HeberNasvac in chronic hepatitis B viral infection in adult patients. Routine clinical practice study

Evaluation of adherence, effectiveness, quality of life, and safety in patients with chronic HBV infection treated with HeberNasvac®. Routine clinical practice study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000469

Enrollment

500

Registered

2025-12-23

Start date

2026-01-12

Completion date

Unknown

Last updated

2026-08-10

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

Conditions

Chronic Hepatitis B virus infection

Interventions

HeberNasVac Group (experimental): Two treatment cycles will be administered according to the therapeutic vaccine’s product leaflet. In the first cycle, a 1.0 mL dose of HeberNasvac® intranasal per dis

Eligibility

Sex/Gender

All

Age

19 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with chronic hepatitis B (defined as being HBsAg seropositive for a minimum of 6 months), of either sex, and aged =19 years. 2. Patients who express their willingness to participate in the research by signing an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with clinical evidence or suspicion of hepatocellular carcinoma and/or liver cirrhosis based on ultrasound and elastography (=18kPa). 2. Patients with a history of decompensated liver or kidney transplants, or who are receiving hemodialysis treatment. 3. Patients with chronic autoimmune and oncohematological diseases. 4. Patients with fever, acute illnesses, or decompensated chronic illnesses. 5. Patients with ALAT or ASAT enzyme levels above 500 IU/L. 6. Patients being treated with another investigational product. 7. Patients with acute allergic conditions or a history of severe allergic reactions, or with a known hypersensitivity to any component of the vaccine. 8. Pregnant patients. 9. Patients with mental and/or psychiatric disorders that make it difficult to collect information, their treatment, or follow up their progress.

Design outcomes

Primary

Measure	Time frame
1. Treatment adherence (Good adherence: 80% or more of administrations, Fair adherence: Between 60% and 70% of administrations, Poor adherence: 50% or less administrations). Measurement time: At the end of treatment. 2. Percentage of HBsAg loss or reduction (Percentage of patients with HBsAg loss or reduction. Values will be recorded according to the established unit (IU/ml)). Measurement time: At baseline, at six months, at one year, and annually for up to 5 years.	—

Measure

Time frame

1. Treatment adherence (Good adherence: 80% or more of administrations, Fair adherence: Between 60% and 70% of administrations, Poor adherence: 50% or less administrations). Measurement time: At the end of treatment. 2. Percentage of HBsAg loss or reduction (Percentage of patients with HBsAg loss or reduction. Values will be recorded according to the established unit (IU/ml)). Measurement time: At baseline, at six months, at one year, and annually for up to 5 years.

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Secondary

Measure	Time frame
1. Quality of Life (Chronic Liver Disease Questionnaire, CLDQ). Measurement time: At baseline and, one year after. 2. Percentage of patients with HBV DNA below the limit of detection (Values will be recorded according to the established unit (IU/mL)). Measurement time points: At baseline, at six months, at one year, and annually up to five years. 3. Percentage of HBeAg and/or HBsAg loss and/or seroconversion (HBeAg: Positive or negative (dichotomous response); anti-HBeAg: Positive or negative (dichotomous response); anti-HBs: Positive or negative (dichotomous response)). Measurement time: At baseline, at six months, at one year, and annually up to five years. 4. Mean Logarithmic Reduction of HBV DNA (Values will be recorded according to the established unit (IU/mL)). Measurement time: At baseline, at six months, at one year, and annually up to five years. 5. Biochemical response defined by sustained normalization of ALT (Values will be recorded using the established unit (U/L), categorized as: normal, abnormal not clinically significant, abnormal clinically significant, and not performed, according to the defined normal reference ranges). Measurement time: At baseline, at six months, at one year, and annually up to five years. 6. Response to liver fibrosis (APRI (Relationship between ASAT levels and platelet count) and FIB-4 (Calculated from age, platelet count and ASAT and ALAT levels) indices; Transient elastography (Fibroscan). Results are reported in kPa. The degree of fibrosis will be determined from F0 to F4, taking into account the results obtained by each of the methods evaluated. F4 being the exclusion criterion for the inclusion of the patient in the study). Measurement time: At baseline, at six months, at one year, and annually up to five years. 7. Adverse Events –AE (Adverse events occurring during the study will be recorded, including those related to findings from the physical examination. It will measure: Occurrence of any AE(yes/no); Description of	—

Measure

Time frame

1. Quality of Life (Chronic Liver Disease Questionnaire, CLDQ). Measurement time: At baseline and, one year after. 2. Percentage of patients with HBV DNA below the limit of detection (Values will be recorded according to the established unit (IU/mL)). Measurement time points: At baseline, at six months, at one year, and annually up to five years. 3. Percentage of HBeAg and/or HBsAg loss and/or seroconversion (HBeAg: Positive or negative (dichotomous response); anti-HBeAg: Positive or negative (dichotomous response); anti-HBs: Positive or negative (dichotomous response)). Measurement time: At baseline, at six months, at one year, and annually up to five years. 4. Mean Logarithmic Reduction of HBV DNA (Values will be recorded according to the established unit (IU/mL)). Measurement time: At baseline, at six months, at one year, and annually up to five years. 5. Biochemical response defined by sustained normalization of ALT (Values will be recorded using the established unit (U/L), categorized as: normal, abnormal not clinically significant, abnormal clinically significant, and not performed, according to the defined normal reference ranges). Measurement time: At baseline, at six months, at one year, and annually up to five years. 6. Response to liver fibrosis (APRI (Relationship between ASAT levels and platelet count) and FIB-4 (Calculated from age, platelet count and ASAT and ALAT levels) indices; Transient elastography (Fibroscan). Results are reported in kPa. The degree of fibrosis will be determined from F0 to F4, taking into account the results obtained by each of the methods evaluated. F4 being the exclusion criterion for the inclusion of the patient in the study). Measurement time: At baseline, at six months, at one year, and annually up to five years. 7. Adverse Events –AE (Adverse events occurring during the study will be recorded, including those related to findings from the physical examination. It will measure: Occurrence of any AE(yes/no); Description of

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Countries

Cuba

Contacts

Public ContactMaria Marrero Miragaya

National Coordinating Center for Clinical Trials (Cencec)

acelia@cencec.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 25, 2026