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A multicenter randomized double-blinded controlled phase 2 study evaluating the efficacy of valganciclovir as add-on therapy in glioblastoma patients

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504846-73-01
Acronym
Protocol number 8
Enrollment
220
Registered
2024-10-29
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblstoma WHO grade IV

Brief summary

Compare median overall survival (OS) time in patients with newly-diagnosed glioblastoma and less than 1 cm3 remaining contrast enhancing tumor postoperatively treated with and without valganciclovir as add-on to standard therapy. The primary endpoint is median OS at End of Study (EoS) when the last patient has reached 30 months. OS time is measured from time of resection until death for any reason.

Detailed description

Compare different survival and toxicity parameters in patients with newly-diagnosed glioblastoma treated with and without valganciclovir as add-on to standard therapy.

Interventions

DRUGPlacebo tablets are produced with the same appearance as the Valganciclovir tablets
DRUGwith the same content except for the active compound.
DRUGVALGANCICLOVIR

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Compare median overall survival (OS) time in patients with newly-diagnosed glioblastoma and less than 1 cm3 remaining contrast enhancing tumor postoperatively treated with and without valganciclovir as add-on to standard therapy. The primary endpoint is median OS at End of Study (EoS) when the last patient has reached 30 months. OS time is measured from time of resection until death for any reason.

Secondary

MeasureTime frame
Compare different survival and toxicity parameters in patients with newly-diagnosed glioblastoma treated with and without valganciclovir as add-on to standard therapy.

Countries

Norway, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026