| BREATHID Octanoate Breath Test With or Without Methacetin Breath Test for Correlation With Biopsy in NASH | Clinical Study of the BreathID® System to Train the Algorithm for the ¹³C-Octanoate Breath Test With or Without the ¹³C-Methacetin Breath Test (OBT and MBT Respectively) for Correlation With Histological Findings Associated With Non-Alcoholic Steatohepatitis (NASH) and Other Liver Diseases | NCT02314026 |
| A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis exacerbations. All patients will receive a single dose course of IGIV-C treatment followed by 28-days of post-infusion assessments. | A multicenter, prospective, open-label, non-controlled clinical trial to assess the efficacy and safety of Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in patients with Myasthenia Gravis exacerbations | EUCTR2013-005098-28-CZ |
| A study investigating Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 8 (Week 21). | A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ Chromatography Purified (IGIV -C) in Symptomatic Subjects with Generalized Myasthenia Gravis | EUCTR2014-003997-18-LT |
| A study investigating Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis, dependent on Corticosteroids. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 13 (Week 36). During maintenance doses the investigator will try to slowly reduce the patient's corticosteroid dose. | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ chromatography Purified (lGIV -C) as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients with Generalized Myasthenia Gravis | EUCTR2013-005099-17-LT |
| A Randomized Controlled Comparative Trial of Long-Acting Neuraminidase Inhibitor Laminavir Octanoate versus Zanamivir Hydrate in Influenza Virus Infection | A Randomized Controlled Comparative Trial of Long-Acting Neuraminidase Inhibitor Laminavir Octanoate versus Zanamivir Hydrate in Influenza Virus Infection - A Randomized Controlled Comparative Trial of Long-Acting Neuraminidase Inhibitor Laminavir Octanoate versus Zanamivir | JPRN-UMIN000004903 |
| A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-ARM STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF INHALED LANINAMIVIR OCTANOATE TWINCAPS® DRY POWDER INHALER IN ADULTS WITH SYMPTOMATIC INFLUENZA A OR B INFECTION | A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-ARM STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF INHALED LANINAMIVIR OCTANOATE TWINCAPS® DRY POWDER INHALER IN ADULTS WITH SYMPTOMATIC INFLUENZA A OR B INFECTION | PER-032-13 |
| Safety & Pharmacokinetics Study of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Children With Influenza | Randomised, Parallel Dose, Phase 1/2 Safety and Pharmacokinetics Study of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Children With Naturally Acquired Influenza A or B | NCT02014649 |
| Efficacy and Safety Study of Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults With Influenza | A Phase 2 Randomized, Double Blind, Placebo Controlled, Parallel Arm Study to Investigate the Efficacy and Safety of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults With Symptomatic Influenza A or B Infection | NCT01793883 |
| Detection of Hepatocellular Carcinoma (HCC) With Octanoate Breath ID Test Compared to MRI | Evaluation of the Capability of the ¹³C-Octanoate Breath Test (OBT) Measurement in Patients With Chronic Liver Disease to Differentiate Between Presence and Absence of HCC Determined by MRI | NCT01433016 |
| Prediction of Severity of Liver Disease Non Alcoholic Fatty Liver Disease in Patients With Suspected NAFLD by a 13C Octanoate Breath Test | | NCT01281059 |
| Prediction of Severity of Liver Disease by a 13C Octanoate Breath Test (OBT) | Prediction of Severity of Liver Disease in Patients With Suspected Nonalcoholic Fatty Liver Disease (NAFLD) by 13C Octanoate Breath Test (OBT) | NCT01244503 |
| Determination of HCC With Octanoate Breath Test vs. MRI Diagnosis | Evaluation of the Capability of the ¹³C-Octanoate Breath Test (OBT) Measurement to Differentiate Between Presence and Absence of HCC Determined by MRI in Patients With Chronic Liver Disease | NCT02794805 |
| Safety, Tolerability and Pharmacokinetics of Inhaled Laninamivir Octanoate TwinCaps® DPI in Adults With Chronic Asthma | A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Inhaled Laninamivir Octanoate in Adults With Chronic Asthma | NCT02022761 |
| A Dose-finding and Feasibility Study for a Prolonged 13C-octanoate Breath Test for Gastric Emptying | A Dose-finding and Feasibility Study for a Prolonged 13C-octanoate Breath Test for Gastric Emptying During Continuous Nutrient Infusion | NCT03410147 |
| OBT Measurement to Differentiate Between Presence and Absence of HCC Determined by MRI | Evaluation of the Capability of the ¹³C-Octanoate Breath Test (OBT) Measurement to Differentiate Between Presence and Absence of HCC Determined by MRI in Patients With Chronic Liver Disease | NCT02415283 |
