Glioblastoma MultiformePhase 2VIGAS2NCT04116411
A Clinical Trial Evaluating the Efficacy of Valganciclovir in Glioblastoma Patients
A Phase 2 study testing Valganciclovir Tablets, Temozolomide 120 mg and Radiotherapy 60 Gy in people with Glioblastoma Multiforme, run by Cecilia Soderberg-Naucler at 3 sites in 2 countries.
Trial summary
This study is a multicenter randomized double-blinded controlled phase 2 study evaluating the efficacy and safety of the anti-CMV drug valganciclovir vs placebo as add-on therapy in patients with glioblastoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- Valganciclovir Tablets, Temozolomide 120 mg and Radiotherapy 60 Gy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 4 Sep 2019to 16 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Patients aged 18 years or older
- Patients with newly diagnosed glioblastoma, IDH 1 wt, WHO grade IV
- Radical resection
- Concomitant treatment with temozolomide and radiation therapy
- MGMT promoter methylation status
- Patients with at least KPS 70 , ECOG/WHO 2
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- Patients providing written informed consent
- Patients cooperative and able to complete all the assessment procedures.
- Females of child-bearing age must have a negative pregnancy test at screening (all premenopausal women, or in case when menstrual status can not be ascertained in women under the age of 55). Female patient must agree to utilize a highly efficient birth control method throughout the study period (Pearl index <1, e.g: oral contraception with gestagens, transdermal contraceptives, implants, injectables, intrauterine devices, bilateral tubal occlusion, sexual abstinence or vasectomised partner). The birth control method must be used at least 30 days after treatment end. Pregnancy testing should be performed at monthly intervals due to high teratogenic potential of valganciclovir. Men are recommended to use condoms with female partners during, and for at least 90 days following treatment with Valganciclovir.
- Patients must be enrolled within 10 weeks after surgery
Who cannot join
- Patients allergic to, or who do not tolerate Valganciclovir, aciclovir or valaciclovir treatment
- Patients with decreased cognitive function (below 24 in MMSE test)
- Pregnant or lactating females
- Patients not signing informed consent
- Patient is simultaneously participating in another experimental drug therapy trial
- Neutrophil count < 1,5 cells/ 109/L
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- Platelet count < 150 cells/ 109/L
- HGB < 80 g/L
- Abnormal renal function (GFR < 30)
- Secondary glioblastoma, or glioblastoma IDH1 mutated.
- Unfit for any other reason judged by investigator
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Norway2 sites
Oslo University Hospital
Oslo
Stavanger University Hospital
Stavanger
Sweden1 site
SE01 Karolinska University Hospital
Solna, Stockholm County, SE17164
About this study
Official title: A Multicenter Randomized Double-blinded Controlled Phase 2 Study Evaluating the Efficacy of Valganciclovir as add-on Therapy in Glioblastoma Patients
This study is a multicenter randomized double-blinded controlled phase 2 study evaluating the efficacy and safety of the anti-CMV drug valganciclovir vs placebo as add-on therapy in patients with glioblastoma. Valganciclovir is approved for treatment of cytomegalovirus (CMV) infections, but may also have anti-tumoral effects. Current evidence imply that most glioblastomas are CMV positive and that the virus can affect tumor aggressiveness.
Read the detailed description
Adult patients will either be randomized to standard treatment (temozolomide and radiation therapy) + placebo tablets or to standard treatment + valganciclovir. Patients are randomized using 1 to 1 distribution of the patients between the treatment groups and are stratified according to methylation status of the MGMT promoter; equal proportion of patients are included in each group. A maximum of 30% of patients with methylated MGMT promoter are allowed into the study (to harmonise with current data used for statistical power calculation), as MGMT promotor methylation status is prognostic for patient survival. Patients must enter the study within 10 weeks after surgery.
Full dose treatment with 900mgs of Valganciclovir is given twice daily for 6 weeks, thereafter 900 mgs daily during 98 weeks (total treatment of 24 months). Valganciclovir is available in 450 mg tablets. The dose of Valganciclovir will be adjusted according to renal function.
This study will be performed in compliance with the protocol, ICH-GCP, the declaration of Helsinki and applicable Swedish regulatory requirements.
