Other Clinical Trial - A Study to Investigate the Interaction Between

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

Acute Intermittent Porphyria (AIP) Clinical Trial

Official title:
A Drug-Drug Interaction Study to Investigate the Effect of Givosiran on the Pharmacokinetics (PK) of Midazolam, Caffeine, Losartan, Omeprazole, and Dextromethorphan in Patients With Acute Intermittent Porphyria (AIP) Who Are Asymptomatic High Excreters (ASHE)

Clinical Trial Description

n/a

Study Design

See also
	Status	Clinical Trial	Phase
	Recruiting	`NCT05502133` - Identification of Acute Intermittent Porphyria Modifying Genes
	Terminated	`NCT03547297` - INSIGHT-AHP: A Study to Characterize the Prevalence of Acute Hepatic Porphyria (AHP) in Patients With Clinical Presentation and History Consistent With AHP
	Completed	`NCT01568554` - Clinical Diagnosis of Acute Porphyria

See also

Status

Clinical Trial

Phase

Recruiting

NCT05502133 - Identification of Acute Intermittent Porphyria Modifying Genes

Terminated

NCT03547297 - INSIGHT-AHP: A Study to Characterize the Prevalence of Acute Hepatic Porphyria (AHP) in Patients With Clinical Presentation and History Consistent With AHP

Completed

NCT01568554 - Clinical Diagnosis of Acute Porphyria

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT03505853
Study type	Interventional
Source	Alnylam Pharmaceuticals
Contact
Status	Completed
Phase	Phase 1
Start date	April 26, 2018
Completion date	January 10, 2019

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms