3 фаза клинические исследования у детей (до 17 лет) при цитомегаловирусной инфекции


RankStatusStudy
1Completed
Has Results
IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients
Condition:Cytomegalovirus Infections
Intervention:Drug: Valganciclovir
Sponsor:Hoffmann-La Roche
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase III
Number Enrolled:326
Funded By:Industry
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
NCT ID:NCT00294515
Other IDs:NT18435
First Received Date:February 21, 2006
Start Date:March 2006
Completion Date:August 2009
Last Updated Date:July 30, 2010
Last Verified Date:July 2010
Acronym:IMPACT
Primary Completion Date:August 2008
Outcome Measures:Percentage of Patients Who Developed Cytomegalovirus (CMV) Disease up to Month 12 Post-transplant;   Percentage of Patients Who Developed CMV Disease up to Month 6 Post-transplant;   Percentage of Patients Who Developed CMV Disease up to Month 9 Post-transplant;   Percentage of Patients Who Developed CMV Disease up to Month 18 Post-transplant;   Percentage of Patients Who Developed CMV Disease up to Month 24 Post-transplant
2Active, not recruitingValganciclovir in Prevention of Cytomegalovirus (CMV) Reactivation Following Allogeneic-Stem Cell Transplantation (SCT)
Conditions:Bone Marrow Transplantation;   Cytomegalovirus
Interventions:Drug: Valganciclovir;   Drug: Acyclovir
Sponsor:Hadassah Medical Organization
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase III
Number Enrolled:40
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
NCT ID:NCT00330018
Other IDs:MYS-03-HMO-CTIL
First Received Date:May 24, 2006
Start Date:February 2006
Completion Date:April 2010
Last Updated Date:September 16, 2010
Last Verified Date:August 2009
Acronym:
Primary Completion Date:April 2010
Outcome Measures:Prevention of CMV reactivation;   Occurrence of CMV disease;   Overall survival;   Occurrence of GVHD;   Occurrence of other infections
3CompletedCytomegalovirus Hyperimmune Globulin (CMV-Ig) Replacement in Hypogammaglobulinemic Lung Transplant Recipients
Condition:Hypogammaglobulinemia
Intervention:Drug: CMV-Ig
Sponsor:The Cleveland Clinic
Gender:Both
Age Groups:Child / Adult / Senior
Phases:Phase II / Phase III
Number Enrolled:50
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
NCT ID:NCT00137748
Other IDs:IRB2953
First Received Date:August 29, 2005
Start Date:January 2001
Completion Date:January 2006
Last Updated Date:June 8, 2010
Last Verified Date:June 2010
Acronym:
Primary Completion Date:January 2006
Outcome Measure:CMV infection
4CompletedPreventing Cytomegalovirus (CMV) Organ Damage With Valganciclovir in People With HIV
Conditions:Cytomegalovirus Infections;   HIV Infections
Intervention:Drug: Valganciclovir
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase III
Number Enrolled:350
Funded By:NIH
Study Type:Interventional
Study Design:Endpoint Classification: Safety Study;   Masking: Double-Blind;   Primary Purpose: Prevention
NCT ID:NCT00006145
Other IDs:ACTG A5030,   AACTG A5030,   DAIDS-ES ID 10170
First Received Date:August 7, 2000
Start Date:
Completion Date:
Last Updated Date:February 23, 2011
Last Verified Date:August 2009
Acronym:
Primary Completion Date:February 2006
Outcome Measure:
5CompletedA Phase III Study to Evaluate the Safety and Efficacy of Ganciclovir (Dihydroxypropoxymethyl Guanine [DHPG]) Treatment of Symptomatic Central Nervous System (CNS) Congenital Cytomegalovirus (CMV) Infections.
Condition:Cytomegalovirus Infections
Intervention:Drug: ganciclovir
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Group:Child
Phase:Phase III
Number Enrolled:130
Funded By:NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00001100
Other IDs:DMID ARB-AL-91-CMV,   DAB-AL-558607
First Received Date:November 2, 1999
Start Date:
Completion Date:November 2005
Last Updated Date:August 26, 2010
Last Verified Date:November 2005
Acronym:
Primary Completion Date:
Outcome Measure:
6CompletedA Treatment Protocol for the Use of Intravenous Ganciclovir in AIDS Patients With Immediately Sight-Threatening CMV Retinitis
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Ganciclovir
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase III
Number Enrolled:
Funded By:NIH
Study Type:Interventional
Study Design:Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00000698
Other IDs:TX 303
First Received Date:November 2, 1999
Start Date:
Completion Date:August 2007
Last Updated Date:September 26, 2008
Last Verified Date:April 1992
Acronym:
Primary Completion Date:
Outcome Measure:
7RecruitingShort-Term vs. Long-Term Valganciclovir Therapy for Symptomatic Congenital CMV Infections
Condition:Cytomegalovirus Infections
Interventions:Drug: Valganciclovir;   Drug: Placebo
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Group:Child
Phase:Phase III
Number Enrolled:104
Funded By:NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
NCT ID:NCT00466817
Other IDs:06-0046,   CASG 112,   N01AI30025C
First Received Date:April 26, 2007
Start Date:June 2008
Completion Date:April 2014
Last Updated Date:March 24, 2011
Last Verified Date:June 2010
Acronym:
Primary Completion Date:April 2012
Outcome Measures:Change in best ear hearing assessments.;   Adverse events which lead to permanent discontinuation of valganciclovir therapy or to irreversible outcome of the adverse event.;   Neurological impairment utilizing the Bayley Scales of Infant and Toddler Development.;   Maximum change in hearing assessments over left and right ears.;   Hearing deterioration over left and right ears.
