Randomized study of oral ganciclovir versus i.v. ganciclovir for preemptive therapy of cytomegalovirus infection after stem cell transplantation.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-020551-31-FI

Enrollment

168

Registered

2010-05-04

Start date

2004-09-29

Completion date

Unknown

Last updated

2012-04-24

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

Conditions

First cytomegalovirus DNAemia after stem cell transplantation MedDRA version: 12.1 Level: LLT Classification code 10063310 Term: Cytomegalovirus DNA test positive

Interventions

Trade Name: Valcyte Product Name: Valcyte Pharmaceutical Form: Coated tablet INN or Proposed INN: VALGANCICLOVIR HYDROCHLORIDE CAS Number: 175865-59-5 Trade Name: Cymevene Product Name: Cymevene Phar

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Allogeneic SCT recipients > 50 kg of body weight, adults and children > 12 years of age Donor: sibling or an unrelated donor Conditioning: myeloablative and reduced intensity First CMV DNAemia after SCT Patients give their informed consent. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: B-neutrophils < 1x109/L. Patient unable to take oral medication Acute intestinal GVHD or ongoing grade III-IV liver GVHD Patients with leukaemia in relapse

Design outcomes

Primary

Measure	Time frame
Main Objective: to demonstrate that the treatment result with oral valganciclovir is not inferior to that obtained with iv ganciclovir in the tretament of CMV DNAemia after stem cell transplantation;Secondary Objective: As secondary endpoints CMV disease, cytopenias, acute graft-versus-host disease, atransplant related mortality, and death of any cause are analyzed.;Primary end point(s): Achievement of CMV PCR negativity during preemptive treatment of the first CMV DNAemia of the SCT recipients on day 28 or earlier in the two treatment arms.	—

Measure

Time frame

Main Objective: to demonstrate that the treatment result with oral valganciclovir is not inferior to that obtained with iv ganciclovir in the tretament of CMV DNAemia after stem cell transplantation;Secondary Objective: As secondary endpoints CMV disease, cytopenias, acute graft-versus-host disease, atransplant related mortality, and death of any cause are analyzed.;Primary end point(s): Achievement of CMV PCR negativity during preemptive treatment of the first CMV DNAemia of the SCT recipients on day 28 or earlier in the two treatment arms.

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Countries

Finland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026