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NCT ID: NCT02870972 Recruiting - Clinical trials for Hereditary Angioedema (HAE)

Efficacy and Safety of BCX7353 to Prevent Angioedema Attacks in Subjects With Hereditary Angioedema

APeX-1
Start date: August 2016
Phase: Phase 2
Study type: Interventional

This 3-part study will evaluate the safety and efficacy of an oral treatment, BCX7353, in preventing angioedema attacks in subjects with hereditary angioedema (HAE). In Part 1 of the study, eligible subjects will be randomized to receive oral BCX7353 or placebo for 4 weeks. Assuming successful completion of Part 1, additional subjects will be randomized in Part 2 to one of 2 lower doses of BCX7353 or placebo. Part 3 will enroll additional subjects into one of three doses of BCX7353 or placebo. The study will compare the number of acute attacks in each treatment group, as well as a number of other clinical and pharmacologic outcomes, and the safety and tolerability of each dose of BCX7353 compared to placebo.

NCT ID: NCT02828683 Active, not recruiting - Clinical trials for Acute ST Segment Elevation Myocardial Infarction

Safety and Efficacy of TCD-10023 (Ultimaster) Drug-eluting Stent in STEMI Patients - MASTER Study

MASTER
Start date: July 2013
Phase: N/A
Study type: Interventional

The aim of the study is to demonstrate the safety and efficacy of the TCD-10023 (Ultimaster) sirolimus eluting stent in patients with acute ST-elevation myocardial infarction (STEMI), by proving superiority with respect to in-stent late loss at 6 months to the Kaname bare metal stent and non-inferiority with respect to Target Vessel Failure (TVF) at 12 months.

NCT ID: NCT02663323 Recruiting - Clinical trials for Coronary Artery Disease

Pilot Clinical Study of MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System

MeRes-1 Extend
Start date: February 2016
Phase: Phase 2/Phase 3
Study type: Interventional

MeRes-1 Extend study is designed as prospective, multinational, multicentre, single arm, open label, pilot study to assess the safety and performance of the MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System (BRS) in subjects with de novo native coronary artery lesions. 64 subjects will be enrolled from the 8 centers located in Asia Pacific, Europe, Brazil and South Africa. Primary outcome of study will be Proportion of population reporting Major Adverse Cardiac Events at 6 months from the day of index Procedure.

NCT ID: NCT02620566 Completed - Anesthesia Clinical Trials

Caudal Block vs Local Wound Infiltration for Hernia Repair in Children

CBvsLWI
Start date: September 2015
Phase: Phase 1/Phase 2
Study type: Interventional

To our knowledge there is still no study comparing the local wound infiltration by itself without ilio-inguinal and ilio-hypogastric nerve block and caudal anesthesia. The aim of this study was to evaluate anesthesia and recovery profile in pediatric patients after inguinal hernia repair with caudal block (CB) or local wound infiltration (LWI).

NCT ID: NCT02518620 Recruiting - Clinical trials for Rheumatoid Arthritis

An Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects With Rheumatoid Arthritis

Start date: July 2015
Phase: Phase 2
Study type: Interventional

The objective of this study is to evaluate the long-term efficacy and safety of ALX-0061 administered subcutaneously (s.c.) to subjects with active Rheumatoid Arthritis (RA).

NCT ID: NCT02514447 Recruiting - Clinical trials for Small Cell Lung Cancer

Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Patients With Previously Treated Extensive Stage SCLC Receiving Topotecan Chemotherapy

Start date: July 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor efficacy when administered prior to topotecan in patients previously treated for extensive-stage SCLC. The study consists of 2 parts: a limited open-label, dose-finding portion (Part 1), and a randomized double-blind portion (Part 2). Both parts include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. The open-label portion enrolled 32 patients and the randomized portion will enroll approximately 60 patients.

NCT ID: NCT02380170 Recruiting - Urosepsis Clinical Trials

Epidemiology and Outcomes of Gram Negative Urosepsis

SERPENS
Start date: September 2014
Phase: N/A
Study type: Observational

The study aims to get an insight on the causative bacteria of sepsis derived from the urinary tract. Furthermore, it is the intention to understand the outcomes of these patients. For this purpose a non-interventional, observational study will be conducted.

NCT ID: NCT02309359 Completed - Clinical trials for Rheumatoid Arthritis

A Dose-Range Finding Study for ALX-0061 Combination Therapy in Subjects With Rheumatoid Arthritis

Start date: January 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of dose regimens of ALX-0061 administered subcutaneously (s.c.) in combination with methotrexate (MTX) to subjects with active RA despite MTX therapy, compared with placebo. To assess the effects of ALX-0061 on quality of life, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ALX-0061, and to define the optimal dose regimen for ALX-0061, based on safety and efficacy, for further clinical development.

NCT ID: NCT02287922 Completed - Clinical trials for Rheumatoid Arthritis

A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis

Start date: February 2015
Phase: Phase 2
Study type: Interventional

The primary objective of this study is: - To assess the efficacy and safety of dose regimens of ALX-0061 monotherapy administered subcutaneously (s.c.) to subjects with active rheumatoid arthritis (RA). The secondary objectives of this study are: - To assess the effects of ALX-0061 on quality of life, the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ALX 0061 and to explore potential dose regimens for ALX 0061 monotherapy, based on safety and efficacy, for further clinical development. - To obtain parallel descriptive information concerning the efficacy and safety of tocilizumab (TCZ) s.c. in the same clinical trial RA population.

NCT ID: NCT02247739 Completed - Clinical trials for Hereditary Angioedema

A Phase 2 HAE Prophylaxis Study With Recombinant Human C1 Inhibitor

Start date: December 2014
Phase: Phase 2
Study type: Interventional

Primary Objective: To evaluate the efficacy of recombinant human C1 inhibitor (rhC1INH) in the prophylaxis of angioedema attacks in patients with HAE Secondary Objective: To evaluate the safety and immunogenicity of recombinant human C1 inhibitor (rhC1INH) in the prophylaxis of angioedema attacks in patients with HAE