The study discontinuation criteria are as follows:
- Withdrawal of consent
- An adverse event which requires discontinuation of the trial medication or results in
- inability to continue to comply with trial procedures
- Disease progression which results in inability to continue to comply with trial
- procedures
- Major Protocol deviations
- Exclusion criteria met
- Conditions
- Glioblastoma Multiforme
- Being tested
- Valganciclovir Tablets, Temozolomide 120 mg, Radiotherapy 60 Gy, Placebo oral tablet
- Keywords
- cytomegalovirus, valganciclovir
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valganciclovir TabletsDrug
Also called Valcyte, ValGANcilovir, Valganciclovir 450 mg, J05AB14
Valganciclovir treatment of glioblastoma
Temozolomide 120 mgDrug
Also called Temozolomide pill, Temozolomide tablet
Chemotherapy
Radiotherapy 60 GyRadiation
Also called Radiation
Radiation therapy
Placebo oral tabletDrug
Also called Placebos
Placebo treatment of glioblastoma
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Patients will receive placebo tablets with similar appearance as the active drug. Patients receive two 450 mg tablets twice daily taken per orally for 6 weeks, thereafter two 450 mg tablet once daily for an additional 22.5 months; a total treatment time of 24 months. Receives: Drug: Temozolomide 120 mg; Radiation: Radiotherapy 60 Gy; Drug: Placebo oral tablet |
| Valganciclovir | Active comparator | Patients will receive valganciclovir tablets with similar appearance as the placebo tablets. Patients receive two 450 mg valganciclovir tablets twice daily taken per orally for 6 weeks, thereafter two 450 mg valganciclovir tablets once daily for an additional 22.5 months; a total treatment time of 24 months. Receives: Drug: Valganciclovir Tablets; Drug: Temozolomide 120 mg; Radiation: Radiotherapy 60 Gy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of valganciclovir on median overall survival of glioblastoma patients
Median overall survival will be analyzed using Cox regression analysis and presented by Kaplan-Meier graphs. Proportion of patients alive at 12 or 24 months, respectively, in each study arm and will be analyzed using Fisher exact test.
Measured: Study closure at 30 months follow up. Survival analyses will be analysed at 12 and 24 months.
Baseline and demographic data
All baseline and demographic data will be analysed using descriptive statistics such as mean, medians, standard deviations etc. for all variables which are continuous. Variables that are categorical will be analysed using frequency tables with number of patients and percent. All these analyses will be divided by treatment group. No formal hypothesis testing will be performed for the demographic and baseline variables.
Measured: At 30 months follow up
Secondary outcomes (5)
Progression free survival at 12 and 24 months
Tumor recurrence is estimated as clinical and radiological determination (RANO criteria and NANO criteria). The progression free survival will be calculated as the (date of progression - date of first dose of study drug). Patients who are alive without progression at end of follow-up will be censored. Patients who are withdrawn from the study during the follow-up for other reason than dead will be censored at time of withdrawal. Patients who dies for any reason during the follow-up without any progression will be classified as progression using date of death as date of progression. Patients are analysed for stable disease, surgical interventions and treatment failure.
Progression free survival will be analysed using Cox regression analysis and presented by Kaplan-Meier graphs. The difference in 12 and 24 months progression free survival rates for patients treated with valganciclovir or placebo will be analysed using Fisher exact test.
Measured: 12 and 24 months
Incidence of valganciclovir treatment related adverse events
Number of patients with treatment related adverse events, as assessed by CTCv4. Vital signs: blood pressure (mmHg), heart rate (beats per minute), temperature (degree Celsius), clinical laboratory (total blood counts and differential analyses, liver transaminases and bilirubin, and renal function (creatinine and GFR) and physical exam. Adverse events will be analyzed using a chi-square test without continuity correction.
Measured: 30 months follow up time
Health related Quality of Life using EORTC QLQ30 module
Quality of Life measures are recoreded according to EORTC QLQ30 and BN20 module, that are validated for brain tumor patients and measured as a unit of scale. There will be a comparison of scores for patients receiving valganciclovir versus placebo treatment. These are standard tools for assessing patients reported quality of Life along time during treatment. The change from baseline will be analysed using Wilcoxon Rank Sum test.
Measured: Base line and at every 3 months until 24 months follow up.
Cognitive functions
MMSE (Mini Mental State Examination) tests are made with a questionary form and will be assesses every three months during the study. The change from baseline will be analysed using Wilcoxon Rank Sum test.
