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NCT ID: NCT01031173 No longer available - Fabry Disease Clinical Trials

Treatment Protocol of Replagal for Patients With Fabry Disease

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

The study will evaluate the safety and efficacy of Replagal® (agalsidase alfa) at a dose of 0.2 mg/kg infused intravenously (IV) over 40 minutes, every other week. The study will monitor the course of disease in males and females with Fabry disease who are naive to treatment or were previously treated with agalsidase beta (Fabrazyme®).

NCT ID: NCT01000012 No longer available - Clinical trials for Breast Reconstruction

Compassionate Use of the Becker Expander/Breast Implant

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

To provide access of the Becker Expander/Breast implant to women who do not meet inclusion/exclusion criteria of the Becker Continued Access Study Patients' physician will contact Mentor to request use of the device and each request will be reviewed by Mentor, an IRB, and the FDA on a case-by-case basis

NCT ID: NCT00999414 No longer available - Multiple Myeloma Clinical Trials

UARK 2009-32 Compassionate Use Study of Carfilzomib

2009-32
Start date: November 2009
Phase: N/A
Study type: Expanded Access

This is a compassionate use, open-label, IND study for the purpose of providing carfilzomib to patients with relapsed or resistant refractory multiple myeloma.

NCT ID: NCT00975546 No longer available - HIV Infections Clinical Trials

HIV-discordant Couple Intrauterine Insemination

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

The investigators propose to treat couples who wish to have a child in which the man is HIV-positive and the woman is HIV-negative. The investigators call these couples HIV-discordant. On the average, an HIV-positive man, who does not participate in high-risk activities, will transmit HIV to a female partner one in every one thousand acts of intercourse without a condom. To reduce transmission of HIV, HIV-discordant couples are counseled to avoid intercourse altogether, or to use condoms during every act of intercourse. In order to have a child, these patients can use donor insemination. If they wish to have a natural child of the infected man, they can use a combination of medication of the man to reduce the amount of virus in his semen, and condom use except at the time of ovulation when the woman produces an egg. This reduces the chance of infecting the woman, but studies have shown that about 4% of women will be infected with HIV using this approach. Alternatively, they can use vitro fertilization (IVF) with intra cytoplasmic sperm injection (ICSI) in which eggs are collected from the woman after hormone-stimulation and are fertilized in the laboratory by injecting a single washed sperm from her husband into each egg. The resulting embryos can be transferred to the wife's uterus and/or frozen for later use. These procedures are believed to minimize the risk of HIV transmission (although the number of cases is low), but IVF-ICSI is very expensive and are not an option for everyone. A simpler method used for over 15 years in Europe is to collect the man's semen, wash the sperm in the laboratory, and test the sperm sample for HIV before placing it in the woman's uterus (intrauterine insemination; IUI). Although the risk of HIV transmission to the woman is presumably not zero with this method, over 4000 inseminations reported have not resulted in infection of any female patients or resulting children.

NCT ID: NCT00962260 No longer available - Gaucher Disease Clinical Trials

Expanded Access Trial of Plant Expressed Recombinant Glucocerebrosidase (prGCD) in Patients With Gaucher Disease

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

This is an open-label expanded access trial of prGCD in patients with Gaucher disease who require enzyme replacement therapy (ERT) and who have been treated with imiglucerase but for whom the dose has been reduced or discontinued due to shortage of the product.

NCT ID: NCT00931086 No longer available - Clinical trials for Rheumatoid Arthritis

Expanded Access Trial of Belimumab Antibody in RA Patients Who Were Previously Treated Under HGS Protocol LBRA99

LBRA99
Start date: April 2009
Phase: Phase 4
Study type: Expanded Access

An expanded access trial of belimumab for named patients who participated in LBRA99.

NCT ID: NCT00870636 No longer available - Clinical trials for Retinopathy of Prematurity

Use of Pan-vascular Endothelial Growth Factor Receptor (Pan-VEGF) Blockade for the Treatment of Retinopathy of Prematurity (ROP) (Compassionate Use BLOCK-ROP)

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

The purpose of this study is to provide access to intravitreal injection of Avastin in high-risk infants who do not otherwise qualify for study NCT00702819, an investigational multi-site study examining Avastin use for retinopathy of prematurity.

NCT ID: NCT00862758 No longer available - Clinical trials for Juvenile Idiopathic Arthritis

Request for Single Patient IND for Compassionate/Emergency Use of Tocilizumab

Start date: February 2009
Phase: N/A
Study type: Expanded Access

Application for Compassionate Use of Tocilizumab in a Boy with Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) Unresponsive to All Licensed Medications.

NCT ID: NCT00852345 No longer available - Leprosy Clinical Trials

Treatment Protocol for Clofazamine in the Long Term Treatment of Leprosy

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

Clofazimine has shown effectiveness in the treatment of leprosy for many years. The World Health Organization and the National Hansen's Disease Program consider clofazamine to be standard therapy for treatment of multibacillary leprosy. In recent years, the availability of the drug has become limited and is currently available only under a research protocol and is considered "investigational." Use of Clofazamine in patients presenting with lepromatous leprosy is necessary for patients exhibiting nerve involvement or lesions resistant to other therapies. This drug will be used prospectively for patients who require treatment of leprosy as deemed appropriate by a Kaiser Permanente Southern California physician.

NCT ID: NCT00841451 No longer available - Atrial Fibrillation Clinical Trials

Pulmonary Vein Isolation Outcomes With Fish Oils

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

Fish oil therapy may decrease the incidence of cardiac arrhythmias. This study will test whether pre-treatment with fish oils before catheter ablation of atrial fibrillation decreases the early post operative occurrence of atrial fibrillation.