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NCT ID: NCT06331832 No longer available - Clinical trials for Relapsed/Refractory Non-Hodgkin Lymphomas

Expanded Access of Imvotamab (IGM-2323) in Patients With R/R NHL

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

Expanded Access of Imvotamab (IGM-2323) in Patients with Relapsed/Refractory Non-Hodgkin Lymphomas from IGM-2323-001 clinical trial.

NCT ID: NCT03409081 No longer available - Clinical trials for Acute Myeloid Leukemia (AML)

Early Access Program (EAP) of Gilteritinib (ASP2215) in Patients With FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or With FLT3-Mutated AML in Complete Remission (CR) With Minimal Residual Disease (MRD)

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

The purpose of this study is to provide expanded access to gilteritinib (ASP2215) for patients with FMS-like tyrosine kinase 3 (FLT3)-mutated relapsed or refractory acute myeloid leukemia (AML) or with FLT3-mutated AML in composite complete remission (CRc: [complete remission (CR), complete remission with incomplete hematologic recovery (CRi), complete remission with incomplete platelet recovery (CRp)]) with minimal residual disease (MRD) without access to comparable or alternative therapy.

NCT ID: NCT02783001 No longer available - HIV Infections Clinical Trials

Expanded Access Program for Maraviroc At Multiple Centers

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

To provide access to maraviroc to patients who have limited or no therapeutic treatment options and to collect more safety data in a broader patient population.

NCT ID: NCT02636686 No longer available - Clinical trials for Duchenne Muscular Dystrophy

Extension Study of Drisapersen in DMD Subjects

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

This is a phase IIIb, multi-centre, open-label extension study in male subjects with DMD who previously have been treated with drisapersen, aiming at assessing the safety and efficacy of drisapersen.

NCT ID: NCT02389933 No longer available - Clinical trials for Heart Failure With Reduced Ejection Fraction (HF-rEF)

Multiple Patient Program to Ensure Access to LCZ696 Treatment to Patients Diagnosed With Heart Failure With Reduced Ejection Fraction (HF-rEF)

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

Novartis has set up this global Multiple Patient Program (MPP) treatment plan to provide access to life-saving treatment with LCZ696 for patients that were not previously exposed to LCZ696 but have no other option to receive LCZ696 in their country prior to market authorization OR commercial availability, based on local regulatory and legal requirements.

NCT ID: NCT01871233 No longer available - Clinical trials for Partial Onset Seizures

An Extended Access Program for Perampanel

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

The Extended Access Program (EAP) is a managed access programme for Perampanel. The main objective of this EAP is to ensure that patients participating in studies E2007-A001-207, E2007-G000-307, or E2007-G000-235 continue to have access to perampanel until such time perampanel tablets become commercially available for the treatment of Partial Onset Seizures (POS) in the country in which they reside. This EAP will consist of 2 phases: - Screening: The patient will start the program once the Screening assessments are completed and the patient is qualified for participation. - Treatment: Additional assessments, physical examinations, and dosage changes will be clinically determined by the treating physician. Patients will enter this program on the same dose of perampanel that they were receiving at the end of their participation in previous study. Doses of perampanel and of concomitant anti-epileptic drugs (AEDs) can be adjusted (i.e., added,removed, or changed in dose) based on clinical judgment. Treatment will be prescribed as long as clinically appropriate according to the judgement of the treating physician and the approved Summary of Product Characteristics (SmPC). The program will complete in a staggered fashion, country by country, as and when perampanel becomes commercially available for the treatment of POS in each country.

NCT ID: NCT01789151 No longer available - Clinical trials for Rheumatoid Arthritis

99m-Technetium- Glucosamine in Arthritis

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

Preliminary data following a pilot study from our institution confirms the ability of 99mTc-glucosamine (99mTc-ECDG) to differentiate between active, subclinical and quiescent disease in patients with rheumatoid arthritis, scleroderma lung, and vasculitis. We propose to extend these findings and further evaluate this imaging modality for its clinical utility, limitations, and application. An unacceptably high level of morbidity exists amongst patients suffering from rheumatic disease. This is often the result of mild disease being missed or misdiagnosed, and therapy inordinately delayed or inappropriate. The currently used therapeutic agents themselves have associated side-effects adding to unfavourable clinical outcomes. There is therefore a need for a superior, less expensive and more easily accessible imaging modality to assess the degree of inflammation to guide the clinician. Glucosamine is absorbed and metabolised in a manner not too dissimilar to that of glucose, and it can be readily labelled to form 99mTc-ECDG. Scans can be acquired within 3 hours of intravenous administration of this agent, accurately depicting sites of active inflammation/disease. HYPOTHESIS Glucose is a vital cellular substrate that accumulates at inflamed tissues because of the greater metabolic needs of the cells during active disease. Glucosamine, being an analogue of glucose, is metabolised more quickly in inflamed than non-inflamed tissue and thus 99mTc-ECDG scintigraphy like 18-Fluorodeoxyglucose (18FDG-PET) scintigraphy allows for detection of active inflammation. Unlike current bone scans this agent has the sensitivity to detect subclinical inflammatory disease that would in turn provide essential information to ensure accurate diagnosis and treatment.

NCT ID: NCT01538680 No longer available - Clinical trials for Colorectal Neoplasms

Regorafenib in Subjects With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy

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

This is a phase III B, prospective, interventional, open-label, single-arm, multicenter study to provide regorafenib to subjects diagnosed with metastatic colorectal cancer who have failed after standard therapy and for whom no therapy alternatives exist, in the time between positive results and approval / availability on the market, and to collect safety data for regorafenib until market access. Regorafenib is an oral (i.e. taken by mouth) multi-targeted kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, regorafenib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning. The primary endpoint of this study will be safety.

NCT ID: NCT01508286 No longer available - Hepatitis C Clinical Trials

Early Access Program of Telaprevir With Peginterferon and Ribavirin in Chronic Hepatitis C Subjects

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

The purpose of this early access program is to provide telaprevir to patients with a specific type of hepatitis C viral infection (termed 'genotype 1') who are expected to benefit from telaprevir-based therapy but who reside in countries in which telaprevir is not yet commercially available and who are not eligible for enrollment into a clinical study of telaprevir. The study also aims to collect information on the safety and adverse events with telaprevir treatment in combination with peginterferon alfa and ribavirin, which is typically used to treat patients with hepatitis C. In addition to hepatitis C viral infection, patients in this study will also have a diagnosis of liver fibrosis and compensated liver disease.

NCT ID: NCT01473043 No longer available - Clinical trials for Renal Cell Carcinoma

Clinical Study With Axitinib In Advanced Kidney Cancer, Who Have Failed First Line Treatment

Start date: March 2012
Phase: N/A
Study type: Expanded Access

This is a single arm study with axitinib in patients with advanced kidney cancer (clear cell variant), who have failed first line therapy. The study will recruit a maximum of 30 patients from 2 countries including Australia and Canada. Patients will be followed up for efficacy, safety and health related outcomes.