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NCT ID: NCT04064827 Recruiting - Clinical trials for Chronic Kidney Disease (CKD)

A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD)

Start date: September 16, 2020
Phase: Phase 3
Study type: Interventional

The main objective of this study is to evaluate the safety, efficacy and pharmacokinetics of paricalcitol oral solution in pediatric participants of ages 0 to 9 years with SHPT associated with stage 5 CKD receiving Peritoneal Dialysis (PD) or Hemodialysis (HD). The 24-week study is divided into two 12-week dosing periods (Dosing Period 1 followed by Dosing Period 2).

NCT ID: NCT04064411 Completed - Clinical trials for Postmenopausal Osteoporosis

Efficacy & Safety of Abaloparatide-Solid Microstructured Transdermal System in Postmenopausal Women With Osteoporosis

Start date: August 5, 2019
Phase: Phase 3
Study type: Interventional

A 12-month study to compare the efficacy and safety of abaloparatide-solid microstructured transdermal system (sMTS) with abaloparatide-subcutaneous (SC).

NCT ID: NCT04059484 Active, not recruiting - Clinical trials for Breast Cancer Metastatic

Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer

AMEERA-3
Start date: October 22, 2019
Phase: Phase 2
Study type: Interventional

Primary Objective: To determine whether amcenestrant per overall survival (os) improves progression free survival (PFS) when compared with an endocrine monotherapy of the choice of the physician, in participants with metastatic or locally advanced breast cancer Secondary Objectives: - To compare the overall survival in the 2 treatment arms - To assess the objective response rate in the 2 treatment arms - To evaluate the disease control rate in the 2 treatment arms - To evaluate the clinical benefit rate in the 2 treatment arms - To evaluate the duration of response in the 2 treatment arms - To evaluate the PFS according to the estrogen receptor 1 gene (ESR1) mutation status in the 2 treatment arms - To evaluate the pharmacokinetics of amcenestrant as single agent - To evaluate health-related quality of life in the 2 treatment arms - To compare the overall safety profile in the 2 treatment arms

NCT ID: NCT04052516 Completed - Clinical trials for Non Alcoholic Steatohepatitis (NASH)

A Phase 2b Study of Icosabutate in Fatty Liver Disease

ICONA
Start date: July 17, 2019
Phase: Phase 2
Study type: Interventional

A Phase 2b study to evaluate the efficacy of different doses of NST-4016 on the resolution of NASH without worsening of fibrosis

NCT ID: NCT04048135 Completed - NASH Clinical Trials

A Multiple Ascending Dose Study of Pegozafermin in Participants With Biopsy Confirmed Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) and at High Risk of NASH

Start date: July 29, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Part 1: This is a multi-center evaluation of pegozafermin (administered weekly or every other week) in a randomized, double-blind, placebo-controlled study administered for 12 weeks in participants with NASH and NAFLD at high risk of NASH, including a pre-defined number of participants with biopsy confirmed NASH and fibrosis stages F1-F3 to be enrolled. Part 2: This is a multi-center, open label evaluation of pegozafermin at 27 mg administered weekly for 20 weeks in participants with biopsy-proven NASH (NAS ≥4, fibrosis stage F2 or F3).

NCT ID: NCT04039607 Active, not recruiting - Clinical trials for Hepatocellular Carcinoma

A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma

CheckMate 9DW
Start date: September 30, 2019
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to compare the overall survival (OS) of nivolumab plus ipilimumab versus standard of care (SOC) (sorafenib or lenvatinib) in all randomized participants with advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

NCT ID: NCT04039503 Completed - Type 2 Diabetes Clinical Trials

A Study of Tirzepatide (LY3298176) Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin

SURPASS-5
Start date: August 30, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the safety and efficacy of the study drug tirzepatide to placebo in participants with type 2 diabetes that are already on insulin glargine, with or without metformin. Participants will administer tirzepatide or placebo along with their previous glucose lowering medications. The study will last approximately 47 weeks and may include about 23 visits.

NCT ID: NCT04036435 Active, not recruiting - Psoriasis Clinical Trials

Long-Term Study That Measures the Safety and Efficacy of Deucravacitinib (BMS-986165) in Participants With Psoriasis

POETYK PSO-LTE
Start date: August 12, 2019
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to characterize the long-term safety and efficacy of the drug Deucravacitinib (BMS-986165) in patients who have been previously enrolled in an applicable Phase 3 psoriasis study.

NCT ID: NCT04031885 Terminated - Clinical trials for Metastatic Breast Cancer

A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer

Start date: August 14, 2019
Phase: Phase 4
Study type: Interventional

The reason for this study is to compare the efficacy of abemaciclib, in combination with fulvestrant, to that of physician's choice of chemotherapy in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer that has spread to internal organs. Your participation in this trial could last up to 31 months, depending on your cancer type and how you and your tumor respond.

NCT ID: NCT04027387 Completed - HIV-1-infection Clinical Trials

Dose Escalation Safety Study of TMB-365 in HIV-1 Infected Participants

Start date: December 14, 2019
Phase: Phase 1
Study type: Interventional

This study will evaluate the safety and behavior in the body of the experimental drug TMB-365 in people with HIV-1 infection. This will be the first test of TMB-365 in humans. One dose of the study drug is given to each participant, followed by 10 weeks of monitoring for safety and levels of the drug in the blood. The first group of participants will receive the lowest dose (400 mg). If no safety concerns are seen, the next group will begin at a higher dose (800 mg). If no safety concerns are seen in the second group, the third group will begin at the highest dose in this study (1600 mg).