A5371: A Single-Arm, Open-Label, Pilot Study of Semaglutide for Non-Alcoholic Fatty Liver Disease (NAFLD), a Metabolic Syndrome with Insulin Resistance, Increased Hepatic Lipids, and Increased Cardiovascular Disease Risk (The SLIM LIVER Study)About 30-40% of people living with HIV have a condition called NAFLD, or non-alcoholic fatty liver disease. NAFLD is caused by high levels of stored fat in the liver. Most people with NAFLD also have other complications like high cholesterol, obesity, increased belly fat or type 2 diabetes. These complications can lead to cardiovascular disease (any disease of the heart or blood vessels that can lead to a stroke or heart attack). In fact, most of the health problems that are associated with NAFLD are related to these conditions of the heart or metabolism. Without treatment, NAFLD can advance to more serious liver disease. By using a drug that can lower the level of stored fat in the liver, people living with HIV may be able to treat NAFLD and reduce their risk of cardiovascular disease and other complications. Protocol #: 19-2824 Location: University of Colorado Hospital |
Alpha lipoic acid to decrease treatment related pain and side effects during concurrent chemoradiation in HNSCCProtocol #: 19-1081 Location: University of Colorado Hospital |
The Laboratory for Advanced Medicine (LAM) / Prospective Clinical Trial to Detect Liver Cancer through Quantification of cfDNA Methylation in Blood Samples (CLiMB)Protocol #: 19-1272 Location: University of Colorado Hospital |
A Phase 3, Randomized, Double-blind Study of Adjuvant Nivolumab versus Placebo for Participants with Hepatocellular Carcinoma Who Are at High Risk of Recurrence after Curative Hepatic Resection or AblationProtocol #: 19-0820 Location: University of Colorado Hospital |
A Multi-Center, Open-Label, Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anticancer Activity of Fruquintinib in Patients with Advanced Solid Tumors of any Type, and in Patients with Refractory Metastatic Colorectal CancerProtocol #: 19-0539 Location: University of Colorado Hospital |
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Non-Cirrhotic Subjects with Primary Sclerosing CholangitisProtocol #: 19-0444 Location: University of Colorado Hospital |
Pilot Study of Dynamic Contrast Enhanced Computed Tomography (DCE-CT) Imaging for the assessment of radiation therapy outcome for liver cancer patientsProtocol #: 18-2874 Location: University of Colorado Hospital |
A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C MutationProtocol #: 18-2529 Location: University of Colorado Hospital |
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Trial of Oral IW-3718 Administered to Patients with Gastroesophageal Reflux Disease while receiving Proton Pump InhibitorsThe Treatment Period begins with treatment assignment and lasts for 8 weeks. Patients will be stratified by whether they have, or do not have, erosive esophagitis on the screening EGD, and by their baseline heartburn severity level (average heartburn severity score over the last 7 days prior to randomization of <3 vs. ≥3; see Criteria for Evaluation, below) and randomly assigned within each stratum to placebo or 1500 mg IW-3718 BID (1:1). The treatment randomization schedule will be managed by a central vendor. Enrollment will be monitored to ensure that no single center contributes > 10% of the targeted study enrollment, unless otherwise approved by the Medical Monitor. Study drug will be taken immediately after the morning and evening meals. Patients will continue to take their PPI approximately 30-60 minutes before breakfast each day and to use the eDiary to provide their daily assessments (GERD symptoms and assessment of sleep), weekly assessments (degree of relief of GERD symptoms, symptom bothersomeness, and treatment satisfaction questions). At the end of the treatment period study medication will be discontinued and patients will return for an End-of-Treatment (EOT) Visit. All patients who have erosive esophagitis (LA classification A-D) on EGD at Screening and completed ≥4 weeks of treatment will have a repeat EGD at their EOT Visit. Patients will also complete all End-of-Treatment assessments Protocol #: 18-2021 Location: University of Colorado Hospital |
EA2165 A Randomized Phase II Study of Nivolumab after Combined Modality Therapy (CMT) in High Risk Anal CancerProtocol #: 18-1216 Locations: Greeley Hospital; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital; Poudre Valley Hospital; University of Colorado Hospital |
An Open-label, Single-arm, Phase 1b Study to Evaluate the Safety and Efficacy of Grapiprant (ARY-007) in Combination with Pembrolizumab in Patients with Advanced or Progressive Microsatellite Stable (MSS) Colorectal Cancer (CRC)Protocol #: 18-1431 Location: University of Colorado Hospital |
