2023-504414-29-00
Recruiting
Phase III and phase IV (Integrated)
Observational Study to Evaluate Efficacy, Safety and Biomarkers of Bulevirtide Treatment in Patients with Chronic hepatitis D
Karolinska University Hospital1 site in 1 country400 target enrollmentStarted: May 12, 2023Last updated:
Overview
- Phase
- Phase III and phase IV (Integrated)
- Status
- Recruiting
- Sponsor
- Karolinska University Hospital
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Percentage of patients with virological response of HDV RNA < LoD at FU 12 months after EOT.
Overview
Brief Summary
To assess the percentage of patients with virological response of HDV RNA < limit of detection (LoD) at follow-up (FU) 12 months after end of treatment (EOT).
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age > 18 years
- •Diagnosis of chronic HBV/HDV co-infection
- •Have compensated liver disease (presence of portal hypertension without ongoing hepatic decompensation, as ascites, variceal bleeding and hepatic encephalopathy, is allowed)
- •Have indication for treatment of BLV, or already treated with BLV.
- •For female participants: a. Postmenopausal for at least one year, or b. Surgically sterile (total hysterectomy or bilateral oophorectomy, bilateral tubal ligation, staples, or another type of sterilization), or c. Abstinence from heterosexual intercourse throughout the treatment period, or d. Willingness to use highly effective contraception (double barrier method or barrier contraception in combination with hormonal or intrauterine contraceptive) throughout the treatment period and for 6 months after last dose of the drugs in the study.
- •Male participants must agree to use a highly effective contraception (double barrier method or barrier contraception in combination with hormonal or intrauterine contraceptive used by female partners) throughout the treatment period and for 6 months after the last dose of the drugs in the study.
- •Participants who are willing to give written informed consent.
Exclusion Criteria
- •Any contra-indications to treatment with BLV, including any intolerance or hypersensitivity to the active ingredient or other components of BLV.
- •Pregnant or breast-feeding women
- •Patients with predictable difficulties of FU according to the investigator
- •Any other condition that, in the opinion of Investigator, precludes the patient from taking part in this study.
Outcomes
Primary Outcomes
Percentage of patients with virological response of HDV RNA < LoD at FU 12 months after EOT.
Percentage of patients with virological response of HDV RNA < LoD at FU 12 months after EOT.
Secondary Outcomes
- Percentage of patients with virological response of HDV RNA < LoD at month 1, 3 and every 3 months during treatment, and FU month 3, 6 and 9 after EOT.
- Percentage of patients with HBsAg < LoD at month 1 and 3, and every 3 months after treatment start, and FU month 3, 6, 9 and 12 after EOT.
- Change of HBsAg from baseline every 3 months during study period.
- Percentage of patients with HDV RNA < LoD or HDV RNA reduction of at least 2 log10 compared to baseline, at month 1 and 3, and every 3 months after treatment start, and FU month 3, 6, 9 and 12 after EOT.
- Percentage of patients with virological relapse, defined as HDV RNA < LoD at EOT and increase of HDV RNA to > LoD after EOT, after EOT, at FU month 3, 6, 9 and 12 after EOT.
- Percentage of patients with appearance of hepatitis B surface antibody (anti-HBs) at EOT, and FU month 3, 6, 9 and 12 after EOT.
- Percentage of patients with HBV DNA level < LoD every 3 months during study period.
- Percentage of patients with biochemical response, defined as normalization of alanine transaminase (ALT), at month 1, 3 and every 3 months during treatment, and FU month 3, 6, 9 and 12 after EOT.
- Percentage of patients with combined response, defined as HDV RNA < LoD or HDV RNA reduction of at least 2 log10 compared to baseline and ALT normalization, at month 1, 2 and 3, and every 3 months after treatment start, and FU month 3, 6, 9 and 12 after EOT.
- Change of liver elasticity measurement level from baseline compared to the level at every 6 months during on-treatment, EOT, and FU month 6 and 12 after EOT
- Percentage of AE of special interest: 1. Liver-related event, defined as new diagnoses of liver cirrhosis, HCC, or hepatic decompensation (ascites, variceal bleeding or hepatic encephalopathy); 2. Event of ≥ grade 3 hematological AE (in IFN treated); 3. Event of thyroid disorder (in IFN treated); 4. Event of injection site reaction; 5. Event of≥ grade 3 ALT increase.
- Percentage of missed BLV doses during treatment.
- Percentage of patients with early discontinuation of treatment and the reasons.
- Percentage of patients with SAE.
- EXPLORATORY ENDPOINTS: Change of HBcrAg from baseline every 3 months during study period.
- Change of HBV RNA level from baseline every 3 months during study period.
- Change of fibrosis stage in pre-treatment liver biopsy, compared to fibrosis stage in on- or post-treatment liver biopsy.
- Change of inflammation grade in pre-treatment liver biopsy, compared to inflammation grade in on- or post-treatment liver biopsy.
- Change of quality of life pre-treatment from baseline, compared to every 6 months after treatment start, EOT and FU month 6 and 12.
- Change of innate or adaptive immunological marker/signature in PBMC from baseline, compared to month 1, 6, and every 6 months, EOT, FU month 6 and 12.
- Identification of any innate or adaptive immunological marker/signature in PBMC, associated with on- or off-treatment virological and/or biochemical response.
- Identification of any intrahepatic immune marker/signature in pre-treatment liver biopsy, associated with on-treatment or off-treatment virological and/or biochemical response
- Identification of any biomarker in serum, associated with on- or off-treatment virological and/or biochemical response.
- Identification of any changes in oral or fecal microbiome, or other features in saliva or feces from baseline during and after treatment.
Investigators
SOO ALEMAN
Scientific
Karolinska University Hospital
Study Sites (1)
Loading locations...
Similar Trials
Recruiting
Phase 4
Pragmatic Randomized Trial to Evaluate the Effectiveness of High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in adults aged 65 to 79 years in Galicia, Spain2023-506977-36-00Complexo Hospitalario Universitario De Santiago114,011
Recruiting
Not Applicable
Evaluation of the Q-Pad hrHPV Test System for Identifying PrecancerNCT07281599Qurasense450
Not yet recruiting
Phase 1/2
DORAL2024-513941-35-00Centre de Recherches et d’Etudes sur les Pathologies Infectieuses, Tropicales et le VIH/Sida118
Not yet recruiting
Phase 2
Safety and Effectiveness of a 10-Day Remdesivir Treatment to Prevent Severe COVID-19 in Kidney Transplant Patients with Mild or No Symptoms: A Single-Group Trial2024-519272-96-00Fundacion Fls De Lucha Contra El Sida Las Enfermedades Infecciosas Y La Promocion De La Salud Y La C15
Active, not recruiting
Phase 1/2
KDTV001 注射液治疗子宫颈高级别鳞状上皮内病变（HSIL）的多中心、开放性 I/Ⅱ期临床研究CTR20254828144