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NCT ID: NCT02437019 Approved for marketing - Clinical trials for B-cell Chronic Lymphocytic Leukemia

Early Access Program (EAP) for Ibrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

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

The purpose of this study is to provide early access to Ibrutinib treatment for participants with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) and collect additional safety data while the medication is not commercially available.

NCT ID: NCT02437500 Approved for marketing - Clinical trials for Clostridioides Difficile Infection

Expanded Access Program of SER-109 in the Treatment of Adults With Recurrent Clostridioides Difficile Infection (RCDI)

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

Subjects will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days. The purpose of this study is to provide access to SER-109 for adult subjects with recurrent Clostridioides Difficile Infection (RCDI) and to monitor subject safety and report to regulatory authorities, as appropriate.

NCT ID: NCT02464943 Approved for marketing - Aortic Dissection Clinical Trials

Zenith® Dissection Endovascular System in the Treatment of Patients With Aortic Dissections

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

The Zenith® Dissection extended study is to collect confirmatory safety and effectiveness data on the Zenith® Dissection Endovascular System in the treatment of acute, complicate Type B aortic dissection.

NCT ID: NCT02471781 Approved for marketing - Aortic Aneurysm Clinical Trials

Zenith® TX2® Low Profile TAA Endovascular Graft

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

The Zenith TX2 Low Profile TAA Endovascular Graft extended study is to collect confirmatory safety and effectiveness data. The Zenith TX2 Low Profile TAA Endovascular Graft is indicated for the treatment of patients with a descending thoracic aortic aneurysm or penetrating ulcer and has an anatomy suitable for repair.

NCT ID: NCT02477891 Approved for marketing - Multiple Myeloma Clinical Trials

Early Access Treatment With Daratumumab for (Relapsed or Refractory) Multiple Myeloma

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

The objective of this study is to provide early access to daratumumab treatment and collect additional safety data while the medication is not commercially available or available through another protocol for subjects with multiple myeloma who have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or whose disease is double refractory to both a PI and an IMiD.

NCT ID: NCT02496689 Approved for marketing - Hypophosphatasia Clinical Trials

Expanded Access Program for Asfotase Alfa Treatment for Patients With Infantile- or Juvenile-onset Hypophosphatasia (HPP)

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

This clinical trial is being conducted in Hypophosphatasia, a bone disorder caused by gene mutation(s) resulting in bone defects. These gene mutations cause low levels of an enzyme needed to harden bone. The purpose of this study is to provide access to treatment in a disease where no approved treatment exists. This is an experimental treatment provided under specific treatment guidelines in which safety endpoints will be collected.

NCT ID: NCT02533115 Approved for marketing - Secondary AML Clinical Trials

EAP of CPX-351 (VYXEOS) for Patients 60-75 Years of Age With Secondary AML

401
Start date: n/a
Phase: N/A
Study type: Expanded Access

This study is a Phase IV Expanded Access Protocol (EAP) of CPX-351 in patients with secondary acute myeloid leukemia who are suitable for treatment with intensive chemotherapy.

NCT ID: NCT02577562 Approved for marketing - Clinical trials for Abdominal Aortic Aneurysms

Zenith® Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Continued Access Study

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

The Zenith®Fenestrated AAA Endovascular Graft Clinical Study is a clinical investigation approved by the US FDA to study the safety and effectiveness of the Zenith® Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic and aorto-iliac aneurysms.

NCT ID: NCT02592941 Approved for marketing - Clinical trials for Duchenne Muscular Dystrophy

Deflazacort Expanded Access Program for Children, Adolescents and Adults With Duchenne Muscular Dystrophy

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

The expanded access program will provide access to treatment with deflazacort in children, adolescent, and adult patients with DMD in the U.S. who are ineligible, unable, or otherwise unwilling to enroll in a clinical study examining the efficacy of deflazacort while a new drug application is under preparation and review. Enrollment is open to all eligible patients.

NCT ID: NCT02660255 Approved for marketing - Epilepsy Clinical Trials

Safety and Tolerability of Cannabidiol in Subjects With Drug Resistant Epilepsy

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

This is an observational, open-label, flexible dose study that will prospectively and longitudinally assess the effect of Cannabidiol (CBD) therapy in patients with drug-resistant epilepsies through a Physician Expanded Access Investigational New Drug protocol.