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A Multicenter, Open-label Study of CMX001 Treatment of Serious Diseases or Conditions Caused by dsDNA Viruses


Phase 2/Phase 3
1 Month
N/A
Open (Enrolling)
Both
Male or Female Patients With a Serious or Immediately Life-threatening, Disease or Condition Caused by CMV, ADV, HSV, VAVC, VARV or, Monkeypox Viruses(s) Who Have a Life Expectancy of ≥ 2 Weeks and for, Whom no Comparable or Satisfactory Alternative Therapy is Available

Thank you

Trial Information

A Multicenter, Open-label Study of CMX001 Treatment of Serious Diseases or Conditions Caused by dsDNA Viruses


Inclusion Criteria:



1. Patients with an immediately life-threatening or serious disease or condition caused
by CMV, ADV, HSV, VAVC, VARV or monkeypox viruses(s).

2. Life expectancy of at least 2 weeks and commitment to continuation of supportive care
for at least 4 weeks.

3. Able to ingest and absorb oral medication (in the judgment of the investigator and
based on lack of significant GI pathology such as small bowel resection or ileus).
[Note: Use of TPN (total parenteral nutrition) is not in and of itself exclusionary
as long as the reason for use would not disqualify the patient based on this
criterion.]

4. Willing and able to understand and provide written informed consent. For minors or
those incapable of providing written informed consent (i.e., incapacitated),
understood, written and informed consent must be provided by a parent or legal
guardian or representative.

5. To the best of his or her (or parent/guardian) knowledge, willing and able to
participate in all required study activities for the duration of the study.

6. In the judgment of the investigator, patients for whom no comparable or satisfactory
therapeutic alternative is available

Exclusion Criteria:

1. Females who are pregnant or currently nursing.

2. Patients with hypersensitivity to cidofovir or CMX001.

3. Patients whose long-term prognosis includes a poor likelihood of survival due to
irreversible organ failure including, for example, patients with frank hepatic
failure and adults with Grade 4 GVHD of the GI tract.

4. Patients who are eligible for enrollment and able to participate in a clinical trial
evaluating CMX001.

5. Patients with any other condition that would, in the judgment of the investigator,
put the patient at increased risk during participation in the study, or interfere
with the conduct of the study.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

CMX001-350

NCT ID:

NCT01143181

Start Date:

December 2010

Completion Date:

December 2012

Related Keywords:

  • Male or Female Patients With a Serious or Immediately Life-threatening
  • Disease or Condition Caused by CMV, ADV, HSV, VAVC, VARV or
  • Monkeypox Viruses(s) Who Have a Life Expectancy of ≥ 2 Weeks and for
  • Whom no Comparable or Satisfactory Alternative Therapy is Available
  • CMV, ADV, HSV, VAVC, VARV
  • life threatening
  • Virus Diseases
  • Monkeypox

Name

Location

University of IowaIowa City, Iowa  52242
University of MichiganAnn Arbor, Michigan  48109-0624
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Medical College of WisconsinMilwaukee, Wisconsin  53226
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Hackensack University Medical CenterHackensack, New Jersey  07601
Children's National Medical CenterWashington, District of Columbia  20010-2970
St. Louis Children's HospitalSaint Louis, Missouri  63110
Nationwide Children's HospitalColumbus, Ohio  43205-2696
University of MinnesotaMinneapolis, Minnesota  55455
Columbia UniversityNew York, New York  10032-3784
Duke University Medical CenterDurham, North Carolina  27710
Cleveland ClinicCleveland, Ohio  44195
University of ChicagoChicago, Illinois  60637
UT MD Anderson Cancer CenterHouston, Texas  77030
Tufts Medical CenterBoston, Massachusetts  02111
Oregon Health and Science UniversityPortland, Oregon  97201
University of North Carolina at Chapel HillChapel Hill, North Carolina  27599
Brigham and Womens HospitalBoston, Massachusetts  02115
Cook Children's Medical CenterFort Worth, Texas  76104
Childrens Hospital of PittsburghPittsburgh, Pennsylvania  15213
UCLA Department of MedicineLos Angeles, California  90005
Children's Hospital of LALos Angeles, California  90027
Lucile Packard Children's HospitalRedwood City, California  94063-5334
Loma Linda University HospitalLoma Linda, California  92354
CHOC Children'sOrange, California  92868
Univeristy of San FranciscoSan Francisco, California  94143
Children's Hospital of ColoradoAurora, Colorado  80045
Childrens Hospital LSUNew Orleans, Louisiana  70118
NIHBethesda, Maryland  20892
Memorial Sloan Kettering Cancer InstituteNew York, New York  10065
Mt. SinaiNew York, New York  10029
Levine Children's Hospital Carolina Medical CenterCharlotte, North Carolina  28203
Cincinnati Childrens HospitalCincinnati, Ohio  45229
UPMCPittsburgh, Pennsylvania  15213
Intermountain BMT program LDS HospitalSalt Lake City, Utah  84143
University of Washington-Fred Hutchinson Cancer CenterSeattle, Washington  98109