The Adv Halt Trial

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Chimerix

ClinicalTrials.gov Identifier:

NCT01241344

First received: November 12, 2010

Last updated: February 22, 2013

Last verified: February 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	November 12, 2010
Last Updated Date	February 22, 2013
Start Date ^ICMJE	November 2010
Estimated Primary Completion Date	March 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 15, 2010)	The primary objective of this study is to evaluate the safety and efficacy of preemptive treatment with CMX001 versus placebo for the prevention of AdV disease in recipients of HSCT with asymptomatic AdV viremia [ Designated as safety issue: Yes ] The outcome measure for the primary endpoint will be "treatment failure". Treatment failure is a composite endpoint consisting of: Progression to probable or definitive AdV disease. OR increasing AdV viremia during randomized therapy (defined as increase from baseline in AdV viremia by ≥ 1 log10, confirmed on a second measurement, at least one week apart) AND requiring discontinuation from randomized therapy
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01241344 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 15, 2010)	1. To compare the safety and efficacy of two dosing regimens of CMX001 versus each other and versus placebo in this indication. [ Designated as safety issue: Yes ] 2. To compare the incidence of treatment emergent dsDNA viral infections (other than those caused by AdV), in subjects treated with CMX001 QW versus CMX001 BIW versus placebo, initially, for the preemption of adenoviral disease. 3. To characterize the safety and efficacy of CMX001 open-label therapy in patients who meet the primary endpoint of treatment failure during randomized therapy.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Adv Halt Trial
Official Title ^ICMJE	A Randomized, Placebo-Controlled Multi-Site Phase 2 Study Evaluation the Safety and Efficacy of Preemptive Treatment With CMX001 for the Prevention of Adenovirus Disease Following Hematopoietic Stem Cell Transplantation in Adults and Children
Brief Summary	The primary objective of this study is to evaluate the safety and efficacy of preemptive treatment with CMX001 versus placebo for the prevention of AdV disease in recipients of HSCT with asymptomatic AdV viremia.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Adenovirus Disease
Intervention ^ICMJE	Drug: CMX001 Adults: 200mg CMX001 given as four 50mg tablets orally either QW OR BIW. Peds: 4mg/kg (NTE a total single dose of 200mg) given using a 5 mg/mL liquid formulation taken orally either QW OR BIW
Study Arm (s)	Active Comparator: CMX001 Adults: 200mg CMX001 given as four 50mg tablets orally either QW OR BIW. Peds: 4mg/kg (NTE a total single dose of 200mg) given using a 5 mg/mL liquid formulation taken orally either QW OR BIW Intervention: Drug: CMX001 Placebo Comparator: Placebo Adults: Two matching placebo tablets taken orally QW OR BIW. Peds: Matching liquid placebo taken orally QW OR BIW Intervention: Drug: CMX001
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	48
Completion Date	Not Provided
Estimated Primary Completion Date	March 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Males and females ≥ 3 months and ≤ 75 years of age. Subjects have received an allogeneic HSCT. Positive serum AdV PCR (> 100 copies/mL) as measured by the central laboratory. Subject or guardian(s) are willing to comply with the protocol. Subject or guardian(s) are willing and able to understand the informed consent/assent. Females of child-bearing potential must have a negative pregnancy test (serum beta-hCG) and sexually active females must use a reliable and medically approved method of contraception throughout the study. Sexually active males of procreation potential must be able and willing to use a reliable and medically approved contraceptive method throughout the study. At least one barrier method of contraception must be used, in subjects of procreation potential. Exclusion Criteria: Subject has possible, probable, or definitive AdV disease. See Appendix 2Error! Reference source not found. for a definition and criteria outlining possible, probable or definitive AdV disease. Suspected gut graft versus host disease (GVHD) that is not biopsy-proven (subjects with a biopsy performed may be included in the study). Subject has an eGFR ≤ 30 mL/minute and is not currently on dialysis. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 10 times the ULN, conjugated bilirubin > 5 times the upper limit of normal (ULN). Subject has mucositis preventing ingestion of oral medication. Subject is Human Immunodeficiency Virus (HIV) antibody positive, based upon available medical records. Subject has ocular hypotony, uveitis, or retinitis or any other intraocular pathology that would predispose the subject to one of these conditions. Subject has participated in any other investigational drug study or was exposed to an investigational drug within 14 days of enrollment. Is pregnant or breast-feeding or intending to conceive during the course of the study, including the follow-up period after drug discontinuation. Known immunologic hypersensitivity to CDV or CMX001 drug or any of its excipients. History of illicit drug use or alcohol abuse within the previous 6 months. Any medical condition that, in the opinion of the Investigator, might interfere with the subject's participation in the study, poses an added risk for the subject, or confounds the assessment of the subject (e.g. severe cardiovascular, central nervous system (CNS) or pulmonary disease). Subject has received CMX001, CDV, ribavirin, or leflunomide within the previous 14 days.
Gender	Both
Ages	3 Months to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01241344
Other Study ID Numbers ^ICMJE	CMX001-202
Has Data Monitoring Committee	Not Provided
Responsible Party	Chimerix
Study Sponsor ^ICMJE	Chimerix
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Chimerix
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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