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OpenTrials
Completed

NCT Number: NCT00386412

TAMOVALCIR in Allogenic Hematopoietic Progenitors Transplant

PRINCIPAL ENDPOINT To value valganciclovir efficacy in advance treatment of CMV in patients received allogenic transplant with a uniform treatment.

SECONDARY ENDPOINT To value valganciclovir security in advance treatment of CMV in in patients received allogenic transplant with a uniform treatment.

The security will be valued by the % of patients that:

Will have negative CMV Neutropenia <1000 neutrophils/mm3 or <500 neutrophils/mm3 in the first 35 days of treatment - follow-up Renal toxicity in the first 35 days of treatment - follow-up (defined by elevated creatinine >1mg/dL or twice the basal value) CMV illness during the treatment or in the next 2 months Blood Antigenemia / PCR positive in the next 2months of treatment

This dates Hill be compared with a patients control group treated with intravenous valganciclovir

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Key information

Conditions

Cytomegalovirus Infection Cytomegalovirus Infections DNA Virus Infections Herpesviridae Infections Infections Virus Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Clínico y Provincial de Barcelona, Barcelona, Spain

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About this study

Clinical trial with a drug in new conditions of use

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients > 18 years old
  • Any patients with allogenic TPH
  • Following in post-TPH with antigenemia or PCR-CMV
  • CMV in blood test detected by antigenemia or PCR before the day 180 post-TPH
  • The beginning of treatment must be Duch early as possible. Maximum in the 72 hours from the antigenemia or PCR-CMV detection
  • Be the first or second time of a CMV infection
  • Sign the informed consent
  • Pregnancy negative test in fertile age patients

Exclusion criteria

  • Patients received auto or syngenic TPH
  • Patients <50 kg weight
  • Known allergy or hypersensibility patients to valganciclovir, ganciclovir or aciclovir
  • Digestive intolerant: nauseous, vomit and or diarrhea that could difficult oral administration of valganciclovir
  • Patients that presents CMV infection or that is being evaluated for suspected CMV
  • Patients that have presented >2 CMV infection episode, before the current one
  • Severe liver disease defined by bilirubin ≥ 10mg/dL
  • Treated with: foscarnet, ganciclovir, cidofovir or another antiviral drug active to CMV, in the previous 30 days at the current episode
  • Neutrophils < 500 /µL at the beginning of valganciclovir treatment. Patients with >500 PMN/µL and < 1000/µL must start a G-CSF treatment to get neutrophils value > 1000/µL
  • Platelets < 25/mm3 even receiving transfusion
  • Clearance Creatinine < 10mL/min or dialysed patients
  • Pregnancy or lactant women
  • Other contraindication detailed in the "filling card"
  • Previous inclusión in this study at the treated group. Is allowed that a patient participate as a control case and after that receive valganciclovir treatment in after CMV episode

Treatment and study plan

Valganciclovir

Drug

900 mg/ 12 h oral, 2 weeks 900 mg/ 24 h oral, 2 weeks

Primary outcomes

  1. To value valganciclovir efficacy in advance treatment of CMV in patients received allogenic transplant with a uniform treatment.

    Time frame: 1 year

Secondary outcomes

  1. To value valganciclovir security in advance treatment of CMV in in patients received allogenic transplant with a uniform treatment.

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

PETHEMA Foundation

Other

Registry information

Official study title

Phase II, Multicentric, Prospective and Opened Clinical Trial of Advance Valganciclovir Treatment of CMV in Allogenic Hematopoietic Progenitors Transplant

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Oct 11, 2006
Registry last updated
Sep 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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