Clinical Trials Sponsored by Tolera Therapeutics, Inc

Total 3005 results

Tolera Therapeutics, Inc

Unknown

Evaluating Safety and Efficacy of TOL101 Induction Versus Anti-Thymocyte Globulin to Prevent Kidney Transplant Rejection

End Stage Renal Disease | Renal Transplant

United States
Galera Therapeutics, Inc.

Terminated

Phase I/II Study of SBRT and GC4711 for Centrally Located or Large NSCLC (GRECO-1)

NSCLC | SBRT | Non-metastatic

United States
Galera Therapeutics, Inc.

Completed

ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients

Oral Mucositis

United States, Puerto Rico, Canada
Galera Therapeutics, Inc.

Completed

Ph 2 Open Label Study of GC4419 to Reduce SOM Associated With Chemoradiotherapy for Head and Neck Cancer

Head and Neck Cancer | Oral Mucositis

Spain, Switzerland, Belgium, Poland, Germany, Czechia
Galera Therapeutics, Inc.

Terminated

A Trial of GC4419 in Patients With Critical Illness Due to COVID-19

Covid19 | SARS-CoV-2 Infection

United States
Galera Therapeutics, Inc.

Completed

A Study of the Effects of GC4419 on Radiation Induced Oral Mucositis in Patients With Head/Neck Cancer

Radiation Induced Oral Mucositis

United States, Canada, Puerto Rico
Tobira Therapeutics, Inc.

Completed

ORION: Effects of Cenicriviroc on Insulin Sensitivity in Subjects With Prediabetes or Type 2 Diabetes Mellitus (T2DM) and Suspected NAFLD

Type 2 Diabetes Mellitus | Prediabetic State | Non-alcoholic Fatty Liver Disease

United States, Puerto Rico
Tobira Therapeutics, Inc.

Completed

Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Participants With Liver Fibrosis (CENTAUR)

Nonalcoholic Steatohepatitis

Belgium, Spain, Hong Kong, United States, France, Germany, Australia, United Kingdom, Poland, Italy
Galera Therapeutics, Inc.

Completed

A Phase 1 Dose Escalation Study of GC4419 in Combination With Chemoradiation for Squamous Cell Cancer of the Head & Neck

Squamous Cell Carcinoma of the Oral Cavity | Squamous Cell Carcinoma of the Oropharynx

United States
Galera Therapeutics, Inc.

Terminated

Phase 2b Study of GC4711 in Combination With SBRT for Nonmetastatic Pancreatic Cancer

Unresectable Pancreatic Cancer | Borderline Resectable Pancreatic Cancer | SBRT

United States, France, United Kingdom, Canada
Tobira Therapeutics, Inc.

Terminated

Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Participants With Nonalcoholic Steatohepatitis

Liver Cirrhosis | Non-alcoholic Fatty Liver Disease | Nonalcoholic Steatohepatitis

United States, Australia, France, Germany, Spain, Poland, United Kingdom, Italy, Puerto Rico, Belgium, Hong Kong
Galera Therapeutics, Inc.

Completed

A Phase 1 Study of the Safety and Pharmacokinetics of GC4711 (Oral Capsule) Compared to GC4419 (IV Infusion) and GC4711 (IV Infusion) in Healthy Volunteers

Healthy Volunteers

Australia
Galera Therapeutics, Inc.

Completed

A Study Designed to Evaluate the Safety and Pharmacokinetics of Intravenously Administered Superoxide Dismutase Mimetic GC4711 in Healthy Volunteers

Healthy

Australia
Galera Therapeutics, Inc.

Completed

Study to Evaluate the Effects of 90 mg Intravenous Infusions of GC4419 on the Single Dose Pharmacokinetics of Dextromethorphan in Healthy Adult Subjects

Healthy

United States
Tobira Therapeutics, Inc.

Completed

PERSEUS: Preliminary Efficacy and Safety of Cenicriviroc in Adult Participants With Primary Sclerosing Cholangitis

Primary Sclerosing Cholangitis

United States, Canada
Tobira Therapeutics, Inc.

