CLINICAL TRIALS PROFILE FOR RIMANTADINE HYDROCHLORIDE

505(b)(2) Clinical Trials for Rimantadine Hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT01413490 ↗	Hepatitis C Rimantadine and Antiviral Combination Therapy	Completed	Cancer Research UK		2012-05-01	Hepatitis C virus is one of the leading causes of liver failure and liver cancer worldwide. Current treatment of hepatitis C infection is only successful in about half of those who are eligible. The current treatment aims to boost the host immune system but does not directly act on the virus. Many drugs are in various stages of development that target the virus directly - their specific mode of action is confirmed by showing the virus is forced to adapt in the presence of the drug. As with many viruses, treating with only one specific drug would quickly lead to the virus adapting and becoming resistant. We therefore need to find new combinations of directly acting drugs. Rimantadine has already been shown in the laboratory to target hepatitis C directly. We have designed this study to see if it happens in real life as well. If so, we could use rimantadine to help fight hepatitis c more effectively.
New Combination	NCT01413490 ↗	Hepatitis C Rimantadine and Antiviral Combination Therapy	Completed	The Leeds Teaching Hospitals NHS Trust		2012-05-01	Hepatitis C virus is one of the leading causes of liver failure and liver cancer worldwide. Current treatment of hepatitis C infection is only successful in about half of those who are eligible. The current treatment aims to boost the host immune system but does not directly act on the virus. Many drugs are in various stages of development that target the virus directly - their specific mode of action is confirmed by showing the virus is forced to adapt in the presence of the drug. As with many viruses, treating with only one specific drug would quickly lead to the virus adapting and becoming resistant. We therefore need to find new combinations of directly acting drugs. Rimantadine has already been shown in the laboratory to target hepatitis C directly. We have designed this study to see if it happens in real life as well. If so, we could use rimantadine to help fight hepatitis c more effectively.

