A Registry Study of Treatment With Bulevirtide in Participants With Chronic Hepatitis D Infection

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Gilead Sciences Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Trial duration

6 Feb 2023 → ongoing

Decision date (initial)

2023-01-30

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Gilead Sciences Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

To evaluate the long-term effects of bulevirtide (BLV) treatment on clinical progression of liver disease through the incidence of liver-related events in participants treated with BLV

Secondary objectives 1

1. To evaluate the development of cirrhosis in participants treated with BLV who were previously noncirrhotic To evaluate the safety of participants treated with BLV

Conditions and MedDRA coding

Chronic Hepatitis D Infection

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 1) Adult (≥ 18 years) participants who have been diagnosed with chronic hepatitis D virus (HDV) infection for at least 6 months before study enrollment, confirmed by respective documentation in the participants’ medical records. 2) Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures. 3) Must be willing and able to comply with the visit schedