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PubMed Journals Articles About "Apellis Pharmaceuticals Announces That Primary Endpoint Phase Study" RSS

10:33 EST 16th December 2018 | BioPortfolio

Apellis Pharmaceuticals Announces That Primary Endpoint Phase Study PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest Apellis Pharmaceuticals Announces That Primary Endpoint Phase Study articles that have been published worldwide.

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Showing "Apellis Pharmaceuticals Announces that Primary Endpoint Phase Study" PubMed Articles 1–25 of 70,000+

Phase II trial design with growth modulation index as the primary endpoint.

Molecularly targeted, genomic-driven, and immunotherapy-based clinical trials continue to be advanced for the treatment of relapse or refractory cancer patients, where the growth modulation index (GMI) is often considered a primary endpoint of treatment efficacy. However, there little literature is available that considers the trial design with GMI as the primary endpoint. In this article, we derived a sample size formula for the score test under a log-linear model of the GMI. Study designs using the derive...


Assessment of the Impact of an Endpoint Committee in the Ocular Hypertension Treatment Study.

To assess the impact of a masked Endpoint Committee on estimates of the incidence of primary open angle glaucoma (POAG), treatment efficacy and statistical power of the Ocular Hypertension Treatment Study-Phase 1, 1994-2002 (OHTS-1).

Quantitative decision-making in randomized Phase II studies with a time-to-event endpoint.

One of the most critical decision points in clinical development is Go/No-Go decision-making after a proof-of-concept study. Traditional decision-making relies on a formal hypothesis testing with control of type I and type II error rates, which is limited by assessing the strength of efficacy evidence in a small isolated trial. In this article, we propose a quantitative Bayesian/frequentist decision framework for Go/No-Go criteria and sample size evaluation in Phase II randomized studies with a time-to-even...


A Bayesian design for phase I cancer therapeutic vaccine trials.

Phase I clinical trials are the first step in drug development to test a new drug or drug combination on humans. Typical designs of Phase I trials use toxicity as the primary endpoint and aim to find the maximum tolerable dosage. However, these designs are poorly applicable for the development of cancer therapeutic vaccines because the expected safety concerns for these vaccines are not as much as cytotoxic agents. The primary objectives of a cancer therapeutic vaccine phase I trial thus often include deter...

Assessment of Multi-Ion Channel Block in a Phase-1 Randomized Study Design:Results of the CiPA Phase 1 ECG Biomarker Validation Study.

Balanced multi-ion channel-blocking drugs have low torsade risk because they block inward currents. The Comprehensive in vitro Proarrhythmia Assay (CiPA) initiative proposes to use an in-silico cardiomyocyte model to determine the presence of balanced block, and absence of J-Tpeakc prolongation would be expected for balanced blockers. This study included 3 balanced blockers in a 10-subject per drug parallel-design; lopinavir/ritonavir and verapamil met the primary endpoint of ΔΔJ-Tpeakc upper bound

Spatial distribution of pharmaceuticals in conventional wastewater treatment plant with Sludge Treatment Reed Beds technology.

Pharmaceutical residues are an emerging environmental problem. It is strongly confirmed that pharmaceuticals are present in soils and environmental waters (surface, marine and even groundwater), and that wastewater treatment plant (WWTP) effluents are the main source of pharmaceuticals in the watershed. The aim of this study was to recognize the spatial distribution and seasonal changes of selected pharmaceuticals in conventional WWTP with Sludge Treatment Reed Beds (STRBs) technology used for dewatering an...

Fulranumab as Adjunctive Therapy for Cancer-Related Pain: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study.

This randomized, double-blind (DB), placebo-controlled, phase 2 study assessed the efficacy and safety of fulranumab as a pain therapy adjunctive to opioids in terminally-ill cancer patients. Ninety-eight patients were randomized (2:1) to receive one subcutaneous injection of fulranumab (9 mg) or placebo in the 4-week DB phase. Seventy-one (72%) patients entered the 48-week open-label extension phase and were administered 9 mg fulranumab every 4 weeks. The study failed to demonstrated efficacy at the end of...

A randomized, double-blind, placebo-controlled phase 3 trial of oral brincidofovir for cytomegalovirus prophylaxis in allogeneic hematopoietic-cell transplantation.

Cytomegalovirus (CMV) infection is a common complication of allogeneic hematopoietic-cell transplantation (HCT). In this trial we randomized adult CMV-seropositive HCT patients without CMV viremia at screening 2:1 to receive brincidofovir or placebo until Week 14 post-HCT. Randomization was stratified by center and risk of CMV infection. Patients were assessed weekly through Week 15 and every third week thereafter through Week 24 post-HCT. Patients who developed clinically-significant CMV infection (CS-CMVi...

