Trial Information

Summary: 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 Design / Study Details:

  • Purpose: Treatment
  • Allocation: Non-Randomized
  • Masking: Open Label
  • Control: Uncontrolled
  • Assignment: Crossover
  • Endpoints: Pharmacokinetics

Study Type:

Interventional

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

Accepts Healthy Volunteers: No

Trial Registration Date: 06/24/2005

Date Last Updated: 09/19/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Dresden, Germany, 01067
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: October 6, 2008 at 2:56:36 PM


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