CLINICAL TRIAL WITH PROPHYLACTIC TENOFOVIR FOR HAEMATOLOGICAL CANCER PATIENTS SHOWING A HBc-Ab POSITIVE AND HBs-Ag PATTERN AND TO BE TREATED WITH RITUXIMAB (PREBLIN STUDY)

CLINICAL TRIAL WITH PROPHYLACTIC TENOFOVIR FOR HAEMATOLOGICAL CANCER PATIENTS SHOWING A HBc-Ab POSITIVE AND HBs-Ag PATTERN AND TO BE TREATED WITH RITUXIMAB (PREBLIN STUDY) - PREBLIN

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000905-30-ES

Enrollment

Registered

2012-01-24

Start date

2011-07-08

Completion date

Unknown

Last updated

2021-12-06

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

Conditions

CHRONIC HEPATITIS B MedDRA version: 14.1 Level: LLT Classification code 10008910 Term: Chronic hepatitis B System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: VIREAD Product Name: VIREAD Product Code: J05AF07 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: TENOFOVIR DISOPROXIL FUMARATO Concentration unit: mg milligram(s) Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Male and female patients over 18 years of age •Patients diagnosed with haematological cancer scheduled to receive treatment with rituximab alone or in combination with other chemotherapy •Evidence of previous exposure to HBV: HBcAb-positive patients •HBsAg negative patients •Signed Informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 95 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3

Exclusion criteria

Exclusion criteria: • Intolerance to any treatment component. • Co-infection with HIV. • Presence of hepatocellular carcinoma • Patients with severe or moderate renal failure • Liver or kidney transplant or severe renal, lung or neurological diseases that under investigator criteria may interfere in the patient’s participation during the clinical trial. • Pregnancy or breastfeeding. • Treatment within the last 30 days with any experimental (non-authorised) drug. • Any other disease or condition that might render the patient ineligible for the trial.

Design outcomes

Primary

Measure	Time frame
Main Objective: • To compare in HBcAb- positive and HBsAg-negative haematological cancer patients, the prophylactic use of TDF versus observation assessed as the percentage of patients who experienced HBV reactivation (seroreversion or reappearance of the HBsAg) in plasma and/or an increase of HBV DNA levels = 1 log10 IU/mL compared with the baseline value during the 18 months after the starting of treatment with rituximab;Secondary Objective: •To asses the proportions of patients in each treatment group that experience reactivation of the VHB during the trial. Patients were considered to experience reactivation of the VHB when they satisfied at least on e of the following criteria: Seroreversion: reappearance of the surface antigen (HBsAg) in plasma An elevation of HBV DNA levels = 10-fold compared with the baseline value •To asses the incidence of hepatitis and liver failure or decompensation •To asses overall survival of patients •To asses the proportion of patients that discontinued the trial due to adverse clinical reactions or laboratory abnormalities related to TDF.;Primary end point(s): • Proportion of patients that experience a reactivation of HBV after 18 months of treatment with rituximab. Patients were considered to experience reactivation of the VHB when they satisfied at least on e of the following criteria: - Seroreversion: reappearance of the surface antigen (HBsAg) in plasma - An elevation of HBV DNA levels = 10 log10 IU/mL compared with the baseline value *Viral load will be determined preferably through ADN-VHB COBAS Ampliprep Taqman HBV. Hospitals without access to this technique will use the quantification methods ordinarily used in their hospital in clinical practice: COBAS-Amplicor HBV Monitor Test; Roche Diagnostics, PCR assay (LightCycler – FastStart DNA Master, Roche Diagnostic, Mannheim, Germany) or any other;Timepoint(s) of evaluation of this end point: • After 18 months of treatment with rituximab	—

Measure

Time frame

Main Objective: • To compare in HBcAb- positive and HBsAg-negative haematological cancer patients, the prophylactic use of TDF versus observation assessed as the percentage of patients who experienced HBV reactivation (seroreversion or reappearance of the HBsAg) in plasma and/or an increase of HBV DNA levels = 1 log10 IU/mL compared with the baseline value during the 18 months after the starting of treatment with rituximab;Secondary Objective: •To asses the proportions of patients in each treatment group that experience reactivation of the VHB during the trial. Patients were considered to experience reactivation of the VHB when they satisfied at least on e of the following criteria: Seroreversion: reappearance of the surface antigen (HBsAg) in plasma An elevation of HBV DNA levels = 10-fold compared with the baseline value •To asses the incidence of hepatitis and liver failure or decompensation •To asses overall survival of patients •To asses the proportion of patients that discontinued the trial due to adverse clinical reactions or laboratory abnormalities related to TDF.;Primary end point(s): • Proportion of patients that experience a reactivation of HBV after 18 months of treatment with rituximab. Patients were considered to experience reactivation of the VHB when they satisfied at least on e of the following criteria: - Seroreversion: reappearance of the surface antigen (HBsAg) in plasma - An elevation of HBV DNA levels = 10 log10 IU/mL compared with the baseline value *Viral load will be determined preferably through ADN-VHB COBAS Ampliprep Taqman HBV. Hospitals without access to this technique will use the quantification methods ordinarily used in their hospital in clinical practice: COBAS-Amplicor HBV Monitor Test; Roche Diagnostics, PCR assay (LightCycler – FastStart DNA Master, Roche Diagnostic, Mannheim, Germany) or any other;Timepoint(s) of evaluation of this end point: • After 18 months of treatment with rituximab

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Secondary

Measure	Time frame
Secondary end point(s): •Proportion of patients in the three groups of treatment that have experienced a HBV reactivation during the clinical trial. Patients were considered to experience reactivation of the VHB when they satisfied at least one of the following criteria: - Seroreversion: reappearance of the surface antigen (HBsAg) in plasma - An elevation of HBV DNA levels = 10 log10 IU/mL compared with the baseline value • Incidence of hepatitis and liver failure or decompensation • HBsAg titers in the different treatment groups (when available) • Overall patient-survival • Safety evaluation (adverse reaction and renal function parameters) in the different treatment groups.;Timepoint(s) of evaluation of this end point: • After 2,4,6,8,10,12,14 y 16 months of treatment with rituximab • After 18 months of treatment with rituximab • After 18 months of treatment with rituximab • After 18 months of treatment with rituximab • After 18 months of treatment with rituximab	—

Measure

Time frame

Secondary end point(s): •Proportion of patients in the three groups of treatment that have experienced a HBV reactivation during the clinical trial. Patients were considered to experience reactivation of the VHB when they satisfied at least one of the following criteria: - Seroreversion: reappearance of the surface antigen (HBsAg) in plasma - An elevation of HBV DNA levels = 10 log10 IU/mL compared with the baseline value • Incidence of hepatitis and liver failure or decompensation • HBsAg titers in the different treatment groups (when available) • Overall patient-survival • Safety evaluation (adverse reaction and renal function parameters) in the different treatment groups.;Timepoint(s) of evaluation of this end point: • After 2,4,6,8,10,12,14 y 16 months of treatment with rituximab • After 18 months of treatment with rituximab • After 18 months of treatment with rituximab • After 18 months of treatment with rituximab • After 18 months of treatment with rituximab

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Countries

Spain

Contacts

Public ContactPORIB

Pharmacoeconomics & Outcomes Research Iberia

MA_casado@porib.com34917159147

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026