Clinical trials: Acute Phase Response
Philadelphia Chromosome Positive (PH+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
A Randomized Phase III Study to Assess the Effect of a Longer Duration of Consolidation Treatment With Nilotinib on TFR in CP CML.
This study aimed to assess the optimal duration of nilotinib 300 mg twice daily (BID) consolidation treatment in patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML), in order that patients remained…
- Trial name
- ENESTPath (NCT01743989)
- Testing
- Nilotinib
- Where
- 208 sites in Austria, Belgium and 19 more
- Volunteers
- 620 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Myelogenous Leukemia (CML), Metastatic Gastrointestinal Stromal Tumors (GIST)
Study to Allow Access to Nilotinib for Patients Who Are on Nilotinib Treatment in a Novartis-sponsored Study
The purpose of this study was to allow continued use of nilotinib in patients who were on nilotinib treatment in a Novartis-sponsored, Oncology Clinical Development \& Medical Affairs (CD\&MA) study and were benefiting from the…
- Conditions
- Chronic Myelogenous Leukemia (CML), Metastatic Gastrointestinal Stromal Tumors (GIST), Acute Lymphoblastic Leukemia (ALL), Receptor Tyrosine Kinase (KIT) Mutated Melanoma
- Trial name
- NCT01735955
- Testing
- Nilotinib
- Where
- 33 sites in United States, Austria and 14 more
- Volunteers
- 57 people
- Sponsor
- Novartis Pharmaceuticals
Steroid-Refractory Acute Graft Versus Host Disease
A Study to Compare T-Guard vs Ruxolitinib for Treatment of Steroid-Refractory Acute Graft-vs-Host Disease (BMT CTN 2002)
This is an open-label, randomized, Phase 3, multicenter trial, which has been designed to compare the efficacy and safety of T-Guard to ruxolitinib in patients with Grade III or IV Steroid-Refractory acute Graft-Versus-Host…
- Trial name
- 2002 (NCT04934670)
- Testing
- T-Guard, Ruxolitinib
- Where
- 48 sites in United States, Belgium and 7 more
- Volunteers
- 12 people
- Sponsor
- Xenikos
Skin and Subcutaneous Tissue Bacterial Infections
A Study to Assess Objective Endpoint Measurements of Response in Bacterial Skin Infections
The purpose of this study is to compare clinical response to the measurement techniques of several objective measures of clinical efficacy for use in future ABSSSI (Acute Bacterial Skin and Skin Structure Infection) clinical…
- Trial name
- NCT01283581
- Testing
- Delafloxacin, Linezolid, Vancomycin
- Where
- 31 sites in United States
- Volunteers
- 256 people
- Sponsor
- Melinta Therapeutics, Inc.
Bloodstream Infections (BSI) Due to CRE, Hospital-Acquired Bacterial Pneumonia (HABP) Due to CRE
A Study of Plazomicin Compared With Colistin in Patients With Infection Due to Carbapenem-Resistant Enterobacteriaceae (CRE)
This was a Phase 3 study containing a randomized open-label superiority cohort (Cohort 1) comparing the efficacy and safety of plazomicin with colistin when combined with a second antibiotic (either meropenem or tigecycline) in…
- Conditions
- Bloodstream Infections (BSI) Due to CRE, Hospital-Acquired Bacterial Pneumonia (HABP) Due to CRE, Ventilator-Associated Bacterial Pneumonia (VABP) Due to CRE, Complicated Urinary Tract Infection (cUTI) Due to CRE
- Trial name
- CARE (NCT01970371)
- Testing
- plazomicin, colistin, meropenem
- Volunteers
- 69 people
- Sponsor
- Achaogen, Inc.
Acute Bipolar Mania
Study of the Broad Clinical Benefit for Seroquel XR With Flexible Dose as an add-on Therapy in the Treatment of Acute Bipolar Mania Patients With Partial Response to Current Therapy
The primary objective of this study is to evaluate the broad clinical benefit of dosing Seroquel XR with flexible in the treatment of acute bipolar mania patients with partial response to existing therapy.
