Trial information
A Study of PCR-Based Pre-Emptive Therapy With Valcyte (Valganciclovir) and Ganciclovir for Cytomegalovirus (CMV) Infection After Stem Cell Transplantation
Status: Completed
Protocol number: MX16451
Sponsor: Hoffmann-La Roche AG/Grenzach-Wyhlen
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the assessment of the pharmacokinetics of Valcyte and iv ganciclovir during preemptive therapy in patients with active CMV infection following allogeneic stem cell transplantation
Brief summary: This study will assess the pharmacokinetics, safety and efficacy of treatment with oral Valcyte and intravenous ganciclovir in patients with active CMV infection after allogeneic stem cell transplantation. The anticipated time on study treatment is < 3 months and the target sample size is less than 100 individuals.
Target sample size is 50.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Crossover; Pharmacokinetics study
Condition: Cytomegalovirus infections
Intervention type: Drug
Intervention name: valganciclovir[Valcyte]
Primary outcome: 1. PK of oral valganciclovir and valganciclovir-derived ganciclovir vs iv ganciclovir in patients suffering from CMV infection, with or without intestinal GVHD
Key secondary outcomes: 1. Efficacy: Decrease of CMV viral load and absence of CMV disease after 4 and 8 days of therapy Safety: Aes, laboratory safety tests
Inclusion criteria:
- adult patients >18 years of age;
- one positive test result by CMV MONITOR <=100 days after allogeneic bone marrow or peripheral blood stem cell transplant, or CMV-positive before transplant and/or grafted from a CMV sero-positive donor.
Exclusion criteria:
- pregnant or breastfeeding women, or men and women of childbearing potential unwilling to use adequate form of contraception during and 90 days after study completion;
- CMV invasive disease;
- other antiviral therapy.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 06/24/2005
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Germany
- Dresden
- Grenzach-Wyhlen
- Hannover
