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NCT ID: NCT04271475 Terminated - Clinical trials for Chronic Thromboembolic Pulmonary Hypertension

A Study to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension

MACiTEPH
Start date: July 7, 2020
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the effect of macitentan 75 mg versus placebo on exercise capacity at Week 28 in participants with chronic thromboembolic pulmonary hypertension (CTEPH).

NCT ID: NCT04252430 Terminated - Healthy Volunteers Clinical Trials

RI Study to Assess and Compare the Pharmacokinetic Parameters of MD1003 in Renal Impaired Patients and Healthy Subjects

Start date: October 9, 2019
Phase: Phase 1
Study type: Interventional

This is a Phase 1, multicentric, open-label,two arms to assess and compare the effect of single oral administration of MD1003 on the pharmacokinetic parameters in renal impaired patients and healthy subjects with normal renal function. The planned enrollment is 36 subjects (18 impaired patients and 18 healthy subjects).

NCT ID: NCT04252417 Terminated - Healthy Volunteers Clinical Trials

HI Study to Assess and Compare the Pharmacokinetic Parameters of MD1003 in Hepatic Impaired Patients and Healthy Subjects

Start date: October 11, 2019
Phase: Phase 1
Study type: Interventional

This is a Phase 1, multicentric, open-label,two arms to assess and compare the effect of single oral administration of MD1003 on the pharmacokinetic parameters in hepatic impaired patients and healthy subjects with normal hepatic function. The planned enrollment is 16 subjects (8 impaired patients and 8 healthy subjects).

NCT ID: NCT04225897 Terminated - Clinical trials for Respiratory Syncytial Virus (RSV)

A Study to Learn About the Effects of Sisunatovir in Infants With Respiratory Syncytial Virus Lower Respiratory Tract Infection.

REVIRAL 1
Start date: November 13, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (sisunatovir). Sisunatovir is developed as potential treatment of Respiratory Syncytial Virus (RSV) infections. This study will assess sisunatovir as compared to placebo in infants aged 1 month to 36 months who are hospitalized with RSV lower respiratory tract infection (LRTI). A placebo looks like the study medicine but does not contain any active medicine in it. This study will be conducted in 3 parts: In Part A participants aged 6 months to 3 years will be given a single dose of 2.5 mg/kg of sisunatovir in Cohort 1. In Cohort 2, participants age 1 month to 6 months will receive a single dose of 2 mg/kg of sisunatovir only after the completion of Cohort 1. 12-24 participants will be enrolled in Part A In Part B participants age 1 month to 36 months will receive sisunatovir or placebo dosed every 12 hours for 5 days. Doses for part B will be determined after the completion of Part A. 24-40 participants will be enrolled in Part B. The dose regimen for Part C will be determined after the completion of Part B. Approximately 120 participants age 1 month to 36 months will receive either sisunatovir or placebo. To participate in this study participants must meet the following criteria: 1. Age 1 month to 36 months 2. Weight ≥ 3.5 kg 3. Diagnosis of LRTI 4. Diagnosis of RSV 5. Hospitalization due to RSV LRTI

NCT ID: NCT04210843 Terminated - Clinical trials for Chronic Spontaneous Urticaria

Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab

Start date: April 8, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this extension study was to establish efficacy and safety of ligelizumab. This was assessed in adult and adolescent chronic spontaneous urticaria (CSU) patients who had completed a preceding ligelizumab study and have relapsed, following treatment in these preceding studies, despite standard of care H1-antihistamine (H1-AH) treatment. This study also fulfilled the Novartis commitment to provide post-trial access to patients who had completed studies: CQGE031C2302 (NCT03580369), CQGE031C2303 (NCT03580356), CQGE031C2202 (NCT03437278) or CQGE031C1301 (NCT03907878).

NCT ID: NCT04209179 Terminated - Hypoparathyroidism Clinical Trials

A Clinical Study Investigating the Safety, Tolerability, PK and PD of PCO371 in Patients With Hypoparathyroidism

Start date: July 23, 2020
Phase: Phase 1
Study type: Interventional

This is a multi-center, placebo-controlled, randomized, double-blind, multiple-ascending dose study in patients with hypoparathyroidism. The total duration of study medication treatment will be 13 weeks and includes a Fixed-Dose Treatment period and a Dose Titration Treatment period. The Fixed-Dose Treatment period consists of multiple daily dosing at a fixed dose level. Once patients have completed the Fixed-Dose Treatment period, patients will enter the Dose Titration Treatment period where PCO371 (or placebo), oral calcium and oral active vitamin D can each be titrated according to the patient's albumin-corrected serum calcium level.

NCT ID: NCT04200456 Terminated - Clinical trials for Primary Immune Thrombocytopenia

A Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)

myOpportunITy1
Start date: January 31, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the clinical efficacy of rozanolixizumab in maintenance treatment and assess safety and tolerability of rozanolixizumab in adult study participants with primary immune thrombocytopenia (ITP).

NCT ID: NCT04163900 Terminated - Clinical trials for Biliary Tract Cancer

Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Advanced Biliary Tract Cancer

Start date: December 24, 2019
Phase: Phase 3
Study type: Interventional

NuTide:121 compares NUC-1031 with gemcitabine, both in combination with cisplatin, in patients with previously untreated advanced biliary tract cancer. The primary hypotheses are: - The combination of NUC-1031 plus cisplatin prolongs overall survival compared to the gemcitabine plus cisplatin standard of care - The combination of NUC-1031 plus cisplatin increases overall response rate compared to the gemcitabine plus cisplatin standard of care

NCT ID: NCT04162470 Terminated - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria

REGN3918 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) to Evaluate Its Long Term Safety, Efficacy and Tolerability.

Start date: December 3, 2019
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to evaluate the long-term safety, tolerability, and effect on intravascular hemolysis of REGN3918 in patients with paroxysmal nocturnal hemoglobinuria (PNH). The secondary objectives of the study are: - To evaluate the long-term effect of REGN3918 on intravascular hemolysis - To assess the concentrations of total REGN3918 in serum - To evaluate the occurrence of the immunogenicity of REGN3918

NCT ID: NCT04126031 Terminated - Clinical trials for Gram-negative Bacterial Infection

Evaluation of Pharmacokinetics, Safety, and Tolerability of Ceftazidime-avibactam in Neonates and Infants.

NOOR
Start date: January 14, 2020
Phase: Phase 2
Study type: Interventional

This study will assess the pharmacokinetics, safety, and tolerability of single and multiple doses of intravenous ceftazidime-avibactam in hospitalized infants and neonates from 26 weeks gestation to 3 months of age. In Part A of the study all patients will receive a single dose of ceftazidime-avibactam. In Part B all patients will received multiple doses of ceftazidime-avibactam. Efficacy will be assessed in the infants and neonates receiving multiple doses of ceftazidime-avibactam.