Other Clinical Trial - Randomized Global Phase 3 Study to Evaluate

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04880187` - Safety, Tolerability, and Efficacy of AXA1125 in NASH With Fibrosis	Phase 2
Completed	`NCT04052516` - A Phase 2b Study of Icosabutate in Fatty Liver Disease	Phase 2
Completed	`NCT02098317` - DHA and Vitamin D in Children With Biopsy-proven NAFLD	Phase 3
Terminated	`NCT04065841` - Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis.	Phase 2

See also

Status

Clinical Trial

Phase

Recruiting

NCT04880187 - Safety, Tolerability, and Efficacy of AXA1125 in NASH With Fibrosis

Phase 2

Completed

NCT04052516 - A Phase 2b Study of Icosabutate in Fatty Liver Disease

Phase 2

Completed

NCT02098317 - DHA and Vitamin D in Children With Biopsy-proven NAFLD

Phase 3

Terminated

NCT04065841 - Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis.

Phase 2

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	NCT02548351
Study type	Interventional
Source	Intercept Pharmaceuticals
Contact
Status	Terminated
Phase	Phase 3
Start date	September 22, 2015
Completion date	September 15, 2023

Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment — REGENERATE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms