Study:
A Multicenter, Open-label Study of CMX001 Treatment of Serious Diseases or Conditions Caused by dsDNA Viruses
Rationale:
n/a
Purpose:
CMX001 is an orally administered lipid conjugate of the synthetic nucleotide analog
cidofovir (CDV). The conjugate is believed to be absorbed in the small intestine then
delivered to target organs throughout the body where it crosses cell membranes by
facilitated and passive diffusion. Inside the cell, CMX001 is cleaved by intracellular
phospholipases to release CDV which is converted to the active antiviral agent,
CDV-diphosphate (CDV-PP), by intracellular anabolic kinases. Adults and adolescents,
regardless of viral infection/disease, will have a maximum weekly dose of 200 mg i.e., 200
mg once weekly OR 100 mg twice weekly; not to exceed 4mg/kg total weekly dose. Pediatric
subjects (< 12 years), regardless of viral infection/disease, will have a maximum weekly
dose of 4 mg/kg i.e., 4 mg/kg once weekly OR 2 mg/kg twice weekly.
Study Status: Active, not recruiting
Recruiting:
n/a
| Condition |
Intervention |
Phase |
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 |
Drug: CMX001 |
Phase 2/Phase 3 |
Verified by
Chimerix
August, 2012
Sponsored by: Chimerix
Information provided by: Chimerix
ClinicalTrials.gov identifier: NCT01143181
Study Type: Interventional
Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic
Cleveland, Ohio 44195
United States
n/a