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Use Of F-652 In Patients With Alcoholic Hepatitis

Scottsdale/Phoenix, AZ, Jacksonville, FL, Mankato, MN, Rochester, MN

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Use Of F-652 In Patients With Alcoholic Hepatitis

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
1/2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

Alcoholic hepatitis is a syndrome of progressive inflammatory liver injury associated with long-term heavy intake of ethanol. The pathogenesis is not completely understood. Patients who are severely affected present with subacute onset of fever, hepatomegaly, leukocytosis, marked impairment of liver function (e.g., jaundice, coagulopathy), and manifestations of portal hypertension (e.g., ascites, hepatic encephalopathy, variceal hemorrhage). However, milder forms of alcoholic hepatitis often do not cause any symptoms. Alcoholic hepatitis usually persists and progresses to cirrhosis if heavy alcohol use continues. If alcohol use ceases, alcoholic hepatitis resolves slowly over weeks to months, sometimes without permanent sequelae but often with residual cirrhosis. F-652 is a recombinant fusion protein containing human interleukin 22 (IL-22) and human Immunoglobulin G2 (IgG2)-Fc produced in CHO cells in serum-free culture. F-652 under development is intended to treat patients with graft vs host disease (GvHD) after bone marrow transplantation, and acute alcoholic hepatitis (AAH), a severe form of alcoholic liver disease (ALD). Both GvHD and AAH are diseases with unmet medical need. The current investigational new drug (IND) application is to conduct a phase Ia clinical study in GvHD patients to evaluate the safety and pharmacokinetic profile, and biomarkers of F-652 treatment by intravenous infusion (IV). IL-22 is a member of the IL-10 family of cytokines which control bacterial infection, homeostasis, and tissue repair. IL-22 may be used to treat patients with ALD because of its antioxidant, anti-apoptotic, anti-steatotic, anti-microbial, and proliferative effect that have been demonstrated in various experimental systems.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, AZ	Closed for enrollment	View complete study & contact information
Jacksonville, FL	Closed for enrollment
Mankato, MN	Closed for enrollment
Rochester, MN	Closed for enrollment

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Site IRB:
15-003249
NCT ID:
NCT02655510
Sponsor Protocol Number:
15-003249

A Study To Determine The Effects Of A Mechanical Device To Treat Swelling Of The Face And Neck Following Treatment For Cancer.

Scottsdale/Phoenix, AZ
- See Details
A Study To Determine The Effects Of A Mechanical Device To Treat Swelling Of The Face And Neck Following Treatment For Cancer.
- Study type:
  Interventional
  Describes the nature of a clinical study. Types include:
  
  Observational study — observes people and measures outcomes without affecting results.
  
  Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
  
  Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Study phase:
  1
  During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
About this study

This study aims to assess the utility of pharyngeal manometry measures as a novel approach in quantifying internal lymphedema and compare success rates in reducing internal lymphedema using manual lymphatic drainage (MLD) versus use of a pneumatic compression device (PCD). It also aims to assess efficacy of PCD and MLD and assess compliance of treatment in both groups. Lastly, it aims to identify voice and swallowing changes in both groups.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, AZ

Closed-enrolling by invitation
What is this? (?)
View complete study & contact information

Print study details
Site IRB:
21-003342

NCT ID:
NCT05512767

Sponsor Protocol Number:
21-003342

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, AZ	Closed-enrolling by invitation What is this? (?)	View complete study & contact information

A Study To Evaluate MRTX849 In Patients With Advanced Solid Tumors With KRAS G12C Mutation

Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN

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A Study To Evaluate MRTX849 In Patients With Advanced Solid Tumors With KRAS G12C Mutation

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
1/2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of this study is to characterize the safety and tolerability of MRTX849 in patients having advanced solid tumor malignancies with KRAS G12C mutation.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, AZ	Closed for enrollment	View complete study & contact information
Jacksonville, FL	Closed for enrollment
Rochester, MN	Closed for enrollment

Print study details

Site IRB:
20-001187
NCT ID:
NCT03785249
Sponsor Protocol Number:
849-001

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Search Results 1201-1210 of 2572

A Study To Assess Adult Allogeneic Expanded Adipose-derived Stem Cells (EASC) For The Treatment Of Complex Perianal Fistula(s) In Patients With Crohn's Disease

A Study To Evaluate The Safety Of Bb2121 In Subjects With High Risk, Newly Diagnosed Multiple Myeloma (NDMM) (KarMMa-4)

A Study To Evaluate Intravenous Iloprost In Subjects With Symptomatic Raynaud's Phenomenon Secondary To Systemic Sclerosis

A Study To Assess The Efficacy And Safety Of H.P. Acthar® Gel In The Treatment Of Subjects With Amyotrophic Lateral Sclerosis

Use Of F-652 In Patients With Alcoholic Hepatitis

A Study To Determine The Effects Of A Mechanical Device To Treat Swelling Of The Face And Neck Following Treatment For Cancer.

A Study To Evaluate MRTX849 In Patients With Advanced Solid Tumors With KRAS G12C Mutation

An Open Label Study To Examine The Effects Of DAS181 Administered By Dry Powder Inhaler (DPI) Or Nebulized Formulation In Immunocompromised Subjects With Parainfluenza (PIV) Infection

A Multicenter Assessment Of LBR-101 In High Frequency Episodic Migraine

A Randomized Phase 2 Trial Of Axitinib And TRC105 Versus Axitinib Alone In Patients With Advanced Or Metastatic Renal Cell Carcinoma

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