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NCT ID: NCT05733650 Approved for marketing - Clinical trials for Large B-cell Lymphoma

Expanded Access Program for Epcoritamab

Start date: n/a
Phase:
Study type: Expanded Access

The purpose of this program is to provide investigational epcoritamab, an antibody also known as GEN3013 (DuoBody-CD3xCD20), in an expanded access setting for eligible patients with relapsed and/or refractory (R/R) large B-cell lymphoma (LBCL) who have a high unmet medical need with no other treatment options. It is a requirement that patients do not qualify for an ongoing epcoritamab clinical program or are unable to participate due to logistical reasons. Access to investigational epcoritamab can be requested by contacting preapprovalaccessprograms@genmab.com.

NCT ID: NCT05757973 Approved for marketing - Clinical trials for Relapsed or Refractory Multiple Myeloma

Pre-Approval Access Program for Talquetamab in Relapsed or Refractory Multiple Myeloma

Start date: n/a
Phase:
Study type: Expanded Access

The purpose of this pre-approval access program is to give talquetamab monotherapy (treatment with single drug) to participants with relapsed or refractory multiple myeloma (a type of cancer that begins in plasma cells [white blood cells that produce antibodies] which has returned or difficult to treat) who have relapsed on or are refractory to all locally available and clinically appropriate treatment and who are not eligible for a clinical trial.

NCT ID: NCT02686541 Approved for marketing - Clinical trials for Peripheral Arterial Disease

Athrectomy and Drug Eluting Balloon Therapy (ADEBT) on the Femoral Popliteal Arteries

ADEBT
Start date: April 2015
Phase: N/A
Study type: Expanded Access

The aim of this study is to study the effects of athrectomy followed by percutaneous transluminal angioplasty using Paclitaxel coated Drug Eluting Balloon (DEB) in treating de novo or re-stenotic lesions in the femoral-popliteal artery in patients with symptomatic peripheral vascular disease in an Asian population. The intention is to study the effects of debulking athrectomy followed by application of DEBs to prevent restenosis, resulting in improved patency rates The study will prospectively recruit 8 cases treated with athrectomy followed by DEB. This project is a pilot to investigate the effects of athrectomy and DEB in reducing re-stenosis rates. It will be a primer for a larger scale randomized controlled trial (RCT) involving multiple institutions to demonstrate the benefit of athrectomy and DEB technology to treat de novo versus plain balloon angioplasty with bail-out stenting, which is currently the most commonly used modality to treat femoral-popliteal lesions. There are no studies combining the effect of rotational athrectomy and DEBs.

NCT ID: NCT00811525 Approved for marketing - Clinical trials for Breast Reconstruction

Post Approval Continued Access Study of the MENTOR® Contour Profile Gel Breast Implant

CPG-CA
Start date: August 2004
Phase: N/A
Study type: Expanded Access

The Contour Profile Gel Continued Access Study is designed to demonstrate safety of Mentor's Mammary Prostheses in women who are undergoing primary augmentation, primary reconstruction, or revision. Safety information on the rate of capsular contracture, rupture, and infection will be collected, and used to help determine device safety. With approval of MemoryShape™ Medium Height, Moderate Profile (CPG 321) Breast Implants on June 14, 2013, CPG CA Study subject enrollment has closed and the study has converted to a post approval study for this style.

NCT ID: NCT01868893 Approved for marketing - Clinical trials for Chronic Lymphocytic Leukemia

An Expanded Access, Open-Label Study of Obinutuzumab (GA101) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia

Start date: August 2013
Phase: Phase 4
Study type: Expanded Access

This is a multicenter, open-label, single-arm, expanded access treatment study designed to provide obinutuzumab to patients with previously untreated CLL in combination with chlorambucil and to evaluate the safety and efficacy of obinutuzumab administered in combination with chlorambucil. This study will enroll patients with previously untreated CD20-positive CLL requiring treatment according to the IWCLL guidelines (Hallek et al 2008), as assessed by the investigator.

NCT ID: NCT01917396 Approved for marketing - Clinical trials for Postoperative Bowel Sounds

Influence of Preoperative Enema Application on Return of Gastrointestinal Function After Elective Cesarean Section: A Randomized Controlled Study

Start date: August 2013
Phase: Phase 4
Study type: Expanded Access

The researchers investigate that use of preoperative enema to the effect postoperative bowel gas passage.

NCT ID: NCT00074919 Approved for marketing - Clinical trials for Glycogen Storage Disease Type II

Expanded Access Use of Myozyme (Alglucosidase Alfa) in Patients With Infantile-onset Pompe Disease

Start date: December 2003
Phase: N/A
Study type: Expanded Access

Pompe disease (also known as glycogen storage disease Type II) is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function. The objective of this protocol is to provide enzyme replacement therapy with rhGAA on an expanded access basis, to severely affected patients with infantile-onset Pompe disease for whom there is no alternative treatment and who do not meet the clinical characteristics described in the inclusion criteria for participation in other Genzyme Corporation-sponsored study currently enrolling patients with infantile-onset Pompe disease.

NCT ID: NCT00097799 Approved for marketing - HIV Infections Clinical Trials

Tipranavir Expanded Access Program (EAP) in PI-experienced Patients With HIV-1 Infection

Start date: December 2004
Phase: N/A
Study type: Expanded Access

This study was designed to provide early access to and evaluate the safety of TPV/r in PI-experienced patients with HIV-1 infection.

NCT ID: NCT00338442 Approved for marketing - Varicella Clinical Trials

Safety and Efficacy of Varicella Zoster Immune Globulin (Human) VariZIG in Patients at Risk of Varicella Infection

Start date: February 2006
Phase: N/A
Study type: Expanded Access

This study is to assess VariZIG™ for the treatment of patients at risk for developing serious complications from chicken pox.

NCT ID: NCT02181868 Approved for marketing - Mandible Fracture Clinical Trials

Comparison of Biodegradable and Titanium Fixation Systems in Mandibular Symphysis or Parasymphysis Solitary Fractures

Start date: January 2008
Phase: N/A
Study type: Expanded Access

The mandible bears a wide range of mechanical load from the contraction of masticatory muscles, and has a significant function in normal chewing movements. Mandibular fractures are the most common maxillofacial fractures, accounting for 40%-71% of all maxillofacial fracture cases with an average of 62%. The etiology of mandibular fractures mainly includes assaults, road traffic accidents (RTAs), falls, and sports injuries. Although a wide variance exists in the reported percentage of anterior mandible fractures, aggregate analysis approximates these fractures at 17% of all mandibular fractures. The rigid internal fixation (RIF) technique has become a common treatment for mandibular fractures, in which titanium plates are used in the operation. Some patients have to remove the titanium plates in a second operation following bone healing because of sequelae, such as stress shielding. Biodegradable plates and screws have been developed to eliminate the problems associated with titanium fixtures. In this study, we aim to compare the clinical performance between biodegradable and titanium fixation systems after 12 months of follow-up in fixation of mandibular symphysis and parasymphysis solitary fractures. We also investigate the stress distributions of biodegradable and titanium fixation systems at mandibular symphysis solitary fracture on the conditions of intercuspal position, labial teeth occlusion, and premolar and molar occlusion using finite element analysis.