POMALIDOMIDE for Chronic hepatitis B

Inclusion criteria

• {"criterion_text":"- Evidence of chronic HBV infection defined as positive for HBsAg for >6 months\n- Age 18-70 years\n- HBeAg positive or negative at screening\n- Not on nucleoside analogue treatment\n- Ability and willingness to provide informed consent\n- A female, may be eligible to enter and participate in the study if she: o\tIs of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy, or bilateral oophorectomy or, o\tIs of child-bearing potential with a negative pregnancy test at both screening and day 0 and agrees to use one of the following methods of contraception to avoid pregnancy: - Complete abstinence from penile-vaginal intercourse from 2 weeks prior to administration of IP, throughout the study, and for at least 2 weeks after discontinuation of all study medications - Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year \tMale partner sterilization confirmed prior to the female subject’s entry into the study, and this male is the sole partner for that subject - Approved hormonal contraception - Any other method with published data showing that the expected failure rate is <1% per year - Any contraception method must be used consistently, in accordance with the approved product label and for at least 2 weeks after discontinuation of study therapy.\n- All participants must agree not to participate in a conception process (e.g. active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization, egg donation) during the study\n- Heterosexually active male if they are: willing to use an effective method of contraception (anatomical sterility in self that is confirmed prior to study entry) or agree on the use of an effective method of contraception with an effective failure rate of < 1% by his partner (hormonal contraception, intra-uterine device (IUD), or anatomical sterility) from the day prior to the first dose and for at least 4 weeks after discontinuation of study drug."}

Exclusion criteria

• {"criterion_text":"- Participation in other clinical trials within the last 6 months\n- Regular NSAID usage (>7 days continuous use in the last month) and/or unable to avoid regular NSAID use on the trial.\n- Currently receiving other systemic immune-enhancing or immunosuppressive therapy (immunisation and locally applied agents are allowed) or having received any of those within 28 days prior to study entry\n- Current (within the previous two weeks) use of strong CYP1A2 inhibitors (including abametapir, ciprofloxacin, enoxacin, fluvoxamine and pixantrone) at enrolment.\n- Received peg- IFNα treatment within 12 months\n- History of malignancy or transplantation, excluding adequately treated basal cell carcinoma\n- Co-infection with HIV, hepatitis C or D (Individuals with prior hepatitis C infection that is now cleared are eligible for enrolment)\n- Impaired renal function with estimated creatinine clearance (eGFR) <50 mL/min\n- Significant cardiac dysfunction\n- Current or recent gastrointestinal disease or gastrointestinal surgery that may impact the absorption of the investigational drug\n- Women who are pregnant or breastfeeding or Women of Child Bearing Potential (WOCBP) who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy as specified in the inclusion criteria\n- Known allergy or hypersensitivity to pomalidomide\n- The following laboratory values at screening (lab tests may be repeated, as clinically indicated, to obtain acceptable values before failure at screening is concluded but supportive therapies are not to be administered within the week prior to screening tests): Hepatic transaminases (AST or ALT) ≥2 x upper limit of normal (ULN), eGFR <50 mL/min, Platelet count ≤100 x109/L, Absolute neutrophil count ≤1.5x109/L, Haemoglobin <10,0 g/dL, Total lymphocyte count <800 cells/mL\n- Prior or current lenalidomide, thalidomide or pomalidomide treatment or any condition where those treatments are indicated.\n- Unable or unwilling to adhere to protocol procedures\n- Active alcohol or substance use that, in the Investigator's opinion, will prevent adequate compliance with study therapy or procedures\n- Liver fibrosis or cirrhosis as determined by histological examination of a liver biopsy specimen (Metavir = or >3 or Ishak fibrosis score = or >3) or, in the absence of an appropriate liver biopsy, defined clinically with a FibroScan result >9 kPa within 6 months of screening\n- Hepatic impairment defined as ALT >2 x upper limit of normal\n- History of procoagulant disorders or venous/arterial thromboembolism\n- Currently receiving anticoagulant therapy"}

Primary endpoints

• {"endpoint_text":"- Safety defined as treatment-emerging adverse events (AEs) = or > grade 3 probably or definitely related to pomalidomide.","definition_or_measurement_approach":"Treatment-emerging adverse events graded by severity (grade) and assessed for causality as probably or definitely related to pomalidomide."}
• {"endpoint_text":"- Safety defined as all other treatment-emerging AEs, graded according to severity and assessed as either not related or possibly, probably or definitely related to pomalidomide","definition_or_measurement_approach":"All treatment-emerging adverse events graded according to severity and assessed for relationship to pomalidomide (not related, possibly, probably, or definitely related)."}

Secondary endpoints

• {"endpoint_text":"- Quantitative plasma levels of HBV DNA","definition_or_measurement_approach":"Measurement of plasma HBV DNA levels (quantitative viral load)."}
• {"endpoint_text":"- Quantitative plasma levels of HBsAg","definition_or_measurement_approach":"Quantitative measurement of hepatitis B surface antigen (HBsAg) in plasma."}
• {"endpoint_text":"- Serum titres of anti-HBs and anti-HBe","definition_or_measurement_approach":"Measurement of serum antibody titres for anti-HBs and anti-HBe."}
• {"endpoint_text":"- Levels of the liver function tests (LFTs) including ALT, bilirubin and PP","definition_or_measurement_approach":"Laboratory measurement of liver function tests including ALT, bilirubin and prothrombin/protein (PP)."}
• {"endpoint_text":"- Numbers, proportions and subset distribution of NK cells including changes in the proportion of cytotoxic and dysfunctional NK cells as determined by expression of CD56, CD16, activating and inhibitory markers using flow cytometry","definition_or_measurement_approach":"Flow cytometry assessment of NK cell numbers, proportions and subset markers (CD56, CD16, activating and inhibitory markers) to determine cytotoxic and dysfunctional NK cell populations."}
• {"endpoint_text":"- The frequency of CD4 and/or CD8 T-cell responses to HBV peptides measured either by intracellular cytokine staining (ICS), activation induced marker (AIM) assay or by ELISPOT and the proportion of polyfunctional CD8+ T cells","definition_or_measurement_approach":"Assessment of HBV-specific CD4/CD8 T-cell responses using ICS, AIM assay or ELISPOT and measurement of polyfunctional CD8+ T cell proportions."}

Methods

• Recruitment arrangements (document: K1_Recruitment arrangements_PIPPI) - general recruitment plan
• Social media (document: K2_Recruitment material_social media_DK_PIPPI) - country-specific (Denmark) social media outreach
• Flyer (document: K2_Recruitment material_Flyer) - printed recruitment materials
• E-boks (document: K2_Recruitment material_E boks_PIPPI) - Danish secure digital mail outreach
• Reminder (document: K2_Reminder PIPPI) - reminder communications to potential participants

Denmark

Earliest CTIS Part Ii Submission Date

13-05-2025

Latest Decision Or Authorization Date

12-03-2026

Processing Time Days

303

Number Of Sites

1

Number Of Participants

14

Primary sponsor

Full Name

Region Midtjylland

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Aalborg University Hospital","duties_or_roles":"code 4","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"code 1","organisation_type":"Educational Institution"}