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NCT ID: NCT00590382 Approved for marketing - Defects Clinical Trials

Emergency/Compassionate Use - Muscular VSD Occluder

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

Expanded access to the AMPLATZER Muscular VSD Occluder

NCT ID: NCT00649545 Approved for marketing - Clinical trials for Rheumatoid Arthritis

Study of the Human Anti-TNF Monoclonal Antibody in Patients With Active Rheumatoid Arthritis

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

The primary objective of this study is to assess the safety (by collecting adverse events and serious adverse events) of adalimumab administered every other week to patients with moderately to severly active rheumatoid arthritis who have failed prior disease-modifying anti-rheumatic drugs (DMARDs).

NCT ID: NCT00650026 Approved for marketing - Clinical trials for Rheumatoid Arthritis

Early Access Program of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Rheumatoid Arthritis

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

Multicenter Early Access Program of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Active Rheumatoid Arthritis

NCT ID: NCT00650390 Approved for marketing - Clinical trials for Rheumatoid Arthritis

Open Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody Adalimumab

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

The study was to explore the efficacy of adalimumab in subjects previously treated with infliximab and failed infliximab treatment due to lack of efficacy or intolerance. To explore the safety of adalimumab in subjects previously treated with infliximab.

NCT ID: NCT00683306 Approved for marketing - Clinical trials for Non Small Cell Lung Cancer (NSCLC)

Open Label Extension Study With Gefitinib (IRESSAâ„¢) for Completing Trial Patients Who May Benefit From Further Treatment

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

The purpose of this study is to provide gefitinib treatment to patients who, on completion or closure of other gefitinib clinical studies, were either receiving placebo treatment, or are continuing on the same dose and regimen of gefitinib established in their preceding study, for as long as the patients continue to derive benefit.

NCT ID: NCT00684385 Approved for marketing - Clinical trials for Non Small Cell Lung Cancer

An Expanded Access Programme With Iressa for Patients With Non-Small-Cell Lung Cancer and Cancer of the Head and Neck

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

The purpose of this study is to provide ZD1839 for those patients with locally advanced and/or metastatic non-operable non-small cell lung cancer (stage III or IV) or recurrent and/or metastatic squamous cell head and neck cancer who receive the therapy on an expanded access basis due to their inability to meet eligibility criteria for on-going recruiting trials, inability to participate in other clinical trials (e.g., poor performance status, lack of geographic proximity), or because other medical interventions are not considered appropriate or acceptable.

NCT ID: NCT00686621 Approved for marketing - Mycoses Clinical Trials

Single Patient Treatment of Posaconazole in Invasive Fungal Infections (Study P05113)

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

The purpose of this study is to provide posaconazole compassionate treatment to patients with invasive fungal infections: 1) which are resistant to standard antifungal therapies; 2) for which there are no effective therapies; 3) with a prior history of serious, severe, or life-threatening toxicities while receiving standard antifungal therapies, or 4) with pre-existing organ dysfunction which precludes the use of standard antifungal therapies.

NCT ID: NCT00730444 Approved for marketing - Neuroblastoma Clinical Trials

Expanded Access Protocol for [123I]mIBG for Patients With Known or Suspected Neuroblastoma

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

GE Healthcare has recently submitted a New Drug Application (NDA) for Iobenguane I 123 Injection ([123I]mIBG (AdreView)) as a diagnostic nuclear imaging agent for the detection of primary or metastatic neuroblastoma and pheochromocytoma. The present protocol establishes an Expanded Access program to provide AdreView to pediatric medical centers and hospitals that treat neuroblastoma patients. AdreView will be provided for use in diagnostic assessment of patients with known or suspected neuroblastoma for whom there is an appropriate clinical indication for [123I]mIBG imaging.

NCT ID: NCT00786058 Approved for marketing - Pancreatic Cancer Clinical Trials

A Phase III Second Line Trial in Advanced Pancreatic Cancer CONKO 003

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

The purpose of this study is to compare best supportive care plus oxaliplatin/ folinic acid/ 5-FU versus best supportive alone in patients with gemcitabine refractory pancreatic cancer.

NCT ID: NCT00866164 Approved for marketing - Back Pain Clinical Trials

Prometra's Utilization in Mitigating Pain II

(PUMP 2)
Start date: n/a
Phase: N/A
Study type: Expanded Access

Intrathecal infusion pumps are increasingly used to deliver analgesics for chronic intractable pain. The PUMP II trial is designed to evaluate the ongoing safety and efficacy of the new Prometra® Programmable Pump System for intrathecal administration of morphine sulfate to treat chronic intractable pain.