8CompletedTrial of Preemptive Treatment With Oral Valganciclovir Compared With Intravenous (IV) Ganciclovir for Cytomegalovirus Infection After Bone Marrow or Peripheral Blood Stem Cell Transplant
Condition:Cytomegalovirus Infections
Interventions:Drug: Oral Valganciclovir;   Drug: IV Ganciclovir
Sponsor:Washington University School of Medicine
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase III
Number Enrolled:120
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00241345
Other IDs:04-0274
First Received Date:October 17, 2005
Start Date:March 2004
Completion Date:February 2008
Last Updated Date:February 3, 2009
Last Verified Date:February 2009
Acronym:
Primary Completion Date:
Outcome Measures:The study end point for statistical purposes will be clearance of CMV viremia at 4 weeks from the start of therapy. Clearance of CMV viremia will be defined as a CMV viral load less than 5,000 copies/ml of whole blood.;   All patients will be followed for 6 months after randomization.
9CompletedStudies of the Ocular Complications of AIDS (SOCA)--Monoclonal Antibody CMV Retinitis Trial (MACRT)
Conditions:HIV Infections;   Cytomegalovirus Retinitis
Intervention:Drug: MSL-109
Sponsor:National Eye Institute (NEI)
Gender:Both
Age Groups:Child / Adult / Senior
Phases:Phase II / Phase III
Number Enrolled:
Funded By:NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Primary Purpose: Treatment
NCT ID:NCT00000135
Other IDs:NEI-34
First Received Date:September 23, 1999
Start Date:September 1995
Completion Date:August 1996
Last Updated Date:September 16, 2009
Last Verified Date:September 2009
Acronym:
Primary Completion Date:
Outcome Measure:
10CompletedA Comparison of Valganciclovir and Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Interventions:Drug: Valganciclovir;   Drug: Ganciclovir
Sponsor:Hoffmann-La Roche
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase III
Number Enrolled:
Funded By:Industry
Study Type:Interventional
Study Design:Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
NCT ID:NCT00002377
Other IDs:WV15376
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:July 1, 2005
Last Verified Date:July 2005
Acronym:
Primary Completion Date:
Outcome Measure:
11CompletedHigh-Frequency Oscillatory Ventilation Associated With Inhaled Nitric Oxide in Children
Condition:Acute Hypoxemic Respiratory Failure
Intervention:Procedure: High frequency oscillatory ventilation
Sponsor:UPECLIN HC FM Botucatu Unesp
Gender:Both
Group:Child
Phase:Phase III
Number Enrolled:24
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
NCT ID:NCT00924846
Other IDs:upeclin/HC/FMB-Unesp-26
First Received Date:June 18, 2009
Start Date:April 2005
Completion Date:June 2009
Last Updated Date:June 19, 2009
Last Verified Date:June 2009
Acronym:
Primary Completion Date:April 2008
Outcome Measure:Oxygenation indexes
12CompletedStudies of the Ocular Complications of AIDS (SOCA)--Foscarnet-Ganciclovir CMV Retinitis Trial (FGCRT)
Conditions:HIV Infections;   Cytomegalovirus Retinitis
Interventions:Drug: Foscarnet;   Drug: Ganciclovir
Sponsor:National Eye Institute (NEI)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase III
Number Enrolled:
Funded By:NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Primary Purpose: Treatment
NCT ID:NCT00000136
Other IDs:NEI-35
First Received Date:September 23, 1999
Start Date:March 1990
Completion Date:October 1991
Last Updated Date:September 16, 2009
Last Verified Date:September 2009
Acronym:
Primary Completion Date:
Outcome Measure:
13CompletedStudies of Ocular Complications of AIDS (SOCA)--Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT)
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Interventions:Device: Ganciclovir Intraocular Device;   Drug: Ganciclovir;   Drug: Cidofovir
Sponsor:National Eye Institute (NEI)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase III
Number Enrolled:
Funded By:NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Primary Purpose: Treatment
NCT ID:NCT00000143
Other IDs:NEI-42
First Received Date:September 23, 1999
Start Date:May 1997
Completion Date:
Last Updated Date:March 18, 2010
Last Verified Date:September 2009
Acronym:
Primary Completion Date:
Outcome Measure:
14CompletedStudies of the Ocular Complications of AIDS (SOCA)--HPMPC Peripheral CMV Retinitis Trial (HPCRT)
Conditions:HIV Infections;   Cytomegalovirus Retinitis
Intervention:Drug: Cidofovir
Sponsor:National Eye Institute (NEI)
Gender:Both
Age Groups:Child / Adult / Senior
Phases:Phase II / Phase III
Number Enrolled:
Funded By:NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Primary Purpose: Treatment
NCT ID:NCT00000142
Other IDs:NEI-41
