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Safety and Efficacy Study of a New Antiviral Drug to Prevent Cytomegalovirus Reactivation in Bone Marrow Transplanted Patients
This study has been completed.
Sponsor:
AiCuris Anti-infective Cures GmbH
Collaborator:
Quintiles, Inc.
Information provided by (Responsible Party):
AiCuris Anti-infective Cures GmbH
ClinicalTrials.gov Identifier:
NCT01063829
First received: February 4, 2010
Last updated: January 28, 2013
Last verified: December 2010
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Purpose
The aim of the study is to find out whether AIC246 is safe and efficacious in lowering the chances of the cytomegalovirus becoming active again and causing illness after an HBPC transplant (allogeneic stem cell transplant).
| Condition | Intervention | Phase |
|---|---|---|
| Cytomegalovirus | Drug: AIC246 Other: Placebo | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Safety, Tolerability and Antiviral Activity of 12 Weeks' Treatment With a New Antiviral HCMV Drug |
Further study details as provided by AiCuris Anti-infective Cures GmbH:
Primary Outcome Measures:
- HCMV reactivation or HCMV End-Organ Disease [ Time Frame: 92 days ]
| Enrollment: | 133 |
| Study Start Date: | February 2010 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Dose regimen 1
AIC246
|
Drug: AIC246
Oral administration
|
|
Experimental: Dose regimen 2
AIC246
|
Drug: AIC246
Oral administration
|
|
Experimental: Dose regimen 3
AIC246
|
Drug: AIC246
Oral administration
|
|
Placebo
Placebo arm
|
Other: Placebo
Oral administration
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Seropositive for HCMV IgG antibodies before transplantation
- First allogeneic Human blood precursor cell (HBPC) transplantation performed for 1 of the following diagnoses: leukaemia, lymphoma, Hodgkin's lymphoma, non-Hodgkin's lymphoma, multiple myeloma, myelodysplastic and myeloproliferative disorder
- Evidence of post transplantation engraftment
- Able to swallow tablets.
Exclusion Criteria:
- Previous anti-HCMV therapy after this allogeneic HBPC transplantation
- Mismatched or cord blood transplant recipients
- Current or history of end-organ HCMV disease
- Graft versus host disease (GVHD)
- Impaired liver function
- Reduced renal function
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01063829
Please refer to this study by its ClinicalTrials.gov identifier: NCT01063829
Locations
| United States, California | |
| UCLA Medical Center | |
| Los Angeles, California, United States | |
| Stanford University Hospital | |
| Stanford, California, United States | |
| United States, Colorado | |
| Denver St. Lukes Presbyterian | |
| Denver, Colorado, United States | |
| United States, Florida | |
| University of Florida | |
| Shands, Gainesville, Florida, United States | |
| United States, Illinois | |
| University of Chicago Medical Center | |
| Chicago, Illinois, United States | |
| Loyola University Chicago | |
| Maywood, Illinois, United States | |
| United States, Indiana | |
| Indiana BMT | |
| Beech Grove, Indiana, United States | |
| United States, Iowa | |
| University Of Iowa | |
| Iowa City, Iowa, United States | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute, | |
| Boston, Massachusetts, United States | |
| United States, Michigan | |
| Karmanos Cancer Institute | |
| Detroit, Michigan, United States | |
| United States, Minnesota | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States | |
| United States, Pennsylvania | |
| Jeanes Hospital of TUHS | |
| Philadelphia, Pennsylvania, United States | |
| UPMC Cancer Center | |
| Pittsburgh, Pennsylvania, United States | |
| United States, Texas | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States | |
| Germany | |
| Universitaetsklinikum Dresden | |
| Dresden, Germany | |
| Universitaetsklinikum Erlangen-PS | |
| Erlangen,, Germany | |
| Universitätsklinikum Freiburg | |
| Freiburg, Germany | |
| Universitaetsklinikum Hamburg-Eppendorf | |
| Hamburg, Germany | |
| Universitaeetsklinikum Heidelberg, , | |
| Heidelberg, Germany | |
| Universitaetsklinikum Mainz | |
| Mainz, Germany | |
| Universitaetsklinikum Muenster | |
| Muenster, Germany | |
| Klinikum Nuernberg Nord | |
| Nuernberg, Germany | |
| Robert-Bosch-Krankenhaus | |
| Stuttgart, Germany | |
| Universitaetsklinikum Wuerzburg | |
| Wuerzburg, Germany | |
Sponsors and Collaborators
AiCuris Anti-infective Cures GmbH
Quintiles, Inc.
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AiCuris Anti-infective Cures GmbH |
| ClinicalTrials.gov Identifier: | NCT01063829 History of Changes |
| Other Study ID Numbers: |
AIC246-01-II-02 |
| Study First Received: | February 4, 2010 |
| Last Updated: | January 28, 2013 |
Keywords provided by AiCuris Anti-infective Cures GmbH:
|
HCMV |
Additional relevant MeSH terms:
|
Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on September 19, 2017