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NCT ID: NCT01476163 Approved for marketing - Fabry Disease Clinical Trials

Physician Initiated Expanded Access Request for Migalastat in Individual Patients With Fabry Disease

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

This program allows physicians to request permission from Amicus Therapeutics (Amicus) for treatment access to migalastat hydrochloride (HCl) for specific adult patients with Fabry disease. Treatment is open label for 6 months with renewal every 6 months.

NCT ID: NCT01480128 Approved for marketing - Colon Neoplasms Clinical Trials

Multicenter Single-port Colectomy RCT

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

This clinical trial is going to compare the single-port and multi-port laparoscopic colectomy for colon cancer treatment, in terms of safety, efficacy, and cost. The investigators hypothesize that the single-port laparoscopic colectomy is not inferior to multiport laparoscopic colectomy.

NCT ID: NCT01579890 Approved for marketing - Clinical trials for Osteoarthritis of the Hand

Compassionate Use of Pennsaid Topical Lotion (Diclofenac) in Osteo or Rheumatoid Arthritis

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

This was a compassionate use, open treatment safety study of Pennsaid topical lotion (diclofenac) for osteo or rheumatoid arthritis.

NCT ID: NCT01592136 Approved for marketing - Clinical trials for Chronic Myeloid Leukemia (CML)

Expanded Access Program of Ponatinib

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

This protocol will allow expanded access of ponatinib to patients ≥18 years with chronic myeloid leukemia (CML) any phase or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL) who have failed all available treatment options.

NCT ID: NCT01606982 Approved for marketing - Clinical trials for Metastatic Castration-Resistant Prostate Cancer

Provide Expanded Access to MDV3100 and Monitor Its Safety in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy

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

The purpose of this treatment protocol is to provide expanded access to MDV3100 and monitor its safety in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy.

NCT ID: NCT01632826 Approved for marketing - Multiple Myeloma Clinical Trials

Pomalidomide (POM) in Combination With Low Dose Dexamethasone (LD-Dex) in Patients With Relapsed or Refractory Multiple Myeloma

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

To provide pomalidomide access to relapsed/refractory multiple myeloma subjects with a likelihood of benefit from the pomalidomide treatment while the medication is not commercially available

NCT ID: NCT01683110 Approved for marketing - Clinical trials for Medullary Thyroid Cancer

Expanded Access of Cabozantinib in Medullary Thyroid Cancer

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

The objective of this study is to provide access to cabozantinib for eligible subjects with medullary thyroid cancer (MTC) pending approval of Exelixis' New Drug Application (NDA) by the FDA and commercial availability of cabozantinib.

NCT ID: NCT01764191 Approved for marketing - Cardiac Sarcoidosis Clinical Trials

18F-FDG PET Imaging in Cardiac Sarcoidosis

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

This study has been designed to provide patients suspected of having cardiac sarcoidosis (CS) with a potentially diagnostic 18F FDG PET/CT. CS is difficult to diagnose with currently available methods, therefore this project will allow access to 18F FDG PET/CT scanning, which may more accurately diagnose the presence of CS. This study will also provide additional data to further examine the effectiveness and safety profile of 18F FDG for this condition. Accurate and early detection is important to allow for better management of CS and improve patient care. The purpose of this study is to provide access to 18F-FDG PET/CT imaging in patients with clinical suspicion of cardiac sarcoidosis, and to collect additional data about the safety and effectiveness of 18F-FDG PET/CT in this patient population

NCT ID: NCT01779518 Approved for marketing - Clinical trials for Post-transplant Hepatitis C

Expanded Access Program of Sofosbuvir With Ribavirin and With or Without Pegylated Interferon in Aggressive Post-transplant Hepatitis C

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

This is a single arm, open-label study which will be opened at specific clinical sites at the request of an investigator for the treatment of individual subjects for whom there are no other treatment options. Subjects will be treated for 24 weeks with sofosbuvir (400mg QD) with RBV; pegylated interferon may be added at the discretion of the investigator.

NCT ID: NCT01825395 Approved for marketing - Clinical trials for Lambert Eaton Myasthenic Syndrome

Use of 3,4-Diaminopyridine in the Treatment of Lambert-Eaton Syndrome

3 4-DAP
Start date: n/a
Phase:
Study type: Expanded Access

To learn more about the effect of 3, 4-Diaminopyridine (3,4-DAP) on patient diagnosed with Lambert-Eaton myasthenic syndrome (LEMS).