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NCT ID: NCT04160065 Active, not recruiting - Clinical trials for Merkel Cell Carcinoma

Immunotherapy With IFx-Hu2.0 Vaccine for Advanced Non-melanoma Skin Cancers

Start date: March 3, 2020
Phase: Phase 1
Study type: Interventional

In this clinical phase I, non-randomized, open-label, uncontrolled, interventional, multi-center trial, 20 adult subjects (≥ 18 years of age) with advanced non-melanoma skin cancers will receive a fixed dose of 0.1 mg of IFx-Hu2.0 intralesionally as monotherapy in up to three lesions at up to three time points. Subjects will be observed for any acute adverse events (AEs) post injection and for any delayed AEs at Day 28, 35 and/or 42 ± 7 days, depending on the cohort (exposure escalation and expansion design).

NCT ID: NCT04159415 Active, not recruiting - Clinical trials for Generalized Lipodystrophy

Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized Lipodystrophy

Start date: January 7, 2020
Phase: Phase 2
Study type: Interventional

The primary objectives of the study are to estimate the effects of REGN4461 on glycemic parameters in the subset of patients with elevated baseline hemoglobin A1c levels (HbA1c ≥7%) and to estimate the effects of REGN4461 on fasting triglyceride levels in the subset of patients with elevated baseline fasting triglycerides (TG ≥250 mg/dL). The secondary objectives are to estimate the effects of REGN4461 on a composite endpoint of changes in either HbA1c or fasting TG for all patients, estimate the effects of 3 dose levels of REGN4461 on glycemic parameters and fasting TG, to estimate the effects of REGN4461 on insulin sensitivity, to evaluate the safety and tolerability of REGN4461 and to evaluate the pharmacokinetics (PK) and immunogenicity of REGN4461.

NCT ID: NCT04158934 Active, not recruiting - Hemophilia A Clinical Trials

A Long-term Study of ADYNOVI/ADYNOVATE in Participants With Haemophilia A

Start date: July 9, 2020
Phase:
Study type: Observational

The main aim of this study is to check for long-term side effects from ADYNOVI/ADYNOVATE prophylaxis in participants with haemophilia A when used under standard clinical practice in the real-world clinical setting.

NCT ID: NCT04158739 Active, not recruiting - Clinical trials for Refractory Acute Myeloid Leukemia

Flotetuzumab for the Treatment of Pediatric Recurrent or Refractory Acute Myeloid Leukemia

Start date: January 22, 2020
Phase: Phase 1
Study type: Interventional

This phase I trial studies the side effects, best dose of flotetuzumab and how well it works in treating patients with acute myeloid leukemia (AML) that has come back (recurrent) or has not responded to treatment (refractory). This study also determines the safest dose of flotetuzumab to use in children with AML. As an immunotherapy, flotetuzumab may also cause changes in the body's normal immune system, which are also under study in this trial.

NCT ID: NCT04158648 Active, not recruiting - Hemophilia A Clinical Trials

A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Emicizumab in Participants With Mild or Moderate Hemophilia A Without FVIII Inhibitors

HAVEN 6
Start date: February 10, 2020
Phase: Phase 3
Study type: Interventional

This is a multicenter, open-label, single-arm study designed to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of emicizumab in participants with mild or moderate hemophilia A without inhibitors against factor VIII (FVIII).

NCT ID: NCT04158297 Active, not recruiting - Clinical trials for Chronic Pancreatitis

ESWL Versus SOPIL for Treatment of Pancreatic Duct Stones

Start date: November 13, 2019
Phase: N/A
Study type: Interventional

Pancreatic duct stones can cause obstruction of the main pancreatic duct leading to abdominal pain, exocrine pancreatic insufficiency, and recurrent acute pancreatitis. By removing pancreatic duct stones, the obstruction can be relieved, and this can improve symptoms. Small stones can be removed with standard endoscopic retrograde cholangiopancreatography (ERCP) and stone removal, but larger stones may require lithotripsy to break up the stone before removal. The two current methods of lithotripsy include extracorporeal shock wave lithotripsy (ESWL) and single operator pancreatoscopy with intracorporeal lithotripsy (SOPIL). ESWL is based on concentrating shock wave energy to the stone through an external device. SOPIL is a newer technique based on direct visualization of the stone during ERCP and targeting the stone with a shock wave catheter. There are currently no studies directly comparing ESWL to SOPIL for breaking apart stones in the pancreatic duct, so this study is designed to compare the two techniques. Objective #1: Obtain pilot data to determine the optimal method of clearing large MPDS Objective #2: Obtain pilot data to assess how effective large MPDS clearance is in improving long term patient centered outcomes Objective #3: Obtain pilot data to measure the cost effectiveness of large MPDS clearance

NCT ID: NCT04157348 Active, not recruiting - Clinical trials for Eosinophilic Granulomatous Vasculitis

Efficacy and Safety of Benralizumab in EGPA Compared to Mepolizumab.

MANDARA
Start date: October 29, 2019
Phase: Phase 3
Study type: Interventional

This is a randomized, double blind, active-controlled, parallel group, multicenter 52-week Phase 3 study to compare the efficacy and safety of benralizumab 30 mg versus mepolizumab 300 mg administered by subcutaneous (SC) injection in patients with relapsing or refractory EGPA on corticosteroid therapy with or without stable immunosuppressive therapy. All patients who complete the 52-week double-blind treatment period on IP may be eligible to continue into an open label extension (OLE) period. The OLE period is intended to allow each patient at least 1 year of treatment with open-label benralizumab 30 mg administered SC (earlier enrolled patients may therefore be in the OLE for longer than 1 year).

NCT ID: NCT04157335 Active, not recruiting - Nasal Polyposis Clinical Trials

Efficacy and Safety Study of Benralizumab in Patient With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps (ORCHID)

ORCHID
Start date: November 25, 2019
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, parallel-group, international, multicenter, Phase 3 study to evaluate the efficacy and safety of repeat dosing of benralizumab 30 mg administered subcutaneously (SC) versus placebo in patients with severe nasal polyposis.

NCT ID: NCT04157322 Active, not recruiting - Clinical trials for Colorectal Cancer Metastatic

Plasma 5hmC Signatures as a Marker of Colorectal / Appendiceal Peritoneal Metastasis

Start date: August 26, 2019
Phase:
Study type: Observational

Patients with peritoneal metastasis of colorectal or high grade appendiceal origin who are candidates for cytoreductive surgery with HIPEC (hyperthermic intraperitoneal chemotherapy) will be enrolled in this study. Blood collection for measurements of plasma cell-free DNA hydroxymethylation signatures will be performed at different time points, before and after surgery, in order to determine if plasma hydroxymethylation signatures are more sensitive than conventional tumor markers in identifying clinically detectable recurrence at 1 year after surgery.

NCT ID: NCT04156347 Active, not recruiting - Retinoblastoma Clinical Trials

Topotecan Episcleral Plaque for Treatment of Retinoblastoma

Start date: June 16, 2021
Phase: Phase 1
Study type: Interventional

This single-arm, non-randomized, dose escalation phase I clinical trial will assess primarily the safety and secondarily the efficacy of episcleral topotecan in patients with active de novo or recurrent intraocular retinoblastoma in at least one eye following completion of first-line therapy.