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Safety and efficacy of cidofovir for adenovirus infection

Safety and efficacy of cidofovir for adenovirus infection - Safety and efficacy of cidofovir for adenovirus infection

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000004336
Enrollment
21
Registered
2010-10-06
Start date
2011-03-24
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

adenovirus infection

Interventions

The induction therapy consists of CDV 3 mg/kg/day infused intravenously for 1 hr once a week for the first 3 weeks. The same dose is administered once every 2 weeks after the induction therapy as main

Sponsors

Hematology, Osaka City University, Graduate School of Meicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who had received allogeneic hematopoietic stem cell transplantation (using bone marrow, peripheral blood or cord blood as stem cell source)must be fulfilled at least one of the following. 1) Patients who were diagnosed as adenovirus infection refractory to conservative treatment 2) Patients with adenoviremia who have clinical manifestation

Exclusion criteria

Exclusion criteria: Subjects who meet any of the following criteria are not eligible. 1) Positive for anti-HIV antibody 2) Positive for hepatitis B surface antigen or HBV-DNA 3) Positive for anti-HCV antibody 4) Creatinine clearance lower than 0.1ml/min/kg calculated by the Cockcroft-Gault formula 5) Patients who have coexisting sinusoidal obstruction syndrome 6) Known hypersensitivity to cidofovir 7) Known hypersensitivity to probenecid 8) Patients who are ineligible for this study as judged by the investigator

Design outcomes

Primary

MeasureTime frame
Disappearance of signs and symptoms in association with adenovirus infection Elimination of adenovirus from the tissue specimen on which diagnosis of adenovirus infection was made.

Secondary

MeasureTime frame
Reduction of viral load Improvement of clinical symptoms, imaging findings and abnormal laboratory values in association with adenovirus infection.

Countries

Japan

Contacts

Public ContactMika Nakamae

Osaka City University, Graduate School of Medicine Hematology(Clinical research center for hematological malignancies )

crc-hematology@med.osaka-cu.ac.jp06-6645-3881

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026