A Randomized Phase 2 Study of Losartan and Nivolumab in Combination With FOLFIRINOX and SBRT in Localized Pancreatic CancerProtocol #: 18-1347 Location: University of Colorado Hospital |
A 5-year Longitudinal Observational Study of Patients with Nonalcoholic Fatty Liver or Nonalcoholic Steatohepatitis 14DEC2016TARGET-NASH encompasses a unique retrospective/prospective longitudinal cohort design that will define the natural history of NASH, establish important patient level baseline disease characteristics against which to judge subsequent interventions, and evaluate the safety and effectiveness of novel therapies as they are utilized in the post-marketing environment. Protocol #: 17-0051 Location: University of Colorado Hospital |
A Multicenter, Double-Blind, Parallel-Arm, Placebo-Controlled Phase 2 Study of the Efficacy, Safety, and Tolerability of Oral Full-Spectrum Microbiota? (CP101) in Subjects with Recurrence of Clostridium difficile Infection (2/22/2018 version 3)This is a double-blind, placebo-controlled, parallel-arm, multicenter study comparing the safety, tolerability, and efficacy of CP101 treatment relative to placebo in adults with previously treated recurrent CDI. Subjects who are experiencing recurrent CDI will undergo screening procedures. Subjects who meet eligibility criteria will be randomized to study drug. Approximately 200 subjects (100 subjects per treatment group) will be randomized in a 1:1 ratio to receive CP101 (6 1011 bacteria) or placebo. The treatment duration will be 1 day, including active drug (CP101) and placebo. Subjects will be monitored for recurrence of CDI, safety, and tolerability for 24 weeks following Randomization. The primary efficacy and safety endpoints will be evaluated at 8 weeks post-treatment, and all subjects will continue to be followed for an additional 16 weeks for safety and recurrence of CDI. To qualify for the study, subjects must be experiencing recurrent CDI defined as: a) 3 episodes of CDI, with 2 episodes occurring within the previous 12 months (inclusive of the current episode); OR b) 2 episodes of CDI occurring within the previous 6 months (inclusive of the current episode) AND 65 years of age or older. Additionally, to qualify, recurrent CDI subjects must have received standard-of-care CDI antibiotics for the most recent CDI episode (for 10-21 days, with exact duration, antibiotic type, and dose at the discretion of the Investigator) and have an adequate clinical response, defined as 3 unformed stools in 24 hours for 2 or more consecutive days immediately prior to Randomization. Protocol #: 18-1166 Location: University of Colorado Hospital |
An Observational Cohort Study of the Use of Avatrombopag in Patients with Thrombocytopenia Associated with Chronic Liver Disease Undergoing a ProcedureProtocol #: 18-1144 Location: University of Colorado Hospital |
Prospective, Multi-center, Randomized Controlled Study Comparing Endoscopic Clearance of Non-Complex Biliary Stones Using Fluoroscopy/Radiation-Free Direct Solitary Cholangioscopy (DSC) to Standard of Care Endoscopic Retrograde Cholangiography (ERC)Protocol #: 18-1137 Location: University of Colorado Hospital |
Title: PRO-ACT: Prevention of De Novo HCV with Antiviral HCV Therapy Post-Liver and Post-Kidney TransplantProtocol #: 18-0559 Location: University of Colorado Hospital |
Precision Approach to PPI Therapy in Gastroesophageal reflux diseaseOver the past 25 years, RALS has been increasingly, and often incorrectly, diagnosed and has emerged as a point of controversy and confusion. Despite the limitations of current diagnostic tests and therapeutic strategies, recent advances in gastoresophageal reflux disease offer tremendous potential for RALS diagnosis and treatment. Newer diagnostic tools are able to assess physiologic properties of RALS. Thus, this study will address three crucial gaps impacting the clinical approach to RALS: 1) Paucity of diagnostic tests that predict clinically relevant outcomes, 2) undefined clinical role of UES augmentation, and 3) deficiency or cost-effective and personalized approaches. Protocol #: 18-0205 Location: University of Colorado Hospital |
A Multicenter, Single-Arm Study of Endoscopic Ultrasound-Guided Drainage of Walled-off Pancreatic Necrosis with Lumen-Apposing Metal StentsThe purpose of this study is to determine if a newer type of metal stent with a plastic covering, called the AXIOSTM stent, is safe and effective in draining your WON. Protocol #: 18-0442 Location: University of Colorado Hospital |
