Clinical trials: Untreated
Hemophilia B
Study to Determine the Safety and Efficacy of rFIXFc in Previously Untreated Males With Severe Hemophilia B
The primary objective of the study was to evaluate the safety of recombinant coagulation factor IX Fc fusion protein (rFIXFc, BIIB029) in previously untreated patients (PUPs) with severe hemophilia B.
- Trial name
- PUPs B-LONG (NCT02234310)
- Testing
- rFIXFc
- Where
- 27 sites in United States, Australia and 9 more
- Volunteers
- 33 people
- Sponsor
- Bioverativ, a Sanofi company
Partial Onset Seizures
Study for Verification of Efficacy and Safety for Perampanel Monotherapy in Untreated Participants With Partial Onset Seizures (Including Secondarily Generalized Seizures (FREEDOM Study)
This study is conducted to evaluate the seizure-free rate of the 26-week Maintenance Period in untreated participants with partial onset seizures (POS).
- Trial name
- NCT03201900
- Testing
- E2007
- Where
- 38 sites in Japan, South Korea
- Volunteers
- 91 people
- Sponsor
- Eisai Co., Ltd.
Anaplastic Astrocytoma, Brain Stem Glioma
Veliparib, Radiation Therapy, and Temozolomide in Treating Younger Patients With Newly Diagnosed Diffuse Pontine Gliomas
This phase I/II trial studies the side effects and the best dose of veliparib when given together with radiation therapy and temozolomide and to see how well they work in treating younger patients newly diagnosed with diffuse…
- Conditions
- Anaplastic Astrocytoma, Brain Stem Glioma, Childhood Mixed Glioma, Fibrillary Astrocytoma
- Trial name
- NCT01514201
- Testing
- 3-Dimensional Conformal Radiation Therapy, Intensity-Modulated Radiation Therapy, Laboratory Biomarker Analysis
- Where
- 12 sites in United States
- Volunteers
- 66 people
- Sponsor
- National Cancer Institute (NCI)
Melanoma
Phase II Safety Study of Vemurafenib Followed by Ipilimumab in Subjects With V600 BRAF Mutated Advanced Melanoma
The purpose of this study is to assess the safety profile of vemurafenib, 960 mg, administered for 6 weeks, followed by ipilimumab monotherapy in patients with BRAF V600 mutated advanced/metastatic melanoma.
- Trial name
- NCT01673854
- Testing
- Ipilimumab, Vemurafenib
- Where
- 14 sites in United States
- Volunteers
- 70 people
- Sponsor
- Bristol-Myers Squibb
Hemophilia A
Efficacy and Safety Study of a Recombinant Protein-Free Manufactured Factor VIII (rAHF-PFM) in Previously Untreated Hemophilia A Patients
The purpose of this study is to evaluate whether Antihemophilic factor, recombinant, manufactured protein-free (rAHF-PFM) is effective and safe in the treatment of hemophilia A patients who have not been treated with factor VIII…
- Trial name
- NCT00157157
- Testing
- Recombinant Antihemophilic Factor Manufactured and Formulated without Added Human or Animal Proteins (rAHF-PFM)
- Where
- 35 sites in United States, Austria and 8 more
- Volunteers
- 66 people
- Sponsor
- Baxalta now part of Shire
Brain and Central Nervous System Tumors
Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor
Drugs used in chemotherapy, such as vincristine, cisplatin, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die.
