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NCT ID: NCT01896102 Completed - Clinical trials for Cerebral Adrenoleukodystrophy (CALD)

A Study of the Efficacy and Safety of Hematopoietic Stem Cells Transduced With Lenti-D Lentiviral Vector for the Treatment of Cerebral Adrenoleukodystrophy (CALD)

Start date: August 21, 2013
Phase: Phase 2/Phase 3
Study type: Interventional

This trial assessed the efficacy and safety of autologous cluster of differentiation 34 (CD34+) hematopoietic stem cells, transduced ex-vivo with Lenti-D lentiviral vector (also called elivaldogene autotemcel or eli-cel), for the treatment of cerebral adrenoleukodystrophy (CALD). A participant's blood stem cells were collected and modified (transduced) using the Lenti-D lentiviral vector encoding human adrenoleukodystrophy protein. After modification (transduction) with the Lenti-D lentiviral vector, the cells were transplanted back into the participant following myeloablative conditioning. Participants in this study will be continuously followed in study LTF-304.

NCT ID: NCT01895777 Completed - Clinical trials for Venous Thromboembolism

Open Label Study Comparing Efficacy and Safety of Dabigatran Etexilate to Standard of Care in Paediatric Patients With Venous Thromboembolism (VTE)

Start date: September 25, 2013
Phase: Phase 3
Study type: Interventional

The main objectives of this large phase IIb/III paediatric study are to assess the efficacy and safety of dabigatran etexilate relative to standard of care and to document the appropriateness of the proposed dabigatran etexilate dosing algorithm for use in patients from birth to less than 18 years of age.

NCT ID: NCT01894516 Completed - Clinical trials for Rheumatoid Arthritis

Dose-finding Study of GLPG0634 as Monotherapy in Active Rheumatoid Arthritis (RA) Participants (DARWIN2)

Start date: October 8, 2013
Phase: Phase 2
Study type: Interventional

- Participants suffering from active rheumatoid arthritis who had an inadequate response to methotrexate were evaluated for improvement of disease activity (efficacy) when taking GLPG0634 as monotherapy (3 different doses - 50 milligram (mg), 100 mg and 200 mg once daily) or matching placebo for 24 weeks. - During the course of the study, patients were also examined for any side effects that could occur (safety and tolerability), and the amount of GLPG0634 present in the blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood (Pharmacodynamics) were determined. Also, the effects of different doses of GLPG0634 administration on participants' disability, fatigue and quality of life were evaluated.

NCT ID: NCT01894022 Completed - Hypertension Clinical Trials

A Open Label Study to Assess the Long-term Safety, Tolerability and Efficacy of Ambrisentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

AMBER II
Start date: January 2014
Phase: Phase 3
Study type: Interventional

This is an open label, long term extension to Study AMB115811. All subjects may remain in the extension study for a minimum of 18 months. Beyond the 18-month period, subjects may continue in the extension study until one of the following: - The product is approved locally for use in inoperable CTEPH patients; - Development for use in the CTEPH population is discontinued or product is not approved by the local regulatory authorities - The investigator decides to discontinue the subject or subject decides to discontinue from the study. The primary purpose of this study is to provide clinically relevant information on the long term safety of ambrisentan in subjects with inoperable CTEPH.

NCT ID: NCT01892436 Completed - Psoriatic Arthritis Clinical Trials

Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis

FUTURE 1 ext
Start date: September 30, 2013
Phase: Phase 3
Study type: Interventional

This study was designed as a 3-year extension to the phase III core study CAIN457F2306. It aimed to provide continuous treatment with secukinumab in pre-filled syringes (PFS) for subjects who completed the core study CAIN457F2306, to obtain further long term efficacy, safety and tolerability information in subjects with active psoriatic arthritis receiving secukinumab every 4 weeks. At Week 104 of the study CAIN457F2306, eligible subjects completed the assessments associated with the core study visit and subsequently continued in this extension study on the same dose that they were receiving during the core study. The regular assessments of disease activity ensure that subjects who are experienced worsening of disease in any of the treatment groups could exit the study upon their own wish or based on the advice of the investigator at any time.

NCT ID: NCT01892345 Terminated - Clinical trials for Neuromyelitis Optica

A Randomized Controlled Trial of Eculizumab in AQP4 Antibody-positive Participants With NMO (PREVENT Study)

Start date: April 11, 2014
Phase: Phase 3
Study type: Interventional

The objectives of this time-to-event study were to assess the efficacy and safety of eculizumab as compared with placebo in participants with neuromyelitis optica spectrum disorder (NMOSD) who were anti-aquaporin-4 (AQP4) antibody-positive.

NCT ID: NCT01890473 Completed - Clinical trials for Rheumatoid Arthritis

Study to Characterize the Pharmacokinetics of a Single Dose of SC Abatacept 125 mg Using the BD Autoinjector or the Prefilled Syringe

Start date: July 2013
Phase: Phase 1
Study type: Interventional

The primary purpose of the protocol is to describe the pharmacokinetics of a single dose of Abatacept 125 mg in Rheumatoid Arthritis patients delivered via the autoinjector device or the approved prefilled syringe.

NCT ID: NCT01889030 Completed - Clinical trials for Cardiovascular Primary Prevention

Cardiovascular Risk Stratification of Ambulatory Patients in Primary Prevention

RISK
Start date: July 2013
Phase: N/A
Study type: Observational [Patient Registry]

This is an observational, cross-sectional, national multicenter study, trying to obtain local data about the global cardiovascular risk profile of patients attending ambulatory offices of general practitioners and cardiologists. The aim of the study is to describe how physicians diagnose and stratify their patients in cardiovascular primary prevention setting and to highlight if patients are stratify through objective tools (risk scores and in this case, wich of them are used) or in subjective ways (clinical evaluation).

NCT ID: NCT01888874 Completed - Clinical trials for Rheumatoid Arthritis

Dose-finding Study of GLPG0634 as add-on to Methotrexate in Active Rheumatoid Arthritis Participants (DARWIN1)

DARWIN1
Start date: July 17, 2013
Phase: Phase 2
Study type: Interventional

Participants suffering from active rheumatoid arthritis despite continued treatment with methotrexate were evaluated for improvement of disease activity (efficacy) when taking GLPG0634 (3 different doses - 50 milligram [mg], 100 mg and 200 mg daily -, each evaluated as once daily [QD] and twice daily [BID] regimen) or matching placebo for 24 weeks. •During the course of the study, patients were also examined for any side effects that could occur (safety and tolerability), and the amount of GLPG0634 present in the blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood (Pharmacodynamics) were determined. Also, the effects of different doses and dose regiments of GLPG0634 administration on participants' disability, fatigue, and quality of life were evaluated.

NCT ID: NCT01887639 Completed - Clinical trials for Non-psychotic Unipolar Major Depression

Prevalence and Risk Factors in Unipolar Depression Patients Without Remission After One Antidepressant Trial

PANTHER
Start date: September 2013
Phase: N/A
Study type: Observational [Patient Registry]

A non interventional, descriptive, longitudinal cohort study is designed, trying to obtain local data about the prevalence of non remitted depressed patients after an antidepressant treatment, and to get information about sociodemographic and clinical characteristics of these patients as well as features of their treatments and compare them with those of the patients that achieve remission. Also the effect of patient´s expectation in the treatment outcome will be examined.