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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: NCT00878943 No longer available - Clinical trials for Pulmonary Arterial Hypertension

Open Label Access Study Of Sildenafil In Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 Study

UK 92480
Start date: n/a
Phase:
Study type: Expanded Access

In an earlier study, sildenafil citrate administered to patients of PAH led to improvement in pulmonary arterial pressure, cardiac output, quality of life, and other parameters as compared to placebo. This protocol provides mechanism for patients who have clinical deterioration on other PAH approved therapies to have access to sildenafil prior to marketing authorization in India.

NCT ID: NCT00948493 No longer available - Clinical trials for Type 2 Diabetes Mellitus

Treatment Use of Generex Oral-lyn™ in Patients With Diabetes

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

The objective of this Treatment IND protocol is to provide Generex Oral-lyn™ to patients with serious or life-threatening Type 1 or Type 2 diabetes mellitus, with no satisfactory alternative therapy available for treatment of diabetes, and who are not eligible to participate in the ongoing pivotal clinical trial (Protocol GEN-084-OL). This protocol is intended as a substitute for the Single Patient IND mechanism to obtain Generex Oral-lyn™.

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: 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: NCT00992654 No longer available - Clinical trials for Human Immunodeficiency Virus (HIV)

A Treatment Access Program To Provide Maraviroc To Eligible Adult Patients Completing A4001050 Study Until Commercial Availability Of Maraviroc (Celsentri) In India

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

The new protocol will allow the patients enrolled on A4001050 to have continuous access of Maraviroc and the treatment will not be interrupted until the drug is commercially available in India.

NCT ID: NCT00994916 No longer available - Clinical trials for Lambert-Eaton Myasthenic Syndrome

Treatment of Lambert-Eaton Syndrome With 3,4 Diaminopyridine

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

The purpose of the study is to provide expanded access (compassionate use) of 3,4 diaminopyridine to patients with Lambert-Eaton myasthenic syndrome (LEMS).

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: 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: NCT01049633 No longer available - Clinical trials for Type 1 Diabetes Mellitus

B-Lymphocyte Immunotherapy in Islet Transplantation for Initial Islet Graft Failure

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

Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determine the safety and effectiveness of islet transplantation, combined with immunosuppressive medications and medications to support islet survival for treating type 1 diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic episodes.