Safety, efficacy, and dose response of the maturation inhibitor GSK3532795 (formerly known as BMS-955176) plus tenofovir/emtricitabine once daily in treatment-naive HIV-1-infected adults: Week 24 primary analysis from a randomized Phase IIb trial.

GSK3532795 (formerly known as BMS-955176) is a second-generation maturation inhibitor targeting a specific Gag cleavage site between capsid p24 and spacer peptide 1 of HIV-1. Study 205891 (previously AI468038) investigated the efficacy, safety, and dose response of GSK3532795 in treatment-naive, HIV-1-infected participants. Study 205891 (NCT02415595) was a Phase IIb, randomized, active-controlled, double-blind, international trial. Participants were randomized 1:1:1:1 to one of three GSK3532795 arms at dose...

Efficacy and safety of secukinumab treatment in adults with extensive alopecia areata.

Alopecia areata (AA) is a common form of non-scarring hair loss. The pathogenesis of AA is believed to involve multiple inflammatory cytokines, including possibly IL-17A. To assess the efficacy and safety of the IL-17A antagonist secukinumab in AA, we conducted a double-blinded, randomized prospective pilot study in which 11 subjects were treated with either secukinumab (n = 7) or placebo (n = 4) subcutaneously at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter until (inclusive of) week 20. The pr...

Comparison of three sample size calculation methods for non-inferiority vaccine trials with multiple continuous co-primary endpoints.

Clinical trials that study immunogenicity of combination vaccines often have less power than desirable. To make up for the reduction in statistical power at the study level, researchers have to increase the study sample size. To study immunogenicity variables, we used the geometric mean concentration of immune response after vaccination as immunologic endpoint and compared 3 sample size calculation methods: the "Inflation factors" method, the "Incrementing" method, and the "Bonferroni correction" method whe...

Seasonal occurrence and fate of chiral pharmaceuticals in different sewage treatment systems in Hong Kong: Mass balance, enantiomeric profiling, and risk assessment.

Concern about the presence of chiral pharmaceuticals in the environment from wastewater discharge is mounting. In this work, the occurrence and fate of atenolol, metoprolol, venlafaxine, and chloramphenicol, including 10 different stereoisomers, were investigated in sewage and sludge from diverse treatment processes in 4 sewage treatment plants (STPs) in Hong Kong via 4 sampling campaigns over a period of 2 years. The average amounts of individual pharmaceuticals entering the STPs ranged from 4.91 g/d to ...

New toxicogenetic insights and ranking of the selected pharmaceuticals belong to the three different classes: A toxicity estimation to confirmation approach.

Tetracycline hydrochloride (TH), indomethacin (IM), and bezafibrate (BF) belong to the three different important classes of pharmaceuticals, which are well known for their toxicity and environmental concerns. However, studies are still elusive to highlight the mechanistic toxicity of these pharmaceuticals and rank them using both, the toxicity prediction and confirmation approaches. Therefore, we employed the next generation toxicity testing in 21st century (TOX21) tools and estimated the in vitro/vivo toxi...

PD-1 Blockade with Cemiplimab in Advanced Cutaneous Squamous-Cell Carcinoma.

Background No systemic therapies have been approved for the treatment of advanced cutaneous squamous-cell carcinoma. This cancer may be responsive to immune therapy, because the mutation burden of the tumor is high and the disease risk is strongly associated with immunosuppression. In the dose-escalation portion of the phase 1 study of cemiplimab, a deep and durable response was observed in a patient with metastatic cutaneous squamous-cell carcinoma. Methods We report the results of the phase 1 study of cem...

Adverse effects of two pharmaceuticals acetaminophen and oxytetracycline on life cycle parameters, oxidative stress, and defensome system in the marine rotifer Brachionus rotundiformis.

To investigate the adverse effect of two widely used pharmaceuticals, paracetamol (acetaminophen [APAP]) and oxytetracycline (OTC) on the marine rotifer Brachionus rotundiformis (B. rotundiformis), the animals were exposed to various environmentally-relevant concentrations. Up to date, acetaminophen and oxytetracycline have been considered as toxic, if used above threshold concentration, i.e. overdosed. However, this study demonstrated these two pharmaceuticals even at low concentration (i.e., μg/L scale) ...

Phase I/II Trial of Chemotherapy with Docetaxel, Cisplatin, and S-1 for Unresectable Advanced Squamous Cell Carcinoma of the Esophagus.

Our previous trial with a docetaxel, cisplatin, and 5-fluorouracil (DCF) regimen showed high response rates in metastatic squamous cell carcinoma of the esophagus (SCCE). The observed increased toxicity of the DCF regimen, however, was clinically harmful. S-1, an oral anticancer drug, has been approved as a combination therapy for SCCE, and alternate-day regimen with S-1 has shown lower levels of toxicity. This prospective single-center phase I/II trial examines the efficacy and toxicity of a combination of...

