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NCT ID: NCT04353791 Completed - Clinical trials for Ulcerative Colitis Chronic Moderate

Study of OST-122 in Patients With Moderate to Severe Ulcerative Colitis

Start date: September 16, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

A Phase Ib/IIa to evaluate the safety and tolerability of oral treatment with OST-122 in patients with moderate to severe ulcerative colitis over 28 days. This trial will also explore pharmacokinetics (PK) profile and preliminary therapeutic efficacy associated with OST-122 through biomarker analysis and clinical, endoscopic and histologic assessments.

NCT ID: NCT04345900 Completed - Clinical trials for Chemotherapy-induced Neutropenia

Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy Phase 2

Start date: April 5, 2017
Phase: Phase 2
Study type: Interventional

To assess the duration of severe neutropenia (DSN) in treatment Cycle 1 in patients treated with docetaxel (75 mg/m2) + plinabulin (5, 10, or 20 mg/m2) or with docetaxel (75 mg/m2) + pegfilgrastim (6 mg). Neutrophils count was to be assessed at baseline (prior to Cycle 1 docetaxel dose) and during Cycle 1 on Days 1, 2, 6, 7, 8, 9, 10, and 15 (pre-dose on dosing days; times equivalent to pre dose on other days).

NCT ID: NCT04338061 Terminated - Clinical trials for Relapsing Multiple Sclerosis

Study of Evobrutinib in Participants With RMS (evolutionRMS 2)

Start date: July 2, 2020
Phase: Phase 3
Study type: Interventional

The study is to evaluate the efficacy and safety of evobrutinib administered orally twice daily versus Teriflunomide (Aubagio®), administered orally once daily in participants with Relapsing Multiple Sclerosis (RMS). Participants who complete the double-blind treatment period (DBTP) and double-blind extension period (DBEP) prior to approval of a separate long-term follow-up study in their country will get an option for evobrutinib treatment continuation through a 96-week open-label extension (OLE) period.

NCT ID: NCT04338022 Terminated - Clinical trials for Relapsing Multiple Sclerosis

Study of Evobrutinib in Participants With RMS (evolutionRMS 1)

Start date: June 12, 2020
Phase: Phase 3
Study type: Interventional

The study is to evaluate the efficacy and safety of evobrutinib administered orally twice daily versus Teriflunomide (Aubagio®), administered orally once daily in participants with Relapsing Multiple Sclerosis (RMS). Participants who complete the double-blind treatment period (DBTP) and double-blind extension period (DBEP) prior to approval of a separate long-term follow-up study in their country will get an option for evobrutinib treatment continuation through a 96-week open-label extension (OLE) period.

NCT ID: NCT04335591 Completed - Endometriosis Clinical Trials

Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain (EDELWEISS 6)

Start date: March 5, 2020
Phase: Phase 3
Study type: Interventional

The primary objective of this extension study is to assess the maintenance of efficacy of linzagolix administered orally once daily for up to an additional 6 months (for up to 12 months of treatment in total) in women who have already completed 6 months of linzagolix treatment at a dose of 75 mg alone or of 200 mg in combination with ABT (E2 1 mg / NETA 0.5 mg), in the management of moderate to severe endometriosis-associated pain (EAP) in women with surgically confirmed endometriosis.

NCT ID: NCT04335539 Completed - Sepsis Clinical Trials

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants

Start date: August 21, 2020
Phase: Phase 2
Study type: Interventional

The primary objectives of this study are: - To assess the safety and tolerability of cefiderocol after single-dose administration in hospitalized paediatric participants 3 months to < 18 years of age with suspected or confirmed aerobic Gram-negative bacterial infections - To assess the pharmacokinetics (PK) of cefiderocol after single-dose administration of cefiderocol in hospitalized paediatric participants 3 months to < 18 years of age with suspected or confirmed aerobic Gram-negative bacterial infections - To assess the safety and tolerability of cefiderocol after multiple-dose administration in hospitalized paediatric participants 3 months to < 12 years of age with suspected or confirmed aerobic Gram-negative bacterial infections - To assess the PK of cefiderocol after multiple-dose administration in hospitalized paediatric participants 3 months to < 12 years of age with suspected or confirmed aerobic Gram-negative bacterial infections

NCT ID: NCT04333147 Terminated - Clinical trials for Arthritis, Rheumatoid

Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA)

contRAst X
Start date: May 12, 2020
Phase: Phase 3
Study type: Interventional

RA is a chronic, systemic inflammatory autoimmune disease which requires treatment for a long time period, hence it is important to study the long-term safety and efficacy of the continuous treatment with GSK3196165 over several years. This is a Phase 3, multicenter, parallel group treatment and long-term extension study primarily to assess safety with efficacy assessment as a secondary objective. Adult participants with RA who have completed the treatment phase of a qualifying GSK3196165 clinical studies (Phase 3 studies contRAst 1 (201790: NCT03980483), contRAst 2 (201791: NCT03970837) and contRAst 3 (202018: NCT04134728) and who, in investigator's judgement will benefit from extended treatment with GSK3196165 will be included in this study (contRAst X [209564: NCT04333147]). Participants will continue to receive the same background conventional synthetic disease modifying anti-rheumatic drug(s) [csDMARD(s)] treatment as they received in their qualifying study. Eligible participants will be enrolled to receive weekly GSK3196165 90 milligrams (mg) or 150 mg by subcutaneous (SC) injection. The anticipated study duration is approximately 4 years which will enable participants to receive treatment with GSK3196165 until it is expected to become commercially available. Approximately 3000 participants from the qualifying studies will participate in this long-term extension study

NCT ID: NCT04333108 Recruiting - Clinical trials for Indolent Systemic Mastocytosis

Masitinib in Severe Indolent or Smoldering Systemic Mastocytosis Unresponsive to Optimal Symptomatic Treatment

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

The purpose of this study is to evaluate the efficacy and safety of oral masitinib versus placebo in the treatment of patients suffering from smouldering or indolent systemic mastocytosis with severe symptoms of mast cell mediator release, unresponsive to optimal symptomatic treatment.

NCT ID: NCT04317729 Completed - Clinical trials for Hepatitis C Virus Infection

DBS Evaluation of Fujirebio INNOTEST® HCV Ab IV

Start date: January 30, 2020
Phase: N/A
Study type: Interventional

The goal of this trial is to evaluate the performance of the Fujirebio INNOTEST® HCV Ab IV using simpler collection methods such as fingerstick and venous whole blood collection on dried blood spots (DBS). In order to assess performance in samples with high and low antibody titres, performance will be evaluated with undiluted samples of all trial participants and serial diluted samples for a subset of HCV antibody reactive samples. Serial dilution of reactive samples will provide further insights into the potential difference of sensitivity in samples collected on DBS versus plasma. Results of this trial will also support the update of the regulatory claims to include DBS as an alternative sample type.

NCT ID: NCT04295434 Recruiting - Blood Pressure Clinical Trials

Blood Pressure Control in ESH Excellence Centres

BP-CON
Start date: October 1, 2018
Phase:
Study type: Observational

In the BP-CON-ESH study we are going to include and analyze treated hypertensive patients seen consecutively by the ESH Excellence Centres. Blood pressure will be measured as usually done in the office, but care will be adopted to make measurements highly standardized in all Centres. The primary goals will be to determine the global, regional and country rates of hypertension control in Europe. Other goals will be to identify global and regional factors associated with blood pressure control in different European regions. The results obtained in the BP-CON-ESH project will be used to refine treatment strategies for improvement of blood pressure control and will serve as a basis for assessing future changes and trends in Europe.