Completed

Pharmacokinetic and Safety Study of Cenicriviroc and Acid Reducing Agents When Dosed Alone or in Combination

Healthy

United States
Tobira Therapeutics, Inc.

Completed

Pharmacokinetic and Safety Study of Cenicriviroc and Pioglitazone, When Dosed Alone or in Combination

Healthy

United States
Tobira Therapeutics, Inc.

Completed

A Proof of Concept Study to Evaluate the Antiviral Activity, Safety, and Pharmacokinetics of the CCR5 Antagonist TBR 652 in HIV 1-Infected, Antiretroviral Treatment-Experienced, CCR5 Antagonist-Naïve Patients

HIV-1 Infection
Galera Therapeutics, Inc.

Terminated

Effects of Intravenous GC4419 on the Incidence and Severity of Esophagitis Due to Chemoradiotherapy for Lung Cancer

Esophagitis

United States
Galera Therapeutics, Inc.

Completed

Study to Evaluate the Effects of Renal Impairment on the Pharmacokinetics, Safety and Tolerability of GC4419

Renal Impairment

United States
Tobira Therapeutics, Inc.

Terminated

AURORA: A Study for the Efficacy and Safety of Cenicriviroc (CVC) for the Treatment of Liver Fibrosis in Adults With Nonalcoholic Steatohepatitis (NASH) (AURORA)

Nonalcoholic Steatohepatitis

United States, Spain, Australia, Belgium, Israel, Canada, Puerto Rico, Italy, Germany, France, New Zealand, Taiwan, Poland, United Kingdom, Brazil, Austria, Singapore, Portugal, Chile, Greece, Hong Kong, Hungary, Latvia, Mexico, Norway, R... and more
Tobira Therapeutics, Inc.

Completed

Pharmacokinetic and Safety Study of Cenicriviroc and HMG-CoA Reductase Inhibitors, Caffeine and Digoxin

Healthy

United States
Tobira Therapeutics, Inc.

Completed

Phase 1 Study of Multiple-Dose Pharmacokinetics of Cenicriviroc in Subjects With Mild and Moderate Hepatic Impairment

Liver Insufficiency

United States
Tobira Therapeutics, Inc.

Completed

Efficacy, Safety, and Tolerability of Cenicriviroc (CVC) in Combination With Truvada or Sustiva Plus Truvada in HIV 1-infected, Antiretroviral Treatment-naïve, Adult Patients Infected With Only CCR5-tropic Virus

HIV-1 Infection

United States, Puerto Rico
Galera Therapeutics, Inc.
Celerion

Completed

A Study to Investigate the Absorption, Metabolism, Excretion, and Mass Balance of GC4419 in Healthy Adult Subjects

Healthy | Healthy Volunteers

United States
Ocera Therapeutics, Inc.

Completed

OCR002-SP103 - Oral Immediate Release Study

Cirrhosis

United States
Ocera Therapeutics, Inc.

No longer available

Emergency Use of OCR-002 in Acute Liver Failure (ALF)

Acute Liver Failure

United States
Ocera Therapeutics, Inc.

Completed

Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE) (STOP-HE)

Hepatic Encephalopathy | Acute Episode of Overt Hepatic Encephalopathy

Belgium, Germany, Italy, Spain, United States, France, Austria, Russian Federation, Czechia, Australia, Hungary, Israel, Netherlands, Bulgaria, Estonia, Denmark, New Zealand
Galera Therapeutics, Inc.
Syneos Health

Completed

A Study Designed to Compare the Safety and Pharmacokinetics of Intravenously Administered Superoxide Dismutase Mimetic GC4711 and GC4419 in Healthy Volunteers

Healthy | Healthy Volunteers

Australia
Galera Therapeutics, Inc.
Syneos Health

Completed

A Phase 1, Randomized, Placebo-and Positive-Controlled Crossover Study to Determine the Effect of Single-Dose GC4419 on QTc Interval in Healthy Volunteers

Healthy | Healthy Volunteers

Australia
Tobira Therapeutics, Inc.
ViiV Healthcare

Completed

Study of Dolutegravir (DTG) on PK of Cenicriviroc (CVC), and CVC on PK of DTG & on a Single Dose of Midazolam