Efficacy and Safety of Sunitinib in Patients With Well-Differentiated Pancreatic Neuroendocrine Tumours.

Background: In a phase III study, sunitinib led to a significant increase in progression- free survival (PFS) vs. placebo in patients with pancreatic neuroendocrine tumours (panNETs). This study was a post-marketing commitment to support the phase III data. Methods: In this ongoing, open-label, phase IV trial (NCT01525550), patients with progressive, advanced unresectable/metastatic, well-differentiated panNETs received continuous sunitinib 37.5 mg once daily. Eligibility criteria were similar to the phase ...

FDA Approval of Angiotensin II for the Treatment of Hypotension in Adults with Distributive Shock.

Distributive shock is a subset of shock marked by decreased systemic vascular resistance, organ hypoperfusion and altered oxygen extraction. Despite the use of intravenous fluids and either higher dose of catecholamines or other additional exogenous vasopressors to maintain blood pressure in the target range, the rate of mortality remains higher in patients with septic shock. Therefore, there is clearly an unmet need for additional safe and effective treatments. The use of angiotensin II to raise the mean a...

Rationale and design of the Pemafibrate to Reduce Cardiovascular Outcomes by Reducing Triglycerides in Patients with Diabetes (PROMINENT) study.

Observational, genetic, and experimental data indicate that triglyceride rich lipoproteins (TRLs) likely participate causally in atherothrombosis. Yet, robust clinical trial evidence that triglyceride (TG) lowering therapy reduces cardiovascular events remains elusive. The selective peroxisome proliferator-activated receptor alpha modulator (SPPARM-α), pemafibrate, will be used to target residual cardiovascular risk remaining after treatment to reduce low-density lipoprotein cholesterol (LDL-C) in individu...

Comparison of the etiological relevance of Staphylococcus haemolyticus and Staphylococcus hominis.

The study was performed to assess potential differences in the etiological relevance of two coagulase-negative staphylococci (CoNS), Staphylococcus haemolyticus and Staphylococcus hominis, in an observational single-center study. Over a 5-year interval, patients in whom there was detected S. haemolyticus or S. hominis of presumed etiological relevance were assessed for the primary endpoint death during hospital stay and the secondary endpoint transfer to an intensive care unit (ICU) after the detection of S...

Distribution and fate of pharmaceuticals and their metabolite conjugates in a municipal wastewater treatment plant.

Some pharmaceutical conjugates can be excreted into wastewaters at levels rivalling those of the parent compounds; however, little is known about this potential reservoir of pharmaceuticals to aquatic systems. We evaluated the occurrence and distribution of four different classes of pharmaceuticals and their metabolite conjugates in a wastewater treatment plant over four months. Aqueous and suspended solids fractions of primary, mixed liquor, secondary, and final effluent, along with return activated sludge...

Elotuzumab monotherapy in patients with smouldering multiple myeloma: a phase 2 study.

Smouldering multiple myeloma (SMM) is associated with increased risk of progression to multiple myeloma within 2 years, with no approved treatments. Elotuzumab has been shown to promote natural killer (NK) cell stimulation and antibody-dependent cellular cytotoxicity (ADCC) in vitro. CD56 (CD56 /CD16 /CD3 /CD45 ) NK cells represent the primary subset responsible for elotuzumab-induced ADCC. In this phase II, non-randomized study (NCT01441973), patients with SMM received elotuzumab 20 mg/kg intravenously ...

Swimming activity in zebrafish larvae exposed to veterinary antiparasitic pharmaceuticals.

Veterinary antiparasitic pharmaceuticals have been detected in surface waters and several of these pharmaceuticals act on the nervous system on the target organisms implying that neurological effects also might be of concern in non-target animals such as fish. We tested if exposure to antiparasitic pharmaceuticals affect swimming activity in 6 days old zebrafish larvae. The results revealed that most pharmaceuticals did not cause any effects in swimming activity. However, larvae exposed to 0.58 mg/L doram...

Comparison of dural peeling versus duraplasty for surgical treatment of Chiari type I malformation: results and complications in a monocentric patients' cohort.

Chiari malformation type I (CM-I) is featured by the downwards herniation of the cerebellar tonsils through the foramen magnum which can impede cerebrospinal fluid (CSF) circulation and may lead to syringomyelia. Usual symptoms in the condition are neck pain and posterior headaches at Valsalva maneuver. Different surgical procedures have been described for cranio-cervical decompression (CCD), without reaching a consensus about the best suited technique. The primary endpoint of this study was to compare effi...

Downstream Change of the Primary Endpoint in the ISCHEMIA Trial: the Elephant in the Room.


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