All Clinical Trials for Rimantadine Hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00298233 ↗	High-Dose Versus Standard-Dose Oseltamivir to Treat Severe Influenza and Avian Influenza	Completed	University of Oxford	Phase 2	2006-02-01	Influenza, also known as the flu, is a contagious respiratory illness caused by influenza viruses. The illness can range in severity, from mild to severe to even death, and it causes an estimated 500,000 to 1,000,000 deaths worldwide each year. In the last several years, there have been increasing numbers of human cases of avian influenza, or bird flu. This trend may pose a threat of a future pandemic--worldwide outbreak of disease--with an avian influenza virus that can easily spread from person to person. Oseltamivir is an antiviral medication that is used to treat people with uncomplicated human influenza, and it may be effective in treating people with either severe human influenza or avian influenza. The purpose of this international study is to compare standard-dose oseltamivir versus high-dose oseltamivir for treating people who are hospitalized with severe human influenza or avian influenza.
NCT00298233 ↗	High-Dose Versus Standard-Dose Oseltamivir to Treat Severe Influenza and Avian Influenza	Completed	Wellcome Trust	Phase 2	2006-02-01	Influenza, also known as the flu, is a contagious respiratory illness caused by influenza viruses. The illness can range in severity, from mild to severe to even death, and it causes an estimated 500,000 to 1,000,000 deaths worldwide each year. In the last several years, there have been increasing numbers of human cases of avian influenza, or bird flu. This trend may pose a threat of a future pandemic--worldwide outbreak of disease--with an avian influenza virus that can easily spread from person to person. Oseltamivir is an antiviral medication that is used to treat people with uncomplicated human influenza, and it may be effective in treating people with either severe human influenza or avian influenza. The purpose of this international study is to compare standard-dose oseltamivir versus high-dose oseltamivir for treating people who are hospitalized with severe human influenza or avian influenza.
NCT00298233 ↗	High-Dose Versus Standard-Dose Oseltamivir to Treat Severe Influenza and Avian Influenza	Completed	World Health Organization	Phase 2	2006-02-01	Influenza, also known as the flu, is a contagious respiratory illness caused by influenza viruses. The illness can range in severity, from mild to severe to even death, and it causes an estimated 500,000 to 1,000,000 deaths worldwide each year. In the last several years, there have been increasing numbers of human cases of avian influenza, or bird flu. This trend may pose a threat of a future pandemic--worldwide outbreak of disease--with an avian influenza virus that can easily spread from person to person. Oseltamivir is an antiviral medication that is used to treat people with uncomplicated human influenza, and it may be effective in treating people with either severe human influenza or avian influenza. The purpose of this international study is to compare standard-dose oseltamivir versus high-dose oseltamivir for treating people who are hospitalized with severe human influenza or avian influenza.
NCT00298233 ↗	High-Dose Versus Standard-Dose Oseltamivir to Treat Severe Influenza and Avian Influenza	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	2006-02-01	Influenza, also known as the flu, is a contagious respiratory illness caused by influenza viruses. The illness can range in severity, from mild to severe to even death, and it causes an estimated 500,000 to 1,000,000 deaths worldwide each year. In the last several years, there have been increasing numbers of human cases of avian influenza, or bird flu. This trend may pose a threat of a future pandemic--worldwide outbreak of disease--with an avian influenza virus that can easily spread from person to person. Oseltamivir is an antiviral medication that is used to treat people with uncomplicated human influenza, and it may be effective in treating people with either severe human influenza or avian influenza. The purpose of this international study is to compare standard-dose oseltamivir versus high-dose oseltamivir for treating people who are hospitalized with severe human influenza or avian influenza.
NCT00979667 ↗	A Clinical Trial Comparing Oseltamivir With Placebo And Zanamivir With Control As First Line Treatment For Human Swine Influenza Infection	Terminated	Food and Health Bureau, Hong Kong	Phase 3	2009-10-01	To evaluate the efficacy of oseltamivir ,as compared with the placebo arm and zanamivir with its control arm with respect to symptoms duration among patients infected with influenza A (H1N1) virus.
NCT00979667 ↗	A Clinical Trial Comparing Oseltamivir With Placebo And Zanamivir With Control As First Line Treatment For Human Swine Influenza Infection	Terminated	Hospital Authority	Phase 3	2009-10-01	To evaluate the efficacy of oseltamivir ,as compared with the placebo arm and zanamivir with its control arm with respect to symptoms duration among patients infected with influenza A (H1N1) virus.

Clinical Trial Conditions for Rimantadine Hydrochloride

Condition Name

Condition Name for Rimantadine Hydrochloride
Intervention	Trials
Influenza	3
Influenza, Human	1
Severe Influenza	1
Upper Respiratory Tract Infection	1

Condition MeSH

Condition MeSH for Rimantadine Hydrochloride
Intervention	Trials
Influenza, Human	4
Respiratory Tract Infections	2
Infections	2
Infection	2

Clinical Trial Locations for Rimantadine Hydrochloride

Trials by Country

Trials by Country for Rimantadine Hydrochloride
Location	Trials
United States	21
Thailand	4
Argentina	2
Singapore	1
Hong Kong	1

Trials by US State

Trials by US State for Rimantadine Hydrochloride
Location	Trials
Georgia	1
Florida	1
Colorado	1
California	1
Arizona	1

Clinical Trial Progress for Rimantadine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Rimantadine Hydrochloride
Clinical Trial Phase	Trials
Phase 3	1
Phase 2/Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Rimantadine Hydrochloride
Clinical Trial Phase	Trials
Completed	4
Terminated	1
Withdrawn	1

Clinical Trial Sponsors for Rimantadine Hydrochloride

Sponsor Name

Sponsor Name for Rimantadine Hydrochloride
Sponsor	Trials
University of Oxford	2
National Institute of Allergy and Infectious Diseases (NIAID)	2
The Leeds Teaching Hospitals NHS Trust	1

Sponsor Type

Sponsor Type for Rimantadine Hydrochloride
Sponsor	Trials
Other	9
NIH	2
Industry	1