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NCT ID: NCT00245739 Approved for marketing - HIV Infections Clinical Trials

TMC114-C226: An Early Access Program to Evaluate the Long-term Safety and Tolerability of TMC114 Combined With a Low Dose of Ritonavir (TMC114/r) With Other Antiretrovirals, for HIV-1 Infected Patients Who Have Failed Multiple Antiretroviral Regimens.

Start date: n/a
Phase: Phase 3
Study type: Expanded Access

The purpose of this study is to provide early access to TMC114 (a protease inhibitor) for HIV-1 infected patients with limited or no treatment options, who have failed multiple antiretroviral (ARV) regimens, and to evaluate the longer-term safety and tolerability of TMC114/r in combination with other antiretrovirals

NCT ID: NCT00377065 Approved for marketing - HIV Infections Clinical Trials

Early Access of MK0518 in Combination With an Optimized Background Antiretroviral Therapy (0518-023)

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

This is a treatment use study to provide early access to MK0518 for the treatment of HIV-1 infection in patients who have limited or no treatment options due to virological failure, resistance, or intolerance to multiple antiretroviral regimens. Enrollment in this study is patient driven. Investigators are not proactively assigned. There is no target sample size and duration of the study is indefinite. For information on how to enroll in the study, see link below.

NCT ID: NCT00438789 Approved for marketing - Clinical trials for Hemoglobinuria, Paroxysmal

The Paroxysmal Nocturnal Hemoglobinuria Early Access Treatment Protocol

EMBRACE
Start date: n/a
Phase: Phase 3
Study type: Expanded Access

The primary objective is to provide access to eculizumab for PNH patient pending commercial availability.

NCT ID: NCT00481559 Approved for marketing - Neoplasms Clinical Trials

Treatment Protocol of Voraxaze for Patients Experiencing or at Risk of Methotrexate Toxicity

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

This protocol is for the treatment of toxic plasma methotrexate concentrations (>1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function

NCT ID: NCT00484991 Approved for marketing - Phenylketonuria Clinical Trials

Sapropterin Expanded Access Program

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

The Purpose of this study is to provide patients with hyperphenylalaninemia (HPA) due to Phenylketonuria (PKU) access to sapropterin dihydrochloride and to collect more information about the safety of the drug in an expanded access program (EAP) until commercial product is available.

NCT ID: NCT00499720 Approved for marketing - Cystic Fibrosis Clinical Trials

Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection

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

The primary objective of this program is to provide expanded access to aztreonam lysine for inhalation (AZLI) 75 mg prior to its commercial availability to patients with cystic fibrosis (CF) and chronic P. aeruginosa airway infection who have limited treatment options and are at risk for disease progression.

NCT ID: NCT00520143 Approved for marketing - Clinical trials for Pompe Disease (Late-Onset)

Alglucosidase Alfa Temporary Access Program

ATAP
Start date: n/a
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 expanded access study is to provide patients with Pompe disease in the United States (US), access to alglucosidase alfa produced from a scaled up manufacturing process for a limited time until production at this scale is approved for commercial use by the Food and Drug Administration.

NCT ID: NCT00528320 Approved for marketing - Clinical trials for Congestive Heart Failure (CHF)

Clinical Evaluation of Cardiac Resynchronization Therapy (CRT) Using the Ovatio CRT Implantable Cardioverter-defibrillator (ICD) System

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

This study provides a continued access registry for cardiac resynchronization therapy with defibrillation (CRT-D), which helps to resynchronize (coordinate) the rhythm of the heart by helping the left ventricle contract (pump blood) more uniformly, in patients with severe heart failure (New York Heart Association [NYHA] Class III or IV). Quality of life, adverse events and device success will be analyzed and reported.

NCT ID: NCT00580658 Approved for marketing - Dystonia Clinical Trials

Humanitarian Device Exemption

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

The purpose of this study is to allow patients to undergo deep brain stimulation (DBS) surgery for the treatment of dystonia. This is NOT a research study, but rather, a requirement by the FDA for humanitarian use of the deep brain stimulator device in the treatment of this rare disorder. Use of DBS for dystonia is approved for humanitarian use by the FDA in the treatment of chronic, intractable (drug refractory) dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis) in patients 7 years or older. Thus, this proposal request authorization by the IRB to allow patients at VUMC to access this HUD therapy.

NCT ID: NCT00584064 Approved for marketing - Clinical trials for Patent Foramen Ovale

Emergency/Compassionate Use PFO Occluder

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

Emergency/compassionate use for the AMPLATZER PFO Occluder