Measured: up to 24 months
Health related Quality of Life using the EORTC BN20 module
Quality of Life measures are recoreded according to BN20 module, that are validated for brain tumor patients and measured as a unit of scale. There will be a comparison of scores for patients receiving valganciclovir versus placebo treatment. These are standard tools for assessing patients reported quality of Life along time during treatment. The change from baseline will be analysed using Wilcoxon Rank Sum test.
Measured: Base line and at every 3 months until 24 months follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start4 Sep 2019
- Primary completion16 Sep 2027 (estimated)
- Study completion16 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Glioblastoma MultiformeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multicenter randomized double-blinded controlled phase 2 study evaluating the efficacy of valganciclovir as add-on therapy in glioblastoma patients. Patients will receive either placebo or valganciclovir according to a randomisation list, blinded to the sponsor and study team. Seven centers are aimed to include patients once approval is received for each respective study center.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cecilia Soderberg-Naucler
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital, Karolinska Institutet
- Responsible party
- Sponsor-investigator, Cecilia Soderberg-Naucler, Karolinska Institutet
- Investigators
- Giuseppe Stragliotto, MD, PhD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04116411
- Sponsor's protocol ID
- Eudra CT: 2019-001083-30
- Acronym
- VIGAS2
- Status last verified
- Dec 2025
- First submitted
- 29 Aug 2019
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: When approval from authorities in Sweden allows data sharing, these will be available for other researchers.
Publications
Peredo I, Hellden A, Wolmer-Solberg N, Pohanka A, Stragliotto G, Rahbar A, Stahle L, Bellander BM, Soderberg-Naucler C. Ganciclovir concentrations in the cerebral extracellular space after valganciclovir treatment; a case study. BMJ Case Rep. 2015 Dec 15;2015:bcr2014207694. doi: 10.1136/bcr-2014-207694.
PubMed 26670887Rahbar A, Orrego A, Peredo I, Dzabic M, Wolmer-Solberg N, Straat K, Stragliotto G, Soderberg-Naucler C. Human cytomegalovirus infection levels in glioblastoma multiforme are of prognostic value for survival. J Clin Virol. 2013 May;57(1):36-42. doi: 10.1016/j.jcv.2012.12.018. Epub 2013 Feb 4.
PubMed 23391370Cobbs CS. Does valganciclovir have a role in glioblastoma therapy? Neuro Oncol. 2014 Mar;16(3):330-1. doi: 10.1093/neuonc/nou009. No abstract available.
PubMed 24523453Stragliotto G, Rahbar A, Solberg NW, Lilja A, Taher C, Orrego A, Bjurman B, Tammik C, Skarman P, Peredo I, Soderberg-Naucler C. Effects of valganciclovir as an add-on therapy in patients with cytomegalovirus-positive glioblastoma: a randomized, double-blind, hypothesis-generating study. Int J Cancer. 2013 Sep 1;133(5):1204-13. doi: 10.1002/ijc.28111. Epub 2013 Mar 13.
PubMed 23404447Soderberg-Naucler C, Peredo I, Stragliotto G. Valganciclovir in patients with glioblastoma. N Engl J Med. 2013 Nov 21;369(21):2066-7. doi: 10.1056/NEJMc1312413. No abstract available.
PubMed 24256396Merchut-Maya JM, Bartek J Jr, Bartkova J, Galanos P, Pantalone MR, Lee M, Cui HL, Shilling PJ, Brochner CB, Broholm H, Maya-Mendoza A, Soderberg-Naucler C, Bartek J. Human cytomegalovirus hijacks host stress response fueling replication stress and genome instability. Cell Death Differ. 2022 Aug;29(8):1639-1653. doi: 10.1038/s41418-022-00953-w. Epub 2022 Feb 22.
PubMed 35194187
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Double-blinded Controlled Phase 2 Study Evaluating the Efficacy of Valganciclovir as add-on Therapy in Glioblastoma Patients
- ClinicalTrials.gov ID
- NCT04116411
- Acronym / sponsor ID
- VIGAS2 / Eudra CT: 2019-001083-30
- Conditions
- Glioblastoma Multiforme
- Keywords
- cytomegalovirus, valganciclovir
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Cecilia Soderberg-NauclerUniversity, hospital or other
- Collaborators
- Karolinska University Hospital, Karolinska Institutet
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- 16 Sep 2027 (estimated)
- Study completion
- 16 Sep 2027 (estimated)
- First posted
- 4 Oct 2019 (actual)
- 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.
