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Treatment of Targeted Therapy-Related Fatigue in Patients with CML or GIST: A Single-Case Experimental Design

To investigate the efficacy of cognitive behaviour therapy (CBT) on reducing TTF in patients receiving TKIs for CML or GIST.

A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC-41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease

The primary objective of this trial is to evaluate and describe the long-term safety of tolvaptan.

A phase 3 prospective, uncontrolled, multicenter study evaluating pharmacokinetics, efficacy, safety, and immunogenicity of BAX 855 (PEGylated full-length Recombinant FVIII) in previously treated pediatric patients with severe hemophilia A

7.2 Primary ObjectiveThe primary objective is to assess the incidence of FVIII inhibitory antibodies(>=0.6 Bethesda units [BU] using the Nijmegen modification of the Bethesda assay).7.3 Secondary Objectives1. To evaluate the PK parameters of…

A multi-center, uncontrolled extension study evaluating efficacy and safety of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA)

To document the long term safety and efficacy of sarilumab added to DMARDs.

A Phase 3, Multi-Center, Open Label Study of Efficacy and Safety of PEGylated rFVIII (BAX 855) in Previously Treated Patients With Severe Hemophilia A Undergoing Surgical or Other Invasive Procedures

The primary objective is to evaluate the peri-operative hemostatic efficacy of BAX 855 in male PTPs aged 18 - 75 years with severe hemophilia A (FVIII <1%) undergoing major or minor, elective or minor emergency surgical, dental or other…

A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases

Primary: The primary objective of the Double-blind Acute Phase of the study is to assess clinical response to MMX mesalamine/mesalazine between a low and high dose in children and adolescents aged 5-17 years with mild to moderate UC.The primary…

Immune phenotyping in chronic HCV patients treated with Sofosbuvir and Daclatasvir combination for 12 or 24 weeks * SODA study

Primary objectiveThe primary objective for this study is to analyse the impact of inhibition of viral replication by interferon-free therapy consisting of Sofosbuvir and Daclatasvir (±Ribavirin) on the phenotype and function of the innate immune…

A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura.

• The primary objective of this study is to assess the long term safety of fostamatinib in subjects with persistent/chronic ITP.• The secondary objectives of this study are to establish the long-term efficacy of fostamatinib in achieving and…

An open-label canakinumab (ACZ885) dose reduction or dose interval prolongation efficacy and safety study in patients with Systemic Juvenile Idiopathic Arthritis (SJIA)

Primary:To evaluate if the proportion of patients in clinical remission on canakinumab 4mg/kg (+/- concomitant NSAID only) who are able toremain on a reduced canakinumab dose (2mg/kg every 4 weeks) or prolonged canakinumab dose interval (4mg/kg…

A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease

The primary objective of this study is to evaluate the long-term efficacy, safety, and tolerability of repeated administration of adalimumab in subjects with Crohn's disease (CD) who participated in and successfully completed Study M14-115.The…

Study 201312: A Multi-Centre, Open-Label, Study of Mepolizumab in a Subset of Subjects with a History of Life Threatening/Seriously Debilitating Asthma Who Participated in the MEA115661 Trial

Primary: To provide extended treatment with mepolizumab to subjects with severe asthma and a history of improved disease control while receiving mepolizumab as defined by this protocol.Secondary: To collect data on long term clinical data.

Multicenter, open-label extension study to investigate the long-term safety and efficacy of IgPro20 in maintenance treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) in subjects completing study IgPro20_3003.

Primary objective: To evaluate the long-term safety of IgPro20.Secondary objectives: * To evaluate the long-term safety of IgPro20 by dose. * To evaluate the efficacy of IgPro20.Exploratory objectives:* To evaluate health-related quality of life (…

A Multicenter, Long-term Extension Study to Further Evaluate the Safety and Tolerability of Telotristat Etiprate (LX1606)

The primary objective of this study is to evaluate the long-term safety and tolerability of orally administered telotristat etiprate.The secondary objective is to evaluate changes in patients* quality of life (QOL) through week 84.

A Multi-Center,Multi-National Clinical Study to Evaluate the Safety and Effectiveness of the ESSURE (Model ESS505) Device to Prevent Pregnancy in Women Who are Seeking Permanent Contraception

Evaluate the safety and effectiveness of the Essure System for Permanent Birth Control (Model ESS505) in preventing pregnancy

A Long-Term Follow-Up Study of Subjects Who Participated in a Clinical Trial in which
Peginterferon Lambda 1-a (BMS-914143) was Administered for the Treatment of Chronic Hepatitis C

Recent studies demonstrate long-term durability of virologic response with pegylated alpha-interferon-based therapies. Comparable information is not yet available for Lambda or for regimens combining lambda interferons, RBV, and DAAs. In this…

Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial

Primary objective:To evaluate the long-term safety of BI 695500 in adult patients with moderate tosevere active rheumatoid arthritis (RA) who have successfully completed treatment inTrial 1301.1.Secondary objective:* To assess the long-term efficacy…

Multicentre, Open-Label Trial to Assess the Safety and Tolerability of LF111 (Drospirenone 4.0 mg) Over 6 Cycles in Female Adolescents, With a 7-Cycle Extension Phase

It is expected that LF111 will offer benefits to adults in the form of efficacy similar to COCPs, absence of estrogen-related risks, reduced tendency to weight gain and extended dosing window. It is likely that adolescents will share these benefits…

A RAndomized trial comparing COnventional with STereotactic radiotherapy for pain reduction and quality of life in spinal metastases "RACOST"

This study will test the hypothesis that stereotactic radiotherapy gives a better and longer lasting reduction of pain, local control and therewith a better quality of life. This in order to optimize and to individualize the treatment options for…

An open- label, multi-site trial to describe the safety and tolerability of oral cebranopadol administered for 26 weeks in subjects with cancer- related pain who have completed treatment in the KF6005/07 trial.

The primary objective of this trial is to describe the safety and tolerability of prolonged exposure to cebranopadol in subjects suffering from cancer related pain

ABSORB BTK TRIAL
A prospective single arm registry of the Absorb Everolimus-eluting bioresorbable vascular scaffold in below the knee atherosclerotic arterial lesions

The aim of this study is to evaluate the efficacy, and feasibility of the Absorb drug-eluting bioresorbable vascular scaffold in infrapopliteal hemodynamically significant arterial stenoses and occlusions.The primary objective is in-stent restenosis…