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NCT ID: NCT03799536 Recruiting - Bioequivalence Clinical Trials

Bioequivalence Study of Sotalol, Tablets, 160 mg (Pharmtechnology LLC, Belarus), and Sotalex®, Tablets, 160 mg (Bristol-Myers Squibb GmbH& CО. KGaA, Germany), in Healthy Volunteers Under Fasting Conditions

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

This is an open-label, randomized, single-center, single-dose, two-treatment, two-sequence, two-period, crossover, comparative study, where each subject was randomly assigned to the reference or the test formulation in each period of the study (sequences RT or TR), in order to evaluate if both formulations are bioequivalent.The study was conducted in multiple groups.

NCT ID: NCT03695978 Recruiting - Haemophilia A Clinical Trials

Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia A Patients

Start date: February 13, 2018
Study type: Observational

International, post-authorisation non-interventional study to evaluate real-life effectiveness, safety and utilisation patterns of Octapharma's FVIII concentrates Nuwiq, Octanate, and Wilate in previously untreated and minimally treated severe haemophilia A patients in routine clinical practice.

NCT ID: NCT03687255 Recruiting - Clinical trials for Urinary Tract Infections

Safety and Efficacy Study of Cefepime-AAI101 in the Treatment of Complicated Urinary Tract Infections

Start date: September 24, 2018
Phase: Phase 3
Study type: Interventional

Multi-center, randomized, double-blind, non-inferiority study of cefepime 2 g/AAI101 500 mg combination compared to piperacillin 4 g/tazobactam 500 mg in a population of adult patients with cUTI or AP. The study will be conducted in approximately 115 sites located in the EU, the US, Central, South America and South Africa.

NCT ID: NCT03653026 Recruiting - Clinical trials for Ulcerative Colitis (UC)

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis

Start date: October 29, 2018
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the efficacy and safety of Upadacitinib compared to placebo in inducing clinical remission (per Adapted Mayo score) in subjects with moderately to severely active ulcerative colitis (UC).

NCT ID: NCT03619252 Enrolling by invitation - Multiple Myeloma Clinical Trials

Pneumococcal Vaccination of Multiple Myeloma Patients on Novel Agents

Start date: July 1, 2018
Phase: Phase 4
Study type: Interventional

Multiple myeloma is an incurable blood cancer of plasma cells that occurs in older individuals. Novel agents (proteasome inhibitors, immunomodulatory agents) have substantially improved the overall response rates, progression-free survival and overall survival in patients with multiple myeloma. Patients with multiple myeloma are at high risk of developing life-threatening Streptococcus pneumoniae infections, while clinical efficacy and safety of conjugate pneumococcal vaccines in multiple myeloma patients receiving novel agents have not been studied before. The main aim of this study is to assess the clinical efficacy and safety of 13-valent pneumococcal conjugate vaccine in multiple myeloma patients treated with novel agents.

NCT ID: NCT03598751 Recruiting - Psoriatic Arthritis Clinical Trials

Clinical Study of Efficacy and Safety of BCD-085 (Monoclonal Anti-IL-17 Antibody) in Psoriatic Arthritis

Start date: September 10, 2018
Phase: Phase 3
Study type: Interventional

Study BCD-085-8/PATERA is a multicentre double-blind placebo-controlled Phase 3 study in patients with psoriatic arthritis (PsA). The objective of the study is to evaluate the efficacy and safety of BCD-085 comparing to placebo in patients with PsA.

NCT ID: NCT03556358 Recruiting - Breast Cancer Clinical Trials

Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer

Start date: June 28, 2018
Phase: Phase 3
Study type: Interventional

This is a Phase III, double-blind, randomized, multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of TX05 (trastuzumab) with Herceptin® in subjects with HER2 positive early breast cancer.

NCT ID: NCT03519243 Active, not recruiting - Anemia Clinical Trials

Comparative Study of the Efficacy and Safety of BCD-131 and Mircera in Treatment of Anemia in CKD Patients on Dialysis

Start date: October 24, 2017
Phase: Phase 2
Study type: Interventional

BCD-131 is pegylated darbepoetin beta. BCD-131-2 is International Multicenter Randomized Open-Label Comparative Study (Phase II) of the Efficacy and Safety of BCD-131 and Mircera in Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis.

NCT ID: NCT03492177 Recruiting - Clinical trials for Pulmonary Arterial Hypertension

A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension

Start date: July 25, 2018
Phase: Phase 2
Study type: Interventional

Selexipag is available for the treatment of pulmonary arterial hypertension (PAH) in adults in various countries. The efficacy of selexipag to delay disease progression was shown in a previous pivotal study conducted in 1156 adult patients with PAH. Given the similarities in the functional changes of PAH in children and adults, it is expected that children suffering from PAH could benefit from treatment with selexipag. The aim of the present study is to confirm the doses of selexipag to be used in pediatric patients with PAH older than 2 years. To fulfill this aim, blood levels of selexipag (pharmacokinetic assessments) as well as the safety, and tolerability of selexipag in children with PAH will be assessed.

NCT ID: NCT03473743 Recruiting - Clinical trials for Urothelial Carcinoma

A Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Erdafitinib Plus JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Participants With Metastatic or Surgically Unresectable Urothelial Cancer With Selected FGFR Gene Alterations

Start date: April 5, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to identify the recommended Phase 2 dose (RP2D) and schedule of erdafitinib in combination with JNJ-63723283 (Phase 1b) and to evaluate the safety and clinical activity of erdafitinib alone and in combination with JNJ-63723283 (Phase 2).