- Trial name
- NCT00085202
- Testing
- filgrastim, cisplatin, cyclophosphamide
- Where
- 9 sites in United States, Australia and 1 more
- Volunteers
- 416 people
- Sponsor
- St. Jude Children's Research Hospital
Leukemia, Lymphoma
Cyproheptadine Hydrochloride and Nutritional Supplementation in Treating Young Patients With Weight Loss With Cancer
RATIONALE: Cyproheptadine hydrochloride may help improve appetite and lessen weight loss caused by cancer or cancer treatment. It is not yet known whether cyproheptadine hydrochloride is more effective with or without nutritional…
- Conditions
- Leukemia, Lymphoma, Malnutrition, Myelodysplastic Syndromes
- Trial name
- NCT00949117
- Testing
- Ensure, PediaSure, cyproheptadine hydrochloride
- Volunteers
- 9 people
- Sponsor
- University of South Florida
Common Variable Immunodeficiency, Agammaglobulinemia
Efficacy and Safety of Vivaglobin® in Previously Untreated Patients With Primary Immunodeficiency
The objective of this study is to assess the efficacy and safety of Vivaglobin in previously untreated patients (PUPs) with primary immunodeficiency (PID) over a 25-week observation period.
- Trial name
- NCT00520494
- Testing
- Vivaglobin
- Where
- 6 sites in Canada, Germany and 2 more
- Volunteers
- 18 people
- Sponsor
- CSL Behring
Adult Rhabdomyosarcoma, Embryonal Childhood Rhabdomyosarcoma
Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma
This phase III trial is studying how well combination chemotherapy and radiation therapy work in treating patients with newly diagnosed low-risk rhabdomyosarcoma.
- Conditions
- Adult Rhabdomyosarcoma, Embryonal Childhood Rhabdomyosarcoma, Embryonal-botryoid Childhood Rhabdomyosarcoma, Previously Untreated Childhood Rhabdomyosarcoma
- Trial name
- NCT00075582
- Testing
- conventional surgery, dactinomycin, cyclophosphamide
- Where
- 163 sites in United States, Australia and 4 more
- Volunteers
- 390 people
- Sponsor
- Children's Oncology Group
Epilepsy
Clinical Study of Lamotrigine to Treat Newly Diagnosed Epilepsy
This is a multi-center, uncontrolled, open-label study conducted in Japan and South Korea to evaluate the efficacy and safety of lamotrigine monotherapy in subjects with newly diagnosed epilepsy and those with recurrent epilepsy…
- Trial name
- NCT01431963
- Testing
- Lamictal
- Where
- 13 sites in Japan, South Korea
- Volunteers
- 70 people
- Sponsor
- GlaxoSmithKline
Adult Rhabdomyosarcoma, Childhood Alveolar Rhabdomyosarcoma
Temozolomide, Cixutumumab, and Combination Chemotherapy in Treating Patients With Metastatic Rhabdomyosarcoma
This randomized pilot clinical trial is studying the side effects and how well giving temozolomide and cixutumumab together with combination chemotherapy works in treating patients with metastatic rhabdomyosarcoma.
- Conditions
- Adult Rhabdomyosarcoma, Childhood Alveolar Rhabdomyosarcoma, Childhood Embryonal Rhabdomyosarcoma, Metastatic Childhood Soft Tissue Sarcoma
- Trial name
- NCT01055314
- Testing
- Cixutumumab, Cyclophosphamide, Dactinomycin
- Where
- 139 sites in United States, Australia and 2 more
- Volunteers
- 175 people
- Sponsor
- National Cancer Institute (NCI)
Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma
Bevacizumab, Radiation Therapy, and Cisplatin in Treating Patients With Previously Untreated Locally Advanced Cervical Cancer
This phase II trial is studying how well giving bevacizumab together with radiation therapy and cisplatin works in treating patients with previously untreated locally advanced cervical cancer.
- Conditions
- Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Stage IB Cervical Cancer AJCC v6 and v7
- Trial name
- NCT00369122
- Testing
- Bevacizumab, Cisplatin, External Beam Radiation Therapy
- Where
- 106 sites in United States, Canada
- Volunteers
- 60 people
- Sponsor
- National Cancer Institute (NCI)
Leukemia
Nilotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
RATIONALE: Nilotinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or…
- Trial name
- NCT00844298
- Testing
- Nilotinib+mVPD
- Where
- 16 sites in South Korea
- Volunteers
- 91 people
- Sponsor
- Asan Medical Center
Brain and Central Nervous System Tumors
Risk-Adapted Therapy for Young Children With Embryonal Brain Tumors, Choroid Plexus Carcinoma, High Grade Glioma or Ependymoma
RATIONALE: In this study a combination of anti-cancer drugs (chemotherapy) is used to treat brain tumors in young children. Using chemotherapy gives the brain more time to develop before radiation is given.
