A Multinational Observational Registry Collecting Data on the Profile of Patients with Chronic Hepatitis D Virus Infection Receiving Treatment with Bulevirtide (MYR-Reg-02)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Non-interventional observational study, no test for formal hypothesis

Study drug and medical condition

• Name of medicine:
  Hepcludex
• Anatomical Therapeutic Chemical (ATC) code:
  (J05AX28) bulevirtide
• Medical condition to be studied:
  Hepatitis D

  Liver disorder
• Additional medical condition(s):
  Adult participants who have been diagnosed with chronic HDV infection by HDV RNA,positive plasma (or serum) and compensated liver disease, confirmed by respective,documentation in the participant’s medical records.

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  100

Study design details

• Main study objective:
  Rate of liver-related clinical events in participants receiving BLV treatment: cirrhosis development, hepatic decompensation, jaundice, hepatocellular carcinoma (HCC) development, liver transplantation, and liver-related death.
• Data analysis plan:
  Continuous variables were summarized in terms of descriptive statistics including number of observations, mean, standard deviation, minimum, maximum and quartiles. Categorical variables were summarized in terms of frequencies and percentages. To account for the different durations of observation, the incidences of events were normalised to participant exposure to evaluate the incidence according to time of exposure (patient-years). An appropriate time window pattern relative to baseline (enrolment) was defined for the Registry data (e.g. months or quarters). Longitudinal data were summarized by time window. When more than one measurement for a participant falls into the same time window the last measurement was used. Summaries were provided by country and relevant concomitant treatment cohort.

Documents

Study report

Final Synoptic Clinical Study Report MYR-REG-02