This study is a multicenter randomized double-blinded controlled phase 2 study evaluating the efficacy and safety of the anti-CMV drug valganciclovir vs placebo as add-on therapy in patients with glioblastoma. Valganciclovir is approved for treatment of cytomegalovirus (CMV) infections, but may also have anti-tumoral effects. Current evidence imply that most glioblastomas are CMV positive and that the virus can affect tumor aggressiveness.
Detailed description
Adult patients will either be randomized to standard treatment (temozolomide and radiation therapy) + placebo tablets or to standard treatment + valganciclovir. Patients are randomized using 1 to 1 distribution of the patients between the treatment groups and are stratified according to methylation status of the MGMT promoter; equal proportion of patients are included in each group. A maximum of 30% of patients with methylated MGMT promoter are allowed into the study (to harmonise with current data used for statistical power calculation), as MGMT promotor methylation status is prognostic for patient survival. Patients must enter the study within 10 weeks after surgery.
Full dose treatment with 900mgs of Valganciclovir is given twice daily for 6 weeks, thereafter 900 mgs daily during 98 weeks (total treatment of 24 months). Valganciclovir is available in 450 mg tablets. The dose of Valganciclovir will be adjusted according to renal function.
This study will be performed in compliance with the protocol, ICH-GCP, the declaration of Helsinki and applicable Swedish regulatory requirements.
The study discontinuation criteria are as follows:
- Withdrawal of consent
- An adverse event which requires discontinuation of the trial medication or results in
- inability to continue to comply with trial procedures
- Disease progression which results in inability to continue to comply with trial
- procedures
- Major Protocol deviations
- Exclusion criteria met
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A multicenter randomized double-blinded controlled phase 2 study evaluating the efficacy of valganciclovir as add-on therapy in glioblastoma patients. Patients will receive either placebo or valganciclovir according to a randomisation list, blinded to the sponsor and study team. Seven centers are aimed to include patients once approval is received for each respective study center.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Temozolomide 120 mg, Radiation: Radiotherapy 60 Gy, Drug: Placebo oral tabletPatients will receive placebo tablets with similar appearance as the active drug. Patients receive two 450 mg tablets twice daily taken per orally for 6 weeks, thereafter two 450 mg tablet once daily for an additional 22.5 months; a total treatment time of 24 months. |
| Valganciclovir | Active comparator | Drug: Valganciclovir Tablets, Drug: Temozolomide 120 mg, Radiation: Radiotherapy 60 GyPatients will receive valganciclovir tablets with similar appearance as the placebo tablets. Patients receive two 450 mg valganciclovir tablets twice daily taken per orally for 6 weeks, thereafter two 450 mg valganciclovir tablets once daily for an additional 22.5 months; a total treatment time of 24 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients aged 18 years or older
- Patients with newly diagnosed glioblastoma, IDH 1 wt, WHO grade IV
- Radical resection
- Concomitant treatment with temozolomide and radiation therapy
- MGMT promoter methylation status
Key exclusion criteria (11 listed)
- Patients allergic to, or who do not tolerate Valganciclovir, aciclovir or valaciclovir treatment
- Patients with decreased cognitive function (below 24 in MMSE test)
- Pregnant or lactating females
- Patients not signing informed consent
- Patient is simultaneously participating in another experimental drug therapy trial
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 |
|---|---|---|
| Valganciclovir TabletsAlso: Valcyte, ValGANcilovir, Valganciclovir 450 mg, J05AB14Valganciclovir treatment of glioblastoma | Drug | Valganciclovir |
| Temozolomide 120 mgAlso: Temozolomide pill, Temozolomide tabletChemotherapy | Drug | Placebo, Valganciclovir |
| Radiotherapy 60 GyAlso: RadiationRadiation therapy | Radiation | Placebo, Valganciclovir |
| Placebo oral tabletAlso: PlacebosPlacebo treatment of glioblastoma | Drug | Placebo |
Primary outcome
Impact of valganciclovir on median overall survival of glioblastoma patients
Time frame: Study closure at 30 months follow up. Survival analyses will be analysed at 12 and 24 months.