HIV-infection/AIDS

United States
Ocera Therapeutics

Completed

Safety and Efficacy of AST-120 in the Treatment of Pouchitis

Pouchitis

United States
Ocera Therapeutics

Terminated

Safety and Efficacy of AST-120 in Patients With GERD Who Continue to be Symptomatic on a Standard Dose of PPI

Gastroesophageal Reflux Disease (GERD)

United States
Ocera Therapeutics

Terminated

Safety and Efficacy of AST-120 in the Treatment of Antibiotic-Refractory Pouchitis

Pouchitis

United States
University of Hawaii
Tobira Therapeutics, Inc.

Completed

Effect of Cenicriviroc on HIV Neurocognitive Impairment

AIDS Dementia Complex | Human Immunodeficiency Virus | HIV-1-Associated Cognitive Motor Complex

United States
Ocera Therapeutics

Completed

AST-120 Used to Treat Mild Hepatic Encephalopathy (ASTUTE)

Mild Hepatic Encephalopathy

United States
Ocera Therapeutics

Completed

Safety and Efficacy of AST-120 in Patients With Non-Constipating Irritable Bowel Syndrome

Irritable Bowel Syndrome

United States, Belgium
Ocera Therapeutics

Completed

Safety and Efficacy of AST-120 in Mild to Moderate Crohn's Patients With Fistulas

Intestinal Fistula | Inflammatory Bowel Disease

United States, Israel, Canada, United Kingdom, Germany, Belgium, Hungary, France, Austria, Czech Republic, Netherlands, Poland
Ocera Therapeutics

Completed

Safety and Efficacy of AST-120 Compared to Lactulose in Patients With Hepatic Encephalopathy (AST015)

Hepatic Encephalopathy

United States
Galera Therapeutics, Inc.
M.D. Anderson Cancer Center

Completed

Pilot Dose Escalation Trial of Stereotactic Body Radiation Therapy (SBRT) in Combination With GC4419 in Pancreatic Cancer

Pancreatic Cancer | Stereotactic Body Radiation Therapy

United States
University of California, San Francisco
Tobira Therapeutics, Inc.

Terminated

Investigation of The Effect of Cenicriviroc (CVC) Plus FTC/TDF on Cardiovascular Disease Risk Factors

HIV Infection

United States
Galera Therapeutics, Inc.
INC Research Australia Pty Ltd; Nucleous Network

Completed

A Study of the Safety, Tolerability and Pharmacokinetics of Orally-administered GC4702 in Healthy Volunteers

Healthy Volunteer

Australia
Tolmar Inc.

Recruiting

Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer (OVELIA)

Breast Cancer

United States, Mexico, Brazil, Canada, Puerto Rico, Argentina
Tolmar Inc.

Enrolling by invitation

Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study

Breast Cancer

United States, Puerto Rico
Cotera, Inc.

Terminated

Evaluation of the Latella™ Knee Implant System for Medial Osteoarthritis Pain Reduction (Latella-US)

Osteoarthritis

United States
Cotera, Inc.

Terminated

Feasibility of the Latella Implant System for Medial Osteoarthritis (OA)

Osteoarthritis

Netherlands, United Kingdom
Tolmar Inc.

Completed

Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty

Precocious Puberty, Central

United States, Canada, Argentina, Chile, Mexico, New Zealand
Tolmar Inc.

Completed

BE Study of Calcipotriene Hydrate and Betamethasone Dipropionate Topical Suspension in the Treatment of Scalp Psoriasis

Scalp Psoriasis

United States
Cotera, Inc.

Terminated

Evaluation of the Latella Knee Implant System for Medial Osteoarthritis Pain Reduction (Latella-2 Study)

Osteoarthritis

Netherlands, United Kingdom, Spain
Cohera Medical, Inc.

Completed

Clinical Evaluation of Cohera Sylys Surgical Sealant as an Adjunct to Standard Bowel Anastomosis Closure

Stoma Reversal Procedure

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