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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chimerix
ClinicalTrials.gov Identifier:
NCT01143181
First received: June 11, 2010
Last updated: August 28, 2013
Last verified: August 2013

June 11, 2010
August 28, 2013
December 2010
December 2012   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01143181 on ClinicalTrials.gov Archive Site
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A Multicenter, Open-label Study of CMX001 Treatment of Serious Diseases or Conditions Caused by dsDNA Viruses
A Multicenter, Open-label Study of CMX001 Treatment of Serious Diseases or Conditions Caused by dsDNA Viruses

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.

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Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
CMX001 administered orally twice weekly for up to 3 months. Treatment may be extended for up to 6 months depending on the patient's clinical response.
Other Name: CMX001
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
232
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
1 Month and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01143181
CMX001-350
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Chimerix
Chimerix
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Chimerix
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP