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

ConditionChronic Hepatitis D
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKarolinska University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Bulevirtide

    Drug

    Hepcludex, 2 mg daily subcutaneous injection

Treatment groups

No treatment groups listed

Trial outcomes

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

Time frame
Continuously, up to 12 months

Secondary outcomes

1

Percentage of patients with virological response of HDV RNA < LoD

Percentage of patients with virological response of HDV RNA \< LoD at at month 1, 3 and every 3 months after treatment start, and FU month 3, 6, and 9 after EOT.

Time frame
At Baseline, 1 and 3 months, every 3 months after treatment start up to 9 months after date of EOT.
2

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

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.

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

Change of HBsAg from baseline

Change of HBsAg from baseline every 3 months during study period.

Time frame
From Baseline every 3 months until end of study.
4

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

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karolinska University Hospital

Lead sponsor

Source ClinicalTrials.gov
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