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Screening for LID Clinical Studies Unit Healthy Volunteer Protocols
https://clinicaltrials.gov/ct2/show/NCT01386424

May 7th, 2020 - The high morbidity and mortality associated with both pandemic and seasonal influenza and the anticipation for future influenza pandemics puts influenza front and center in infectious disease research. Because the natural history and pathogenesis of human influenza has not been well characterized and cannot be adequately studied in animal models or with current in vitro techniques, important qu...

Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) After Failure of Ri...
https://clinicaltrials.gov/ct2/show/NCT03394365

May 3rd, 2020 - This is a multicenter, open-label, phase 3 study to assess the efficacy and safety of tabelecleucel for the treatment of EBV+ PTLD in the setting of SOT after failure of rituximab and rituximab plus chemotherapy (SOT cohort) or HCT after failure of rituximab (HCT cohort). Enrollment will be preceded by confirmation of availability of partially human leukocyte antigen (HLA) matched and restricte...

Tabelecleucel for Allogeneic Hematopoietic Cell Transplant Subjects With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) After Failure of Rituximab
https://clinicaltrials.gov/ct2/show/NCT03392142

May 3rd, 2020 - This is a multicenter, open label, single-arm, phase 3 study to assess the efficacy and safety of tabelecleucel for the treatment of EBV+ PTLD in the setting of allogeneic HCT after failure of rituximab. Tabelecleucel will be selected for the subject from the bank of available tabelecleucel cell products based on matching >= 2 human leukocyte antigen (HLA) alleles, at least one of which is a re...

Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), o...
https://clinicaltrials.gov/ct2/show/NCT03268954

Apr 30th, 2020 - 29-Apr-20 Enrollment of new patients into this study has been paused due to the COVID-19 situation. The duration of this pause is dependent on the leveling and control of the COVID-19 pandemic. The drug being tested in this study is called pevonedistat. Pevonedistat is being tested to treat people with higher-risk myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) and low-b...

A Study to Investigate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of TAK-573 in Participants With Refractory Multiple Myeloma (MM)
https://clinicaltrials.gov/ct2/show/NCT03215030

Apr 30th, 2020 - 29-Apr-2020 Enrollment of new patients into this study has been paused due to the COVID-19 situation. The duration of this pause is dependent on the leveling and control of the COVID-19 pandemic. The drug being tested in this study is called TAK-573 as single agent and in combination with dexamethasone. The study will determine the safety and tolerability of TAK-573 as single agent and in combi...

Acthar Gel in Participants With Pulmonary Sarcoidosis
https://clinicaltrials.gov/ct2/show/NCT03320070

Apr 30th, 2020 - 07-Apr-2020: This trial is continuing for enrolled participants. Recruiting for new participants has stopped at all sites because of COVID-19. Overall Recruitment Status is "Active, Not Recruiting". The Actual Number of Participants is still "Anticipated". When it is safe, Overall Recruiting Status will change back to "Recruiting". When that happens, look at Locations to see which sites have st...

Safety/Efficacy Study of Seqirus A/H7N9 IIV With or Without MF59(R) Adjuvant to Prevent Avian Influenza
https://clinicaltrials.gov/ct2/show/NCT03682120

Apr 30th, 2020 - This is a randomized, double-blinded, Phase II study in healthy males and non-pregnant females, 18-64 years of age. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of a pre-pandemic 2017 monovalent inactivated influenza A/H7N9 virus vaccine (2017 H7N9 IIV) manufactured by Seqirus Inc (Seqirus) administered at different dosages (3.75 mcg, 7.5 mcg and 15 m...

A Study to Evaluate the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of TAK-079 in Combination With Standard Background Therapy in Participants With Moderate to Severe Systemic Lupus Er...
https://clinicaltrials.gov/ct2/show/NCT03724916

Apr 30th, 2020 - 29-Apr-2020 Enrollment of new patients into this study has been paused due to the COVID-19 situation. The duration of this pause is dependent on the leveling and control of the COVID-19 pandemic. TAK-079 is being tested in a study population with moderate to severe SLE. This study will evaluate the safety and biologic activity of TAK-079 or matching placebo in combination with stable SLE backgr...

Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzh...
https://clinicaltrials.gov/ct2/show/NCT03393520

Apr 28th, 2020 - Eligible participants for this study must have a diagnosis of probable Alzheimer's disease (AD) and must have clinically significant, moderate/severe agitation secondary to AD. This is a multicenter, randomized, double-blind, placebo-controlled, parallel-design study, consisting of 12 weeks of treatment. Approximately 412 participants will be enrolled at approximately 90 centers worldwide. Stud...

Long Term, Extension Study of the Safety and Efficacy of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
https://clinicaltrials.gov/ct2/show/NCT02446132

Apr 28th, 2020 - Participant has successfully completed Studies 15-AVP-786-301, 15-AVP-786-302, 12-AVR-131, or 17-AVP-786-305. Participants will be enrolled in the study for approximately 56 weeks (participants who have a follow-up visit 3 months after the last dose of treatment will be enrolled for approximately 64 weeks). Approximately 1000 participants will be enrolled at approximately 250 centers globally. ...

Hunter Outcome Survey (HOS)
https://clinicaltrials.gov/ct2/show/NCT03292887

Apr 27th, 2020 - 24 APRIL 2020: Enrollment of new patients into this study has been paused due to the COVID-19 situation. The duration of this pause is dependent on the leveling and control of the COVID-19 pandemic.

Gaucher Disease Outcome Survey (GOS)
https://clinicaltrials.gov/ct2/show/NCT03291223

Apr 27th, 2020 - 24 APRIL 2020: Enrollment of new patients into this study has been paused due to the COVID-19 situation. The duration of this pause is dependent on the leveling and control of the COVID-19 pandemic.

Fabry Outcome Survey (FOS)
https://clinicaltrials.gov/ct2/show/NCT03289065

Apr 27th, 2020 - 24 APRIL 2020: Enrollment of new patients into this study has been paused due to the COVID-19 situation. The duration of this pause is dependent on the leveling and control of the COVID-19 pandemic.

Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis
https://clinicaltrials.gov/ct2/show/NCT03259308

Apr 27th, 2020 - 27Mar2020: Enrollment of new patients into this study has been paused due to the COVID-19 situation. The duration of this pause is dependent on the leveling and control of the COVID-19 pandemic.

Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis
https://clinicaltrials.gov/ct2/show/NCT03259334

Apr 27th, 2020 - 27Mar2020: Enrollment of new patients into this study has been paused due to the COVID-19 situation. The duration of this pause is dependent on the leveling and control of the COVID-19 pandemic.

Real-world CANadian CUvitru Non-Interventional Study in Subjects Transitioning From Subcutaneous Immunoglobulin (CANCUN)
https://clinicaltrials.gov/ct2/show/NCT03716700

Apr 27th, 2020 - 24-APR-2020: Enrollment of new patients into this study has been paused due to the COVID-19 situation. The duration of this pause is dependent on the leveling and control of the COVID-19 pandemic.

Transfusion Trigger After Operations in High Cardiac Risk Patients
https://clinicaltrials.gov/ct2/show/NCT03229941

Apr 26th, 2020 - As a consequence of COVID 19 and after consultation with research oversight, regulatory and monitoring entities enrollment has been placed on a temporary hold. Background: Despite the need for clinically appropriate use of blood products in the postoperative setting, blood transfusion practices are empiric and variable. In the absence of a physiologic test that can effectively guide transfusion...

Safety and Dose Escalation Study of an Adeno-Associated Viral Vector for Gene Transfer in Hemophilia A Participants
https://clinicaltrials.gov/ct2/show/NCT03370172

Apr 26th, 2020 - This study consists of 3 cohorts. Participants will be assigned to 1 of 2 dose cohorts with a minimum of 24 hours between dosing of each participant. Initially, 2 participants will be dosed in a cohort, with up to a total of 5 participants if the cohort is expanded based on safety and FVIII expression data. Dose escalation: After dosing first 2 participants in cohort 1 or cohort 2 on day 0 if w...

Phase III Efficacy, Safety, and Tolerability Study of HYQVIA/HyQvia and GAMMAGARD LIQUID/KIOVIG in CIDP
https://clinicaltrials.gov/ct2/show/NCT02549170

Apr 26th, 2020 - 23 APRIL 2020: Enrollment of new patients into this study has been paused due to the COVID-19 situation. The duration of this pause is dependent on the leveling and control of the COVID-19 pandemic.