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Porphyrias clinical trials

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NCT ID: NCT03547297 Terminated - Clinical trials for Acute Hepatic Porphyria

INSIGHT-AHP: A Study to Characterize the Prevalence of Acute Hepatic Porphyria (AHP) in Patients With Clinical Presentation and History Consistent With AHP

Start date: May 29, 2018
Phase:
Study type: Observational

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 process for patients in the future.

NCT ID: NCT03505853 Completed - Clinical trials for Acute Intermittent Porphyria (AIP)

A Study to Investigate the Interaction Between Givosiran and a 5-probe Drug Cocktail in Patients With Acute Intermittent Porphyria (AIP)

Start date: April 26, 2018
Phase: Phase 1
Study type: Interventional

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 with Acute Intermittent Porphyria.

NCT ID: NCT03338816 Completed - Clinical trials for Acute Intermittent Porphyria

ENVISION: A Study to Evaluate the Efficacy and Safety of Givosiran (ALN-AS1) in Patients With Acute Hepatic Porphyrias (AHP)

Start date: November 16, 2017
Phase: Phase 3
Study type: Interventional

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).

NCT ID: NCT03118674 Completed - Hepatitis C Clinical Trials

Harvoni Treatment Porphyria Cutanea Tarda

Start date: September 6, 2017
Phase: Phase 2
Study type: Interventional

In the medical literature there case reports that Harvoni improves symptoms in patients with PCT. However, this has never been systematically tested. Therefore, the purpose of this study is to assess whether Harvoni alone is an effective therapy of active PCT in patients with Chronic Hepatitis C.

NCT ID: NCT02949830 Completed - Clinical trials for Acute Intermittent Porphyria

A Study to Evaluate Long-term Safety and Clinical Activity of Givosiran (ALN-AS1) in Patient With Acute Intermittent Porphyria (AIP)

Start date: October 2016
Phase: Phase 1/Phase 2
Study type: Interventional

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).

NCT ID: NCT02943213 Completed - Clinical trials for Acute Intermittent Porphyria

Assessment of Intra-subject Variability in the Bioavailability of Chlorpromazine Hydrochloride

Start date: November 2016
Phase: Phase 1
Study type: Interventional

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. The aim of this pilot study is to investigate intrasubject variability in the bioavailability of Chlorpromazine Hydrochloride 25 mg sugar coated tablets. Cycle aims to demonstrate that Chlorpromazine Hydrochloride has a shallow dose response curve and a wide safety margin. This will then allow for the modification of bioequivalence acceptance criteria in future pivotal studies which will reduce the number of participants required whilst still maintaining assurance of safety and efficacy. Pilot Subjects (n): 20 Periods: 2 (2xR) Dosing: Single-dose Strength: 25 mg Test Product: N/A Reference: USL PHARMA Chlorpromazine Hydrochloride Analytes (in plasma): Chlorpromazine; 7-Hydroxychlorpromazine Bioequivalence based on 90% CI (Cmax, AUC): Standard; 80.00 - 125.00%

NCT ID: NCT02935400 Active, not recruiting - Clinical trials for Acute Intermittent Porphyria

Acute Porphyria Biomarkers for Disease Activity

Start date: April 28, 2014
Phase:
Study type: Observational

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 future studies.

NCT ID: NCT02922413 Terminated - Clinical trials for Acute Intermittent Porphyria

Panhematin for Prevention of Acute Attacks of Porphyria

Start date: October 30, 2015
Phase: Phase 2
Study type: Interventional

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 porphyria. High quality studies have not been done previously for treating or preventing acute attacks with hemin. The lack of strong evidence for efficacy of hemin for treatment and prevention of attacks limits its availability for patients with acute porphyrias. Funding source: FDA Office of Orphan Product Development (FDA OOPD) FD-R-03720

NCT ID: NCT02452372 Completed - Clinical trials for Acute Intermittent Porphyria

A Phase 1 Study of Givosiran (ALN-AS1) in Patients With Acute Intermittent Porphyria (AIP)

Start date: May 6, 2015
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT02240784 Completed - Clinical trials for Acute Hepatic Porphyria

EXPLORE: A Natural History Study of Acute Hepatic Porphyria (AHP)

Start date: August 2014
Phase:
Study type: Observational

The purpose of this study is to characterize the natural history and clinical management of Acute Hepatic Porphyria (AHP) patients with recurring attacks.