- Trial name
- RELEASE (NCT01128114)
- Testing
- Quetiapine fumarate (Seroquel XR)
- Where
- 11 sites in South Korea
- Volunteers
- 32 people
- Sponsor
- AstraZeneca
Acute Myeloid Leukemia
CNDO-109-AANK for AML in First Complete Remission (CR1)
This is a multi-center, open-label, non-controlled, non-randomized dose-escalating Phase 1 clinical study designed to examine the safety of infusing escalating doses of CNDO-109-Activated Allogeneic Natural Killer Cells-(from a…
- Trial name
- NCT01520558
- Testing
- CNDO-109-AANK Cells
- Where
- 4 sites in United States
- Volunteers
- 12 people
- Sponsor
- Coronado Biosciences, Inc.
Hypertension, Pulmonary
A Research Study To Assess The Effectiveness And Safety Of Different Doses Of Oral PF-00489791 In The Treatment Of Adult Patients With Pulmonary Arterial Hypertension
Study will assess PF-00489791 efficacy and safety in Pulmonary Arterial Hypertension (PAH)
- Trial name
- NCT00853112
- Testing
- PF-00489791, sildenafil
- Where
- 25 sites in United States, Canada and 6 more
- Volunteers
- 48 people
- Sponsor
- Pfizer
Uncomplicated Urinary Tract Infections, Urinary Tract Infections
Safety, Tolerability, Pharmacokinetic and Microbiological Investigation of GSK3882347 in Female Participants With Urinary Tract Infections
This phase 1b study is a double-blind, double-dummy, nitrofurantoin-controlled study designed to evaluate microbiological response at the test of cure (ToC) visit along with safety, tolerability and pharmacokinetic (PK) response…
- Trial name
- NCT05138822
- Testing
- GSK3882347, Nitrofurantoin
- Where
- 15 sites in United States
- Volunteers
- 140 people
- Sponsor
- GlaxoSmithKline
Leukemia
A Study of Imatinib and Nilotinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase
The extension study followed the core study CAMN107ECN02 (NCT01275196). which is an open-label, two armed study. All patients enrolled in this extension study were able to benefit from the treatment given in CAMN107ECN02 per…
- Trial name
- NCT02272777
- Testing
- Imatinib, Nilotinib
- Where
- 12 sites in China
- Volunteers
- 225 people
- Sponsor
- Novartis Pharmaceuticals
Opioid Dependence, Acute Opioid Withdrawal Syndrome
Efficacy, Safety and Dose-Response Study Followed by Open-Label Study of Lofexidine Treatment of Opioid Withdrawal
The purpose of this study is to look at the efficacy and safety for lofexidine hydrochloride, an alpha-2 adrenergic agonist under development for the treatment of acute withdrawal from short-acting opioids.
- Trial name
- NCT01863186
- Testing
- Lofexidine HCl, Open Label Lofexidine HCL
- Where
- 18 sites in United States
- Volunteers
- 603 people
- Sponsor
- USWM, LLC (dba US WorldMeds)
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
WT1 Vaccine Treatment of Patients in Remission From Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL)
This trial will assess the safety and efficacy of vaccination with galinpepimut-S (GPS), a WT1 peptide vaccine, in patients who are in complete remission from leukemia.
- Trial name
- NCT01266083
- Testing
- Galinpepimut-S, GM-CSF, Montanide
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Sellas Life Sciences Group
Acute Malaria
Phase IIa Proof of Concept Study of M5717-Pyronaridine in Adults and Adolescents With Acute Uncomplicated Plasmodium Falciparum Malaria (CAPTURE 1)
The purpose of this study was to evaluate the safety, efficacy, and pharmacokinetic of the combination M5717 plus pyronaridine in participants with acute uncomplicated Plasmodium falciparum malaria.
