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MAP to Provide Access to Crizanlizumab, for Sickle Cell Disease Patients

2018-10-31 14:49:19 | BioPortfolio

Summary

The purpose of this Cohort Treatment Plan is to allow access to crizanlizumab (SEG101) for eligible patients diagnosed with sickle cell disease (SCD) to prevent or reduce the frequency of vaso-occlusive crises (VOC). The patient's Treating Physician should follow the suggested treatment guidelines and comply with all local health authority regulations.

Study Design

Conditions

Sickle Cell Disease

Intervention

crizanlizumab

Status

Available

Source

Novartis

Results (where available)

View Results

Links

Published on BioPortfolio: 2018-10-31T14:49:19-0400

Clinical Trials [841 Associated Clinical Trials listed on BioPortfolio]

Study of Two Doses of Crizanlizumab Versus Placebo in Adolescent and Adult Sickle Cell Disease Patients

The purpose of this study is to compare the efficacy and safety of 2 doses of crizanlizumab (5.0 mg/kg and 7.5 mg/kg) versus placebo in adolescent and adult sickle cell disease (SCD) patie...

Study of Dose Confirmation and Safety of Crizanlizumab in Pediatric Sickle Cell Disease Patients

The purpose of the Phase 2 CSEG101B2201 study is to confirm and to establish appropriate dosing and to evaluate the safety in pediatric patients ages 6 months to

Study Exploring the Effect of Crizanlizumab on Kidney Function in Patients With Chronic Kidney Disease Caused by Sickle Cell Disease

The goal of the study is to compare the efficacy and safety of crizanlizumab + standard of care to standard of care alone on renal function in sickle cell disease patients ≥ 16 years wit...

Pharmacokinetics and Pharmacodynamics Study of SEG101 (Crizanlizumab) in Adult Sickle Cell Disease (SCD) Patients With Vaso- Occlusive Crisis (VOC)

The purpose of the CSEG101A2202 study is to characterize the PK and PD of SEG101 at 5 mg/kg and to evaluate the safety and efficacy of SEG101. Study CSEG101A2202 is designed as a Phase II...

A Study to Evaluate the Safety and Efficacy of Crizanlizumab in Sickle Cell Disease Related Priapism

The goal of the study is to evaluate the efficacy and safety of crizanlizumab in SCD patients with priapism.

PubMed Articles [29573 Associated PubMed Articles listed on BioPortfolio]

Multicenter Evaluation of HemoTypeSC as a Point-of-Care Sickle Cell Disease Rapid Diagnostic Test for Newborns and Adults Across India.

Sickle cell anemia is the commonest genetic disorder in India, and the frequency of the sickle cell gene is very high in the remote tribal areas where facilities are generally limited. Therefore, a ra...

Association of the Δ Mutant Genotype with Sickle Cell Disease in Egyptian Patients.

Sickle cell disease is considered the most common single base mutation in the world, with >250,000 new patients being discovered each year. It consists of a wide spectrum of clinical presentations and...

Prevalence and factors associated with renal dysfunction among children with sickle cell disease attending the sickle cell disease clinic at a tertiary hospital in Northwestern Tanzania.

Little is known on how the interaction between Sickle Cell Disease (SCD) and renal insults caused by other coexisting conditions in Sub Saharan Africa such as urinary schistosomiasis, malnutrition and...

Web-Based Technology to Improve Disease Knowledge Among Adolescents With Sickle Cell Disease: Pilot Study.

Advancements in treatment have contributed to increased survivorship among children with sickle cell disease (SCD). Increased transition readiness, encompassing disease knowledge and self-management s...

Subperiosteal Orbital Hematoma: Imaging Findings of a Rare Complication of Sickle Cell Disease: Subperiosteal orbital hematoma is a rare entity mainly seen in pediatric patients with sickle cell disease and occurs secondary to local vascular disturbances following facial bone infarction.

Sickle cell disease is the most common hemoglobinopathy. Homozygous patients are prone to vaso-occlusive crises. A 19-year-old male patient with the homozygous sickle cell trait was admitted to the ho...

Medical and Biotech [MESH] Definitions

One of the sickle cell disorders characterized by the presence of both hemoglobin S and hemoglobin C. It is similar to, but less severe than sickle cell anemia.

An abnormal hemoglobin resulting from the substitution of valine for glutamic acid at position 6 of the beta chain of the globin moiety. The heterozygous state results in sickle cell trait, the homozygous in sickle cell anemia.

An acute purulent infection of the meninges and subarachnoid space caused by Streptococcus pneumoniae, most prevalent in children and adults over the age of 60. This illness may be associated with OTITIS MEDIA; MASTOIDITIS; SINUSITIS; RESPIRATORY TRACT INFECTIONS; sickle cell disease (ANEMIA, SICKLE CELL); skull fractures; and other disorders. Clinical manifestations include FEVER; HEADACHE; neck stiffness; and somnolence followed by SEIZURES; focal neurologic deficits (notably DEAFNESS); and COMA. (From Miller et al., Merritt's Textbook of Neurology, 9th ed, p111)

A disease characterized by chronic hemolytic anemia, episodic painful crises, and pathologic involvement of many organs. It is the clinical expression of homozygosity for hemoglobin S.

The condition of being heterozygous for hemoglobin S.

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