Study to Evaluate Efficacy, Safety and Biomarkers of Bulevirtide Treatment in Chronic Hepatitis D Patients

NCT06051045 | Recruiting

• 1 other identifier: SEE-D
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The aim is to assess the efficacy and specific safety in an observational study of patients with Chronic hepatitis D (CHD) with prospective follow-up, with antiviral treatment of 2 mg Bulevirtide (BLV) +/- PEG-IFNα-2a and +/- NA given as part of the patient's routine medical care. Also, explorative endpoints of biomarkers in peripheral blood, saliva, fecal sample and/or intrahepatic markers/signatures, and quality of life outcomes will be assessed.

Conditions

Chronic Hepatitis D

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with virological response of Hepatitis D virus (HDV) RNA < Limit of Detection (LoD) at FU 12 months after End of Treatment (EOT).

  Measurement of virological response of HDV RNA \< LoD

  Continuously, up to 12 months

Secondary Outcomes (13)

• Percentage of patients with virological response of HDV RNA < LoD

  At Baseline, 1 and 3 months, every 3 months after treatment start up to 9 months after date of EOT.

• Percentage of patients with Hepatitis B surface antigen (HBsAg) < LoD

  At Baseline, 1 and 3 months, every 3 months after treatment start up to 12 months after date of EOT.

• Change of HBsAg from baseline

  From Baseline every 3 months until end of study.

• Percentage of patients with HDV RNA < LoD or HDV RNA reduction of at least 2 log10 compared to baseline

  At Baseline, 1 and 3 months, every 3 months after treatment start up to 12 months after date of EOT.

• Percentage of patients with virological relapse, defined as HDV RNA < LoD at EOT and increase of HDV RNA to > LoD after EOT

  At 0, 3, 6, 9 and 12 months after date of EOT.

Interventions

Bulevirtide DRUG

Hepcludex, 2 mg daily subcutaneous injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Males and females from the age of 18 diagnosed with chronic hepatitis D

You may qualify if:

• 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 allowed).
• Have indication for treatment of BLV, or already treated with BLV.
• For female\* participants:
• Postmenopausal for at least one year, or
• Surgically sterile (total hysterectomy or bilateral oophorectomy, bilateral tubal ligation, staples, or another type of sterilization), or
• Abstinence from heterosexual intercourse throughout the treatment period, or
• 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 last dose of the drugs in the study.
• Participants who are willing to give written informed consent

You may not qualify if:

• 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 follow-up according to the investigator.
• Any other condition that, in the opinion of Investigator, precludes the patient from taking part in this study.

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Karolinska University Hospital, Department of Infectious Diseases

Stockholm, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Biological sampling of blood, saliva and fecal samples and liver tissue (liver biopsy or fine needle aspiration

MeSH Terms

Conditions

Hepatitis D, Chronic

Interventions

bulevirtide

Condition Hierarchy (Ancestors)

Hepatitis D; Hepatitis, Viral, Human; Virus Diseases; Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Soo Aleman, MD, PhD

CONTACT

+46 72-595 72 25; soo.aleman@regionstockholm.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 22, 2023
• Study Start: September 27, 2023
• Primary Completion (Estimated): March 1, 2033
• Study Completion (Estimated): March 1, 2033
• Last Updated: September 29, 2023

Record last verified: 2023-09

Locations

SE (1)