- Trial name
- NCT05689047
- Testing
- M5717 330 mg, M5717 500 mg, M5717 660 mg
- Where
- 5 sites in Burkina Faso, Gabon and 2 more
- Volunteers
- 38 people
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Blast Phase Philadelphia Chromosomes Positive (Ph+) Chronic Myelogenous Leukemia (CML), Philadelphia Chromosome Positive (Ph+) Acute Lymphocytic Leukemia (ALL)
Growth Factor Signature (GFS) Pilot Study (MK0000-098)(COMPLETED)
This study will evaluate a gene expression signature (Growth Factor Signature [GFS]) as a biomarker for response/resistance to BRC-ABL oncogene inhibitors.
- Trial name
- NCT00860535
- Testing
- Comparator: Biomarker evaluation
- Volunteers
- 9 people
- Sponsor
- Merck Sharp & Dohme LLC
Acute Kidney Injury
A Safety, Tolerability, Efficacy and QoL Study of Human recAP in the Treatment of Patients With SA-AKI
The purpose of this study is to determine whether recombinant Alkaline Phosphatase (recAP) is effective and save, and to determine the most effective dose, in the treatment of patients with acute kidney injury caused by sepsis.
- Trial name
- STOP-AKI (NCT02182440)
- Testing
- recAP
- Where
- 58 sites in United States, Austria and 9 more
- Volunteers
- 301 people
- Sponsor
- AM-Pharma
Leukemia, Myeloid, Acute
Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia (AML) in Complete Remission
This study enrolled 472 participants, aged 55 or older, with a diagnosis of de novo acute myeloid leukemia (AML) or AML secondary to prior myelodysplastic disease or chronic myelomonocytic leukemia (CMML), and who have achieved…
- Trial name
- QUAZAR AML-001 (NCT01757535)
- Testing
- Oral Azacitidine
- Where
- 223 sites in United States, Australia and 21 more
- Volunteers
- 472 people
- Sponsor
- Celgene
Acute Kidney Injury Due to Sepsis
Pharmacokinetics and Safety of TIN816 in Patients With Sepsis-associated Acute Kidney Injury
The purpose of this study was to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile and to evaluate the safety and tolerability of TIN816 in hospitalized adult participants in an intensive care setting with a…
- Trial name
- NCT05507437
- Testing
- TIN816 70 mg lyophilisate powder
- Where
- 7 sites in Belgium, France and 3 more
- Volunteers
- 20 people
- Sponsor
- Novartis Pharmaceuticals
Acute Respiratory Distress Syndrome, Cytokine Release Syndrome
Efficacy and Safety of Itolizumab in COVID-19 Complications
Randomized, Parallel Group, Active Controlled Trial
- Conditions
- Acute Respiratory Distress Syndrome, Cytokine Release Syndrome, Covid19
- Trial name
- NCT04475588
- Testing
- Itolizumab IV infusion, Best supportive care (BSC)
- Where
- 4 sites in India
- Volunteers
- 32 people
- Sponsor
- Biocon Limited
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
A Study of the Safety and Preliminary Efficacy of Oral Midostaurin (PKC412) in Relapsed or Refractory Pediatric Leukemia
This is a phase I/II pediatric dose-ranging study that will evaluate the safety, tolerability, clinical response, pharmacokinetics and pharmacodynamics of midostaurin in patients <18 years of age who have relapsed or refractory…
- Trial name
- NCT00866281
- Testing
- midostaurin
- Where
- 8 sites in United States, France and 3 more
- Volunteers
- 22 people
- Sponsor
- Novartis Pharmaceuticals
Urinary Tract Infection Complicated, Acute Pyelonephritis
Efficacy, Safety, Tolerability of Vabomere Compared to Best Available Therapy in Treating Serious Infections in Adults
Vabomere™, (meropenem-vaborbactam) is being compared to the Best Available Therapy in the treatment of adults with selected serious infections due to Carbapenem Resistant Enterobacteriaceae
- Conditions
- Urinary Tract Infection Complicated, Acute Pyelonephritis, Hospital Acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia
- Trial name
- NCT02168946
- Testing
- Vabomere, Best Available Therapy
- Where
- 50 sites in United States, Argentina and 6 more
- Volunteers
- 77 people
- Sponsor
- Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)