EPP Clinical Trial - Extension Study to Evaluate Safety & Tolerability of

See also
Status	Clinical Trial	Phase
Completed	`NCT04402489` - Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Erythropoietic Protoporphyria or X-Linked Protoporphyria	Phase 3
Completed	`NCT01688895` - Erythropoietic Protoporphyrias: Studies of the Natural History, Genotype-Phenotype Correlations, and Psychosocial Impact
Completed	`NCT02979249` - Oral Iron for Erythropoietic Protoporphyrias	N/A

See also

Status

Clinical Trial

Phase

Completed

NCT04402489 - Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Erythropoietic Protoporphyria or X-Linked Protoporphyria

Phase 3

Completed

NCT01688895 - Erythropoietic Protoporphyrias: Studies of the Natural History, Genotype-Phenotype Correlations, and Psychosocial Impact

Completed

NCT02979249 - Oral Iron for Erythropoietic Protoporphyrias

N/A

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	NCT05005975
Study type	Interventional
Source	Mitsubishi Tanabe Pharma America Inc.
Contact
Status	Active, not recruiting
Phase	Phase 3
Start date	August 10, 2021
Completion date	June 2025

Extension Study to Evaluate Safety and Tolerability of Oral Dersimelagon (MT-7117) in Subjects With Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms