Cytomegalovirus InfectionPhase 4NCT00730769
Valganciclovir for Treatment of Cytomegalovirus Infection in Solid Organ Transplant Patients
A Phase 4 study testing Single arm (ganciclovir and valganciclovir) in people with Cytomegalovirus Infection, run by Salvador Gil-Vernet at 1 site in Spain.
Trial summary
The objectives of this study were: 1. To demonstrate the efficacy/safety of a short therapeutic strategy of treatment of CMV infection/disease in SOT patients (kidney, liver and heart recipients) based on 21 days of treatment. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytomegalovirus Infection
- What is being tested?
- Single arm (ganciclovir and valganciclovir)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2004to Jul 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age, solid organ transplant recipients.
- presented a CMV infection demonstrated by CMV antigenemia (pp65) defined as ≥ 20positive cells/105 peripherical blood mononuclear cells (PBMC).
- gave written informed consent.
Who cannot join
- HIV patients.
- Multiorganic transplant.
- Severe CMV tissue invasive disease.
- Unable to receive oral medication.
- absolute neutrophil counts less than 500/ mm3.
- Platelets <25000 platelets/mm3.
- Hemoglobin< 80g/l.
- Estimated glomerular filtration rate< 10 mL/min (according to the Cockcroft-Gault formula)
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitari Bellvitge- Transplant Departments (Liver, Heart and Kidney)
L'Hospitalet de Llobregat, Barcelone, 08907
About this study
Official title: Phase IV.II Pilot Study of Treatment of Cytomegalovirus Infection With a Brief Induction With Ganciclovir i.v. Followed by Valganciclovir Oral in Solid Organ Transplant Patients.
The objectives of this study were:
- To demonstrate the efficacy/safety of a short therapeutic strategy of treatment of CMV infection/disease in SOT patients (kidney, liver and heart recipients) based on 21 days of treatment.
- To compare the exposure to ganciclovir, at steady state, after oral valganciclovir with respect to ganciclovir given intravenously (i.v.).
- Evaluate the security of this treatment with valganciclovir.
Read the detailed description
SOT recipients (kidney, liver and heart transplant) presenting CMV infection or disease were eligible for inclusion if they were ≥18 years of age and presented a positive CMV antigenemia (pp65) defined as ≥ 20positive cells/105 peripherical blood mononuclear cells (PBMC). Patients excluded were those with severe CMV tissue invasive disease, unable to receive oral medication, absolute neutrophil counts less than 500/ mm3, platelets <25000 platelets/mm3, Hemoglobin< 80g/l or estimated glomerular filtration rate< 10 mL/min (according to the Cockcroft-Gault formula).
Patients received a short induction treatment with ganciclovir i.v (Cymevene®; F. Hoffmann-La Roche Ltd, Basel, Switzerland) at the dose of 5 mg/kg/12h, by a peripherical vein infusion of one hour, during 5 days followed by treatment with oral valganciclovir (Valcyte®; F. Hoffmann-La Roche Ltd, Basel, Switzerland) at 900 mg/12h during 16 days, after meals, until complete a total of 21 days of treatment. In patients with impaired renal function ganciclovir i.v. and oral valganciclovir doses were adjusted at each visit according to estimated Glomerular Filtration Rate (GFR) by Cockcroft-Gault equation, as recommended by the manufacturer.
- Conditions
- Cytomegalovirus Infection
- Being tested
- Single arm (ganciclovir and valganciclovir)
- Keywords
- Valganciclovir, Ganciclovir, Pharmacokinetics, Solid organ transplantation, Transplant
- Medical subject headings
- Cytomegalovirus Infections, Multiple Acyl Coenzyme A Dehydrogenase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single arm (ganciclovir and valganciclovir)Drug
Also called Ganciclovir (Cymevene®), Valganciclovir (Valcyte®)
Patients received a short induction of IV ganciclovir at 5 mg/kg bid for 5 days (1 hour infusion) , followed by treatment with oral valganciclovir at 900 mg bid (after meals) for 16 days up to complet 21 days of treatment. In patients with impaired renal function, IV ganciclovir and oral valganciclovir doses were adjusted at each visit according to estimated GFR (Cockroft-Gault equation)
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Patients received a short induction of IV ganciclovir (Cymevene®; F. Hoffmann-La Roche Ltd, Basel, Switzerland) at 5 mg/kg bid for 5 days (1 hour infusion) , followed by treatment with oral valganciclovir (Valcyte®; F. Hoffmann-La Roche Ltd, Basel, Switzerland) at 900 mg bid (after meals) for 16 days up to complete 21 days of treatment. In patients with impaired renal function, IV ganciclovir and oral valganciclovir doses were adjusted at each visit according to estimated GFR (Cockcroft-Gault equation) Receives: Drug: Single arm (ganciclovir and valganciclovir) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dissapeareance of CMV (pp65) antigenemia, determined in peripheral blood mononuclear cells (PBMC).
Measured: Baseline, day 5, 10, 15, 21 of treatment and day 30, 60 and 90 of follow-up.
Secondary outcomes (2)
Dissapareance of Cytomegalovirus viremia measured by PCR, determined in plasma samples.
Measured: Basal, day 5, 10, 15 and 21 of treatment and 30, 60 and 90 of treatment.
Area under the curve (AUC) of Ganciclovir after ganciclovir i.v. and valganciclovir oral in steady state.
Measured: Day 5 (ganciclovir i.v) and day 15 (valganciclovir oral)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startMar 2004
- Primary completionJul 2007
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cytomegalovirus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Salvador Gil-Vernet
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor-investigator, Salvador Gil-Vernet, Hospital Universitari de Bellvitge
- Investigators
- Salvador - Gil-Vernet, Medicine, Study chair, Nephrology Department. Hospital Universitari of Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730769
- Sponsor's protocol ID
- VALGAN-03
- Status last verified
- Sep 2011
- First submitted
- 5 Aug 2008
- Last updated
- 21 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Caldes A, Colom H, Armendariz Y, Garrido MJ, Troconiz IF, Gil-Vernet S, Lloberas N, Pou L, Peraire C, Grinyo JM. Population pharmacokinetics of ganciclovir after intravenous ganciclovir and oral valganciclovir administration in solid organ transplant patients infected with cytomegalovirus. Antimicrob Agents Chemother. 2009 Nov;53(11):4816-24. doi: 10.1128/AAC.00085-09. Epub 2009 Sep 8.
PubMed 19738014
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV.II Pilot Study of Treatment of Cytomegalovirus Infection With a Brief Induction With Ganciclovir i.v. Followed by Valganciclovir Oral in Solid Organ Transplant Patients.
- ClinicalTrials.gov ID
- NCT00730769
- Acronym / sponsor ID
- VALGAN-03
- Conditions
- Cytomegalovirus Infection
- Keywords
- Valganciclovir, Ganciclovir, Pharmacokinetics, Solid organ transplantation, Transplant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Salvador Gil-VernetUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Mar 2004
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 8 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study were:
- To demonstrate the efficacy/safety of a short therapeutic strategy of treatment of CMV infection/disease in SOT patients (kidney, liver and heart recipients) based on 21 days of treatment.
- To compare the exposure to ganciclovir, at steady state, after oral valganciclovir with respect to ganciclovir given intravenously (i.v.).
- Evaluate the security of this treatment with valganciclovir.
Detailed description
SOT recipients (kidney, liver and heart transplant) presenting CMV infection or disease were eligible for inclusion if they were ≥18 years of age and presented a positive CMV antigenemia (pp65) defined as ≥ 20positive cells/105 peripherical blood mononuclear cells (PBMC). Patients excluded were those with severe CMV tissue invasive disease, unable to receive oral medication, absolute neutrophil counts less than 500/ mm3, platelets <25000 platelets/mm3, Hemoglobin< 80g/l or estimated glomerular filtration rate< 10 mL/min (according to the Cockcroft-Gault formula).