- Trial name
- NCT00602667
- Testing
- Induction Chemotherapy, Low-Risk Therapy, High-Risk Therapy
- Where
- 6 sites in United States, Australia
- Volunteers
- 293 people
- Sponsor
- St. Jude Children's Research Hospital
Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA
Tretinoin and Arsenic Trioxide in Treating Patients With Untreated Acute Promyelocytic Leukemia
This phase III trial studies tretinoin and arsenic trioxide in treating patients with newly diagnosed acute promyelocytic leukemia.
- Trial name
- NCT02339740
- Testing
- Arsenic Trioxide, Cytarabine, Dexamethasone
- Where
- 174 sites in United States, Australia and 4 more
- Volunteers
- 158 people
- Sponsor
- Children's Oncology Group
Adult Anaplastic Ependymoma, Adult Anaplastic Oligodendroglioma
18F-FDOPA PET/CT or PET/MRI in Measuring Tumors in Patients With Newly-Diagnosed or Recurrent Gliomas
To evaluate 18F-FDOPA PET obtained from PET/CT or PET/MRI imaging in patients with newly diagnosed or recurrent gliomas.
- Conditions
- Adult Anaplastic Ependymoma, Adult Anaplastic Oligodendroglioma, Adult Brain Stem Glioma, Adult Diffuse Astrocytoma
- Trial name
- NCT02175745
- Testing
- 18F-fluoro-dihydroxyphenylalanine, Positron emission tomography (PET), Computed tomography (CT)
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Erik Mittra
Chronic Myeloproliferative Disorders, Graft Versus Host Disease
Donor Peripheral Stem Cell Transplant in Treating Patients With Advanced Hematologic Cancer or Other Disorders
RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral stem cell transplant helps stop the growth of cancer or abnormal cells.
- Conditions
- Chronic Myeloproliferative Disorders, Graft Versus Host Disease, Leukemia, Lymphoma
- Trial name
- NCT00544115
- Testing
- busulfan, cyclophosphamide, cyclosporine
- Volunteers
- 260 people
- Sponsor
- City of Hope Medical Center
Hemophilia A
An Open Label Study to Determine the Safety and Efficacy of Replacement Factor VIII Protein (Known as rFVIIIFc) in Previously Untreated Males With Severe Hemophilia A
The primary objective of the study was to evaluate the safety of rFVIIIFc (BIIB031) in previously untreated participants (PUPs) with severe hemophilia A.
- Trial name
- NCT02234323
- Testing
- rFVIIIFc
- Where
- 71 sites in United States, Australia and 12 more
- Volunteers
- 108 people
- Sponsor
- Bioverativ, a Sanofi company
Congenital Bleeding Disorder, Haemophilia B
Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B
This trial is conducted globally. The aim of the trial is to investigate the safety and efficacy of nonacog beta pegol (N9-GP) in previously untreated patients with Haemophilia B.
- Trial name
- paradigm™6 (NCT02141074)
- Testing
- nonacog beta pegol
- Where
- 93 sites in United States, Algeria and 22 more
- Volunteers
- 54 people
- Sponsor
- Novo Nordisk A/S
Hepatitis B, Chronic
A Study of Pegasys (Peginterferon Alfa-2a) Versus Untreated Control in Children With HBeAg Positive Chronic Hepatitis B
This parallel group, open label study will evaluate the safety and efficacy of Pegasys (peginterferon alfa-2a) versus untreated control in children (age 3 years to <18 years at baseline) with HBeAg positive chronic hepatitis B.
- Trial name
- NCT01519960
- Testing
- peginterferon alfa-2a [Pegasys]
- Where
- 39 sites in United States, Australia and 10 more
- Volunteers
- 165 people
- Sponsor
- Hoffmann-La Roche