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NCT ID: NCT02416661 Completed - Gaucher Disease Clinical Trials

Lyso-Gb1 as a Long-term Prognostic Biomarker in Gaucher Disease

LYSO-PROOF
Start date: August 27, 2018
Phase:
Study type: Observational

International, multicenter, epidemiological study to demonstrate the correlation and predictive value of lyso-Gb1 concentration with the clinical severity of naïve, initially non-ERT/SRT Gaucher disease type 1 and during the study ERT/SRT-newly started Gaucher type 1 patients and to correlate lyso-Gb1 concentration with the clinical improvement of ERT or SRT treated Gaucher type 1 and the clinical course of non-treated patients based on GD-DS3

NCT ID: NCT01825512 Completed - Clinical trials for Chronic Iron Overload

Efficacy/Safety Study of Deferiprone Compared to Deferasirox in Paediatric Patients

Start date: March 17, 2014
Phase: Phase 3
Study type: Interventional

Multicentre, randomised, open label, non-inferiority active-controlled trial to evaluate efficacy and safety of a 12-months treatment with deferiprone (DFP) at dose of 75-100 mg/kg/day versus deferasirox (DFX) at dose of 20-40 mg/kg/day in paediatric patients (1 month < 18 years old) affected by hereditary haemoglobinopathies and requiring frequent transfusions and chelation.

NCT ID: NCT01712763 Completed - Endometriosis Clinical Trials

Degarelix in the Treatment of Endometriosis Recurrence

Start date: November 2012
Phase: Phase 3
Study type: Interventional

The long acting GnRH antagonist degarelix will be tested for the treatment of women with endometriosis recurrence compared with classical GnRH analog treatment. Pain symptom disappearance and disease free time during follow-up will be the outcomes for establishing which medical treatment is the best in endometriosis recurrence treatment.

NCT ID: NCT01566721 Completed - Breast Neoplasms Clinical Trials

A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer

SafeHER
Start date: May 17, 2012
Phase: Phase 3
Study type: Interventional

This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and tolerability of assisted and self-administered SC Herceptin as adjuvant therapy in participants with early HER2-positive breast cancer following tumor excision. Participants will receive Herceptin 600 milligrams (mg) SC every 3 weeks for 18 cycles, either by an assisted administration using a conventional syringe and needle/vial formulation (Cohort A) or with assisted and self-administration using a single-use injection device (SID) in selected participants (Cohort B).

NCT ID: NCT01491100 Completed - Multiple Sclerosis Clinical Trials

Noninterventional Study Assessing Cognitive Function and Physical Activity in People With Multiple Sclerosis

CogniPlus
Start date: April 30, 2012
Phase:
Study type: Observational

Study assessing cognitive function and physical activity in people with relapsing remitting multiple sclerosis.

NCT ID: NCT01461928 Completed - Clinical trials for Non-Hodgkin's Lymphoma

A Study Comparing Maintenance Subcutaneous Rituximab With Observation Only in Participants With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma Who Had Responded to Rituximab-based Immunochemotherapy Induction and 2-year Maintenance With Subcutaneous Rituximab

MabCute
Start date: December 20, 2011
Phase: Phase 3
Study type: Interventional

This multicenter, randomized, open-label, parallel-group study will evaluate the efficacy and safety of subcutaneously administered rituximab in comparison with observation only as maintenance therapy in participants with relapsed or refractory indolent Non-Hodgkin's lymphoma (NHL). All participants will receive induction therapy with rituximab (375 milligrams per square meter [mg/m^2] intravenously [IV] in Cycle 1, then 1400 mg subcutaneous [SC] every 3-4 weeks) plus standard chemotherapy for 6-8 months; followed by 24 months of maintenance I period with rituximab (1400 mg SC every 8 weeks). Participants completing therapy and showing partial or complete response will be randomized to receive either rituximab (1400 mg SC every 8 weeks) or observation with no treatment during maintenance II period and will be followed for at least 15 months. Anticipated time on study treatment is until disease progression, unacceptable toxicity or end of study, whichever occurs first.

NCT ID: NCT01346709 Completed - Clinical trials for Complication of Surgical Procedure

Prospective Evaluation of a RIsk Score for Postoperative Pulmonary COmPlications in Europe

PERISCOPE
Start date: May 2011
Phase:
Study type: Observational

Prospective Evaluation of a RIsk Score for postoperative pulmonary COmPlications in Europe (PERISCOPE) is a multi-centre, international observational study of a random-sample cohort of patients undergoing a nonobstetric in-hospital surgical procedure under general or regional anaesthesia during a continued 7-day period of recruitment.

NCT ID: NCT01344889 Completed - Clinical trials for Hepatitis C, Chronic

An Observational Study on The Prediction of Adverse Events in Patients With Chronic Hepatitis C Receiving a Long-Acting Interferon Plus Ribavirin (GUARD-C)

Start date: October 2009
Phase: N/A
Study type: Observational

This observational study will assess factors leading to dose reductions/treatment discontinuations and the effect on sustained virological response in patients with chronic hepatitis C receiving a long-acting interferon (e.g. Pegasys/peginterferon alfa-2a) and ribavirin. Data will be collected from each patient for the duration of their treatment and for up to 6 months thereafter.

NCT ID: NCT01309295 Completed - Clinical trials for Anemia, Kidney Disease, Chronic

An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Patients With Chronic Kidney Disease in Pre-Dialysis or Dialysis

Start date: November 2010
Phase: N/A
Study type: Observational

This prospective observational study will assess the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in clinical practice in patients with chronic kidney disease, in pre-dialysis or on dialysis, initiated on Mircera treatment. Data from each patient will be collected over 12 months of treatment.

NCT ID: NCT01307397 Completed - Malignant Melanoma Clinical Trials

A Study of Vemurafenib in Participants With Metastatic Melanoma

Start date: March 1, 2011
Phase: Phase 3
Study type: Interventional

This multi-center study evaluates the safety and efficacy of vemurafenib in participants with BRAF V600 mutation-positive, surgically incurable, and unresectable Stage IIIC or IV (American Joint Committee on Cancer [AJCC]) metastatic melanoma.