porphyria, Variegate (7) · Porphyrias, Hepatic (2) · Arrhythmias, Cardiac (1) · Coproporphyria (1) · Heart Failure (1) · Hypertension (1) · Inflammation (1) · Metabolism, Inborn Errors (1) · Protoporphyria, Erythropoietic (1) · Rare Diseases (1) · Vomiting (1)
Congenital, Hereditary, and Neonatal Diseases and Abnormalities (21) · Digestive System Diseases (21) · Genetic Diseases, Inborn (21) · Liver Diseases (21) · Metabolic Diseases (21) · Nutritional and Metabolic Diseases (21) · Skin Diseases (21) · Skin Diseases, Genetic (21) · Skin and Connective Tissue Diseases (21) · Porphyrias, Hepatic (19) · Porphyrias (8) · Pathological Conditions, Signs and Symptoms (4) · Pathologic Processes (3) · Cardiovascular Diseases (1) · Disease Attributes (1)
givosiran (5) · Hemin (3) · Carbohydrates (1) · Chlorpromazine (1) · Glucose (1) · Injections (1) · Tablets (1) · heme arginate (1) · tin mesoporphyrin (1)
Alnylam Pharmaceuticals (6) · The University of Texas Medical Branch, Galveston (3) · Digna Biotech S.L. (2) · Nordlandssykehuset HF (2) · Cycle Pharmaceuticals Ltd. (1) · Icahn School of Medicine at Mount Sinai (1) · National Center for Research Resources (NCRR) (1) · National Institute of Cardiology, Warsaw, Poland (1) · The American Porphyrias Expert Collaborative (1) · University of California, San Francisco (1) · University of South Florida (1) · Zymenex A/S (1)
United States (12) · Sweden (5) · Spain (3) · United Kingdom (3) · Norway (2) · Poland (2) · Australia (1) · Bulgaria (1) · Canada (1) · Denmark (1) · Finland (1) · France (1) · Germany (1) · Italy (1) · Japan (1)
Jesus Prieto, MD (2) · Juan Ruiz, MD (2) · Karl E Anderson, MD (2) · Rafael Enriquez de Salamanca, MD (2) · Amy Simon, MD (1) · Bruce Wang, M.D. (1) · Bruce Wang, MD (1) · Christer Andersson, MD (1) · D. Montgomery Bissell, MD (1) · Dr. Yolandi Swart, FCPHM(SA) (1) · Eliane Sardh, MD PhD (1) · Elin Storjord, MD PhD (1) · Herbert L. Bonkovsky, M.D. (1) · Hetanshi Naik, PhD (1)
PMID 42833135, PMID 27212246, PMID 39363243, PMID 25016127, PMID 28614581, PMID 30726693, PMID 32521132, PMID 32681675, PMID 32916704, PMID 36028858, PMID 37479139, PMID 38044204, PMID 39115302, PMID 39969427, PMID 41388232, PMID 42106273
U54DK083909 (2), 2016 (1)