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NCT ID: NCT01070485 Completed - Breast Cancer Clinical Trials

BAY88-8223, Alpharadin, Breast Cancer Patients With Bone Dominant Disease

Start date: January 2010
Phase: Phase 2
Study type: Interventional

The purpose of the study is to investigate if multiple (up to four) intravenous injections of Xofigo (Alpharadin) have any clinically relevant effect on bone markers in breast cancer patients with bone dominant disease who have progressed on endocrine therapy and are no longer considered suitable for endocrine therapy. In addition the safety of Xofigo (Alpharadin) will be assessed.

NCT ID: NCT01069692 Completed - Clinical trials for Chronic Kidney Disease

Placebo Versus SBR759 in Lowering Phosphate in Dialysis Patients

SBR759
Start date: February 2010
Phase: Phase 3
Study type: Interventional

This study will compare placebo to 4 different doses of SBR759 to assess the phosphate lowering efficacy in dialysis patients.

NCT ID: NCT01067820 Completed - Clinical trials for Coronary Artery Disease

ApoA-I Synthesis Stimulation and Intravascular Ultrasound for Coronary Atheroma Regression Evaluation

ASSURE I
Start date: September 2011
Phase: Phase 2
Study type: Interventional

This study is designed to characterize the early effects of ApoA-I synthesis with RVX000222 on coronary atherosclerotic disease when administered to patients with coronary artery disease and have a low HDL-C level, as assessed by Intravascular Ultrasound (IVUS) in addition to standard background therapy.

NCT ID: NCT01066962 Completed - HIV Infections Clinical Trials

Study of Darunavir/r + Tenofovir/Emtricitabine vs. Darunavir/r + Raltegravir in HIV-infected Antiretroviral naïve Subjects

ANRS 143
Start date: August 2010
Phase: Phase 3
Study type: Interventional

The triple therapy darunavir/r + tenofovir/emtricitabine is likely to become a relevant first-line treatment option in the years to come. The dual combination of boosted darunavir + raltegravir is an innovative treatment option that combines two potent new antiretroviral drugs, one of which belongs to a new drug class (integrase inhibitor). The expected efficacy profile of this combination is promising. Moreover, this combination might have a better tolerance profile and has the advantage of sparing the NRTI class. In the context of tenofovir/emtricitabine currently being a reference backbone in first-line antiretroviral regimens, we hypothesise that, in combination with darunavir/r, raltegravir may be an alternative option if its efficacy is non-inferior to tenofovir/emtricitabine.

NCT ID: NCT01066793 Completed - Clinical trials for Hepatitis C, Chronic

PROPHESYS 2: An Observational Study on Predictors of Response in Treatment-naïve Patients With Chronic Hepatitis C Treated With Pegasys (Peginterferon Alfa-2a) or Peginterferon-alfa-2b

Start date: October 2007
Phase: N/A
Study type: Observational

This observational study will assess predictors of early on-treatment and sustained virological response in treatment-naïve patients with chronic hepatitis C initiated on treatment with Pegasys (peginterferon alfa-2a) or peginterferon alfa-2b and ribavirin. Data will be collected during the treatment period (24 or 48 weeks) and 12 and 24 weeks after the end of treatment. Target sample size is <2000.

NCT ID: NCT01066390 Completed - Melanoma Clinical Trials

A Study on the Safety and Immunogenicity of Combined Intradermal and Intravenous Administration of an Autologous mRNA Electroporated Dendritic Cell Vaccine in Patients With Previously Treated Unresectable Stage III or IV Melanoma

Start date: December 2009
Phase: Phase 1
Study type: Interventional

This phase I study plan is divided in the following four phases: - Eligibility Screen Phase (week -4 to -1): Following written informed consent patients with metastatic melanoma (AJCC stage III/IV with unresectable disease) will undergo an eligibility screen (incl. blood analysis and PET/CT-scan). - TriMix-DC Vaccine Manufacturing Phase (week I to IV): eligible patients will undergo a leucapheresis (15 liter of venous blood) for the preparation of autologous TriMix-DC vaccine. Vaccine preparations will be manufactured and quality-controlled (during an interval of 4 weeks following the leucapheresis) and released for patient administration if the TriMix-DC preparation fulfills the predefined quality requirements. - TriMix-DC Vaccine Administration Phase (Week 1 to 24): 4 weeks after the leucapheresis patients will initiate therapeutic vaccination with the TriMix-DC vaccine by IV and ID administration. The vaccines will be administered at 4 different visits that will be separated with an interval of 2 weeks. At each vaccination a total of 12.106 DC per antigen will be administered. - Patients will be allocated to three different cohorts: - The first cohort will receive 10% of TriMix-DC by iv and 90% by id injection. - The second cohort 25% by iv and 75% by id injection. - The third cohort 50% by iv and 50% by id injection. - During the week following the administration of the fourth vaccine (= week 8), a DTH-test and punch biopsy of the injection site will be performed as well as a second leucapheresis (for the purpose of immuno-monitoring) and tumor evaluation (by PET-CT). - A fifth vaccine will be administered and a repeat tumor staging performed in week 16 (= 8w after the fourth vaccine). - End of study visit: Patients will perform an "end of study visit" 8 weeks after the fifth vaccine (= week 24) as well as a new tumor evaluation (PET/CT). - Follow-up Phase: survival data will be obtained until 3 years after the initiation of vaccine therapy or the time of death.

NCT ID: NCT01065532 Completed - Restenosis Clinical Trials

SEDUCE OCT Study in Coronary Artery rEstenosis:an Optical Coherence Tomography (OCT) Study

SEDUCE
Start date: May 2009
Phase: N/A
Study type: Interventional

Different healing responses after treatment of bare metal stent restenosis with implantation of an everolimus-eluting Xience V stent (Abbott Vascular) versus use of a paclitaxel-eluting SeQuent Please balloon (BBraun): an optical coherence tomography study. A prospective, single-centre, randomized clinical trial with clinical, angiographic and OCT follow-up at 9 months.

NCT ID: NCT01065519 Completed - Clinical trials for Coronary Artery Disease

STACCATO: Stent sTrut Apposition and Coverage in Coronary ArTeries: an Optical Coherence Tomography (OCT) Study

STACCATO
Start date: June 2009
Phase: N/A
Study type: Interventional

Assessment of vessel healing after DES implantation in STEMI, NSTEMI and stable/unstable angina patients: a randomized comparison between everolimus and biolimus A9-eluting stents: an optical coherence tomography (OCT) and intravascular ultrasound-tissue characterisation (IVUS-TC) study. Plaque characterisation substudy: Assessment of culprit lesions in different subsets of patients (STEMI, NSTEMI and stable/unstable angina) by use of optical coherence tomography (OCT) and intravascular ultrasound tissue characterisation (IVUS-TC).

NCT ID: NCT01064817 Completed - Glaucoma Clinical Trials

PRM-151 in the Prevention of Scarring Following Trabeculectomy

Start date: June 14, 2010
Phase: Phase 2
Study type: Interventional

This study will assess the safety and tolerability of PRM-151 administered as a subconjunctival injection and explore the effect of PRM-151 on various correlates of the wound healing process that occurs in the eye after glaucoma filtration surgery.

NCT ID: NCT01064804 Completed - Asthma Clinical Trials

To Test The Relative Bioavailability Of PF-04191834 When Dosed As An Immediate Release Tablet Compared With Solution Following Single And Multiple Dosing

Start date: September 2009
Phase: Phase 1
Study type: Observational

To test the relative bioavailability of PF-04191834 when dosed as an Immediate Release tablet compared with solution following single and multiple dosing.