Phase II study of pembrolizumab in combination with binimetinib and bevacizumab in patients with refractory colorectal cancerProtocol #: 17-0466 Location: University of Colorado Hospital |
An Open-Label, Multicenter and Open Enrollment Model, Postmarketing, Milk-Only Lactation Study to Assess Concentration of Vedolizumab in Breast Milk of Lactating Women With Active Ulcerative Colitis or Crohn's Disease Who Are Receiving Vedolizumab TherapeuticallyThe safety of medications to treat UC and CD during pregnancy and lactation is of significant interest of childbearing potential, as these medications may be transferred in utero or though breast milk form nursing mothers to their newborns. It is unknown whether vedolizumab is present in human breast milk. Protocol #: 16-0066 Location: University of Colorado Hospital |
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Emricasan, an Oral Caspase Inhibitor, in Subjects with Decompensated Non-Alcoholic Steatohepatitis (NASH) CirrhosisProtocol #: 18-0153 Location: University of Colorado Hospital |
A Randomized, Open-label, Phase 2 Study to Evaluate Safety and Efficacy of DUR-928 in Subjects with Primary Sclerosing Cholangitis (PSC)DUR-928 (investigational drug) Protocol #: 18-0123 Location: University of Colorado Hospital |
An Open-Label, Dose Escalation, Phase 1, First-in-Human Study of TAK-164, an Antibody-Drug Conjugate, in Patients with Advanced Gastrointestinal Cancers Expressing Guanylyl Cyclase CProtocol #: 17-2226 Location: University of Colorado Hospital |
A Proof-of-Concept and Dose-Ranging Study Investigating the Efficacy and Safety of HTD1801 in Adult Subjects with Primary Sclerosing Cholangitis (PSC)Protocol #: 17-2367 Location: University of Colorado Hospital |
A Phase 2 Study of Cabiralizumab (BMS-986227, FPA008) Administered in Combination with Nivolumab (BMS-936558) with and without Chemotherapy in Patients with Advanced Pancreatic CancerProtocol #: 17-2189 Location: University of Colorado Hospital |
S1613: A RANDOMIZED PHASE II STUDY OF TRASTUZUMAB AND PERTUZUMAB (TP) COMPARED TO CETUXIMAB AND IRINOTECAN (CETIRI) IN ADVANCED/METASTATIC COLORECTAL CANCER (MCRC) WITH HER-2 AMPLIFICATIONProtocol #: 17-2125 Locations: Greeley Hospital; Highlands Ranch Hospital; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
A021502: Randomized Trial of Standard Chemotherapy Alone or Combined with Atezolizumab as Adjuvant Therapy for Patients with Stage III Colon Cancer and Deficient DNA Mismatch RepairProtocol #: 17-2036 Locations: Greeley Hospital; Highlands Ranch Hospital; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
Open Label, Randomized, Multicenter, Comparative Effectiveness Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission in Patients with Crohn's Disease v:5.0; March 20, 2018Protocol #: 17-0019 Location: University of Colorado Hospital |
Copeptin and Nonalcoholic Fatty Liver DiseaseSee above Protocol #: 17-1160 Locations: Anschutz Health and Wellness; UCD Anschutz Health & Wellness Center; University of Colorado Hospital |
The Colonic Microbiome and Mucosal Immunity in Inflammatory Bowel Disease and Ankylosing SpondylitisThis study uses colonic biopsies to compare immune cell function and gut microbiome between those with IBD, AS, AS/IBD overlap, and healthy controls. To evaluate the relationship between the colonic microbiome and the immune system in AS, IBD, AS+IBD, and healthy controls. Protocol #: 14-1507 Locations: Colorado Research Center; Denver Health Medical Center; University of Colorado Hospital |
A Phase IA/IB Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of RO7198457 as a Single Agent and in Combination with Atezolizumab in Patients with Locally Advanced or Metastatic TumorsProtocol #: 17-0991 Location: University of Colorado Hospital |
Therapeutic modulation of the intestinal creatine kinase system in inflammatory bowel disease (IBD)Specific Aim 1: Determine whether creatine supplementation induces improvement in the endoscopic assessment of mucosal inflammation in ulcerative colitis (UC). Specific Aim 2: Evaluate the feasibility of the current study protocol. Specific Aim 3: Assess the impact of creatine supplementation on intestinal epithelial barrier function and the intestinal microbiome. Protocol #: 13-3054 Location: University of Colorado Hospital |
Procurement of Blood Samples from Subjects with Diagnosed Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) for Use in the Development of a Liver Fibrosis Test V: Jan 20 2017Protocol #: 17-0571 Location: University of Colorado Hospital |
Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohns Disease V: 05 March 2018Protocol #: 16-2456 Location: University of Colorado Hospital |