Patients received a short induction treatment with ganciclovir i.v (Cymevene®; F. Hoffmann-La Roche Ltd, Basel, Switzerland) at the dose of 5 mg/kg/12h, by a peripherical vein infusion of one hour, during 5 days followed by treatment with oral valganciclovir (Valcyte®; F. Hoffmann-La Roche Ltd, Basel, Switzerland) at 900 mg/12h during 16 days, after meals, until complete a total of 21 days of treatment. In patients with impaired renal function ganciclovir i.v. and oral valganciclovir doses were adjusted at each visit according to estimated Glomerular Filtration Rate (GFR) by Cockcroft-Gault equation, as recommended by the manufacturer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Drug: Single arm (ganciclovir and valganciclovir)Patients received a short induction of IV ganciclovir (Cymevene®; F. Hoffmann-La Roche Ltd, Basel, Switzerland) at 5 mg/kg bid for 5 days (1 hour infusion) , followed by treatment with oral valganciclovir (Valcyte®; F. Hoffmann-La Roche Ltd, Basel, Switzerland) at 900 mg bid (after meals) for 16 days up to complete 21 days of treatment. In patients with impaired renal function, IV ganciclovir and oral valganciclovir doses were adjusted at each visit according to estimated GFR (Cockcroft-Gault equation) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥18 years of age, solid organ transplant recipients.
- presented a CMV infection demonstrated by CMV antigenemia (pp65) defined as ≥ 20positive cells/105 peripherical blood mononuclear cells (PBMC).
- gave written informed consent.
Key exclusion criteria (8 listed)
- HIV patients.
- Multiorganic transplant.
- Severe CMV tissue invasive disease.
- Unable to receive oral medication.
- absolute neutrophil counts less than 500/ mm3.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single arm (ganciclovir and valganciclovir)Also: Ganciclovir (Cymevene®), Valganciclovir (Valcyte®)Patients received a short induction of IV ganciclovir at 5 mg/kg bid for 5 days (1 hour infusion) , followed by treatment with oral valganciclovir at 900 mg bid (after meals) for 16 days up to complet 21 days of treatment. In patients with impaired renal function, IV ganciclovir and oral valganciclovir doses were adjusted at each visit according to estimated GFR (Cockroft-Gault equation) | Drug | Single arm |
Primary outcome
Dissapeareance of CMV (pp65) antigenemia, determined in peripheral blood mononuclear cells (PBMC).
Time frame: Baseline, day 5, 10, 15, 21 of treatment and day 30, 60 and 90 of follow-up.
2 secondary outcomes
Dissapareance of Cytomegalovirus viremia measured by PCR, determined in plasma samples.
Time frame: Basal, day 5, 10, 15 and 21 of treatment and 30, 60 and 90 of treatment.
Area under the curve (AUC) of Ganciclovir after ganciclovir i.v. and valganciclovir oral in steady state.
Time frame: Day 5 (ganciclovir i.v) and day 15 (valganciclovir oral)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2011.
- Derived from this study: PubMed 19738014Caldes A, Colom H, Armendariz Y, Garrido MJ, Troconiz IF, Gil-Vernet S, Lloberas N, Pou L, Peraire C, Grinyo JM. Population pharmacokinetics of ganciclovir after intravenous ganciclovir and oral valganciclovir administration in solid organ transplant patients infected with cytomegalovirus. Antimicrob Agents Chemother. 2009 Nov;53(11):4816-24. doi: 10.1128/AAC.00085-09. Epub 2009 Sep 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salvador - Gil-Vernet, Medicine study chair
Nephrology Department. Hospital Universitari of Bellvitge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Single arm (ganciclovir and valganciclovir) in people with Cytomegalovirus Infection, run by Salvador Gil-Vernet at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dissapeareance of CMV (pp65) antigenemia, determined in peripheral blood mononuclear cells (PBMC). (time frame: Baseline, day 5, 10, 15, 21 of treatment and day 30, 60 and 90 of follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00730769, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2011.