Clinical Trials Logo

Filter by:
  • Approved for marketing  
  • Page 1 ·  Next »
NCT ID: NCT00040625 Approved for marketing - Mesothelioma Clinical Trials

ALIMTA (Pemetrexed) Alone or in Combination With Cisplatin for Patients With Malignant Mesothelioma.

Start date: n/a
Phase: Phase 2
Study type: Expanded Access

This study is to evaluate the effects (good and bad) of ALIMTA and Cisplatin or ALIMTA alone on you and your malignant pleural mesothelioma as well as make ALIMTA available to patients who qualify for treatment.

NCT ID: NCT00042393 Approved for marketing - Chronic Hepatitis B Clinical Trials

An Open-Label Program of Adefovir Dipivoxil in the Treatment of Patients With Lamivudine-Resistant Chronic Hepatitis B With Limited Treatment Options

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

The purpose of this early access protocol is to provide access to adefovir dipivoxil prior to its commercial availability to people with lamivudine-resistant chronic hepatitis B who have limited treatment options.

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 - Glycogenosis 2 Clinical Trials

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.