Median overall survival will be analyzed using Cox regression analysis and presented by Kaplan-Meier graphs. Proportion of patients alive at 12 or 24 months, respectively, in each study arm and will be analyzed using Fisher exact test.
Baseline and demographic data
Time frame: At 30 months follow up
All baseline and demographic data will be analysed using descriptive statistics such as mean, medians, standard deviations etc. for all variables which are continuous. Variables that are categorical will be analysed using frequency tables with number of patients and percent. All these analyses will be divided by treatment group. No formal hypothesis testing will be performed for the demographic and baseline variables.
5 secondary outcomes
Progression free survival at 12 and 24 months
Time frame: 12 and 24 months
Incidence of valganciclovir treatment related adverse events
Time frame: 30 months follow up time
Health related Quality of Life using EORTC QLQ30 module
Time frame: Base line and at every 3 months until 24 months follow up.
Cognitive functions
Time frame: up to 24 months
Health related Quality of Life using the EORTC BN20 module
Time frame: Base line and at every 3 months until 24 months follow up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Background: PubMed 26670887Peredo I, Hellden A, Wolmer-Solberg N, Pohanka A, Stragliotto G, Rahbar A, Stahle L, Bellander BM, Soderberg-Naucler C. Ganciclovir concentrations in the cerebral extracellular space after valganciclovir treatment; a case study. BMJ Case Rep. 2015 Dec 15;2015:bcr2014207694. doi: 10.1136/bcr-2014-207694.
- Background: PubMed 23391370Rahbar A, Orrego A, Peredo I, Dzabic M, Wolmer-Solberg N, Straat K, Stragliotto G, Soderberg-Naucler C. Human cytomegalovirus infection levels in glioblastoma multiforme are of prognostic value for survival. J Clin Virol. 2013 May;57(1):36-42. doi: 10.1016/j.jcv.2012.12.018. Epub 2013 Feb 4.
- Background: PubMed 24523453Cobbs CS. Does valganciclovir have a role in glioblastoma therapy? Neuro Oncol. 2014 Mar;16(3):330-1. doi: 10.1093/neuonc/nou009. No abstract available.
- Results publication: PubMed 23404447Stragliotto G, Rahbar A, Solberg NW, Lilja A, Taher C, Orrego A, Bjurman B, Tammik C, Skarman P, Peredo I, Soderberg-Naucler C. Effects of valganciclovir as an add-on therapy in patients with cytomegalovirus-positive glioblastoma: a randomized, double-blind, hypothesis-generating study. Int J Cancer. 2013 Sep 1;133(5):1204-13. doi: 10.1002/ijc.28111. Epub 2013 Mar 13.
- Results publication: PubMed 24256396Soderberg-Naucler C, Peredo I, Stragliotto G. Valganciclovir in patients with glioblastoma. N Engl J Med. 2013 Nov 21;369(21):2066-7. doi: 10.1056/NEJMc1312413. No abstract available.
- Derived from this study: PubMed 35194187Merchut-Maya JM, Bartek J Jr, Bartkova J, Galanos P, Pantalone MR, Lee M, Cui HL, Shilling PJ, Brochner CB, Broholm H, Maya-Mendoza A, Soderberg-Naucler C, Bartek J. Human cytomegalovirus hijacks host stress response fueling replication stress and genome instability. Cell Death Differ. 2022 Aug;29(8):1639-1653. doi: 10.1038/s41418-022-00953-w. Epub 2022 Feb 22.
- Individual participant dataSharing planned: Yes. When approval from authorities in Sweden allows data sharing, these will be available for other researchers.
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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.
Giuseppe Stragliotto, MD, PhD principal investigator
Karolinska University Hospital
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Valganciclovir Tablets, Temozolomide 120 mg and Radiotherapy 60 Gy in people with Glioblastoma Multiforme, run by Cecilia Soderberg-Naucler at 3 sites in 2 countries.
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 10 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway, Sweden. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Impact of valganciclovir on median overall survival of glioblastoma patients (time frame: Study closure at 30 months follow up. Survival analyses will be analysed at 12 and 24 months.). The study lists 2 primary outcomes in all. 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 NCT04116411, which also lists 6 linked publications.
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 22 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.