First Received Date:September 23, 1999
Start Date:April 1994
Completion Date:February 1996
Last Updated Date:September 16, 2009
Last Verified Date:September 2009
Acronym:
Primary Completion Date:
Outcome Measure:
15CompletedThe Safety and Effectiveness of Adefovir Dipivoxil in the Treatment of HIV-Infected Patients
Conditions:Cytomegalovirus Infections;   HIV Infections
Interventions:Drug: Levocarnitine;   Drug: Adefovir dipivoxil;   Drug: Adefovir dipivoxil placebo
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase III
Number Enrolled:505
Funded By:NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
NCT ID:NCT00001082
Other IDs:CPCRA 039
First Received Date:November 2, 1999
Start Date:December 1996
Completion Date:August 1999
Last Updated Date:August 6, 2009
Last Verified Date:August 2009
Acronym:
Primary Completion Date:January 1999
Outcome Measure:Morbidity
16CompletedA Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients
Conditions:Cytomegalovirus Infections;   HIV Infections
Interventions:Drug: Valacyclovir hydrochloride;   Drug: Acyclovir
Sponsors:National Institute of Allergy and Infectious Diseases (NIAID);   Glaxo Wellcome
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase III
Number Enrolled:1200
Funded By:NIH / Industry
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00001038
Other IDs:ACTG 204,   FDA 104C
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:February 28, 2011
Last Verified Date:February 2011
Acronym:
Primary Completion Date:May 1996
Outcome Measure:
17CompletedA Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Ganciclovir
Sponsors:National Institute of Allergy and Infectious Diseases (NIAID);   Hoffmann-La Roche
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase III
Number Enrolled:180
Funded By:NIH / Industry
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00000688
Other IDs:ACTG 071,   RS-21592,   ICM 1697
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:March 11, 2011
Last Verified Date:October 1990
Acronym:
Primary Completion Date:February 1995
Outcome Measure:
18CompletedTransfusion-Transmitted Cytomegalovirus Prevention in Neonates
Conditions:Blood Transfusion;   Cytomegalovirus Infections
Intervention:Drug: immunoglobulins
Sponsor:National Heart, Lung, and Blood Institute (NHLBI)
Gender:Both
Group:Child
Phase:Phase III
Number Enrolled:
Funded By:NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Masking: Double-Blind;   Primary Purpose: Prevention
NCT ID:NCT00000584
Other IDs:304
First Received Date:October 27, 1999
Start Date:July 1983
Completion Date:
Last Updated Date:January 3, 2006
Last Verified Date:December 2005
Acronym:
Primary Completion Date:
Outcome Measure:
19CompletedGanciclovir Implant Study for Cytomegalovirus Retinitis
Conditions:HIV Infections;   Acquired Immunodeficiency Syndrome;   Cytomegalovirus Retinitis
Intervention:Device: Sustained-Release Intraocular Drug Delivery System
Sponsor:National Eye Institute (NEI)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase III
Number Enrolled:
Funded By:NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Primary Purpose: Treatment
NCT ID:NCT00000118
Other IDs:NEI-14
First Received Date:September 23, 1999
Start Date:October 1992
Completion Date:December 1993
Last Updated Date:September 16, 2009
Last Verified Date:September 2009
Acronym:
Primary Completion Date:
Outcome Measure:
20RecruitingSirolimus/Tacrolimus Versus Tacrolimus/Methotrexate for Preventing Graft-Versus-Host Disease (GVHD)
Conditions:Leukemia, Myelocytic, Acute;   Leukemia, Lymphocytic, Acute;   Leukemia, Myeloid, Chronic;   Myelodysplastic Syndromes
Interventions:Drug: Tacrolimus/methotrexate;   Drug: Tacrolimus/sirolimus
Sponsors:National Heart, Lung, and Blood Institute (NHLBI);   Blood and Marrow Transplant Clinical Trials Network;   National Cancer Institute (NCI)
Gender:Both
Age Groups:Child / Adult
Phase:Phase III
Number Enrolled:312
Funded By:NIH / Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00406393
Other IDs:385,   BMT CTN 0402,   U01 HL069294-05
First Received Date:November 30, 2006
Start Date:November 2006
Completion Date:August 2013
Last Updated Date:February 24, 2011
Last Verified Date:February 2011
Acronym:BMT CTN 0402
Primary Completion Date:August 2011
Outcome Measures:Rate of Grades II-IV acute GVHD-free survival;   Time to neutrophil engraftment;   Incidence of acute GVHD;   Mucositis severity;   Time to discharge after transplant;   Infections;   Cytomegalovirus (CMV) reactivation and thrombotic microangiopathy;   Malignant disease relapse

 Indicates status has not been verified in more than two years


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