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multicenter non-randomized non-blind exploratory clinical trial of safety and efficacy of cidofovir for adenovirus infection after hematopoietic stem cell transplantation

multicenter non-randomized non-blind exploratory clinical trial of safety and efficacy of cidofovir for adenovirus infection after hematopoietic stem cell transplantation - A clinical trial of administration of cidofovir for adenovirus infection after hematopoietic stem cell transplantation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011158
Enrollment
10
Registered
2013-07-10
Start date
2013-07-08
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 after hematopoietic stem cell transplantation

Interventions

Cidofovir 1 mg/kg/day is administrated intravenously three times a week for two weeks. Intravenous hydration with normal saline and oral probenecid are required to prevent renal damage.

Sponsors

North Japan Hematology Study Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who have received hematopoietic stem cell transplantation 2. Patients with adenovirus infection 3. Patients with risk to be severe 4. Patients who agree in writing

Exclusion criteria

Exclusion criteria: 1. Allergy to drugs used in this trial 2. Serum creatinine higher than 1.5 mg/dl (In case of renal dysfunction by viral infection, higher than 2.5 mg/dl) 3. History of receiving foscarnet 4. During pregnancy, breastfeeding or potential pregnancy 5. Patients who are recognized as inadaptable for this trial

Design outcomes

Primary

MeasureTime frame
Virological response after treatment

Secondary

MeasureTime frame
1) Clinical response of adenovirus infection 2) Adverse events 3) Survival at 2 months after treatment Changes of data below from pre to post-treatment 4) Serum creatinine 5) Proteinuria, urine occult blood 6) Blood cell count 7) Venous blood gas analysis 8) Number of cytomegalovirus antigen positive cell

Countries

Japan

Contacts

Public ContactKatsuya Fujimoto

Hokkaido University Graduate School of Medicine Department of Hematology

kfujimo@med.hokudai.ac.jp011-706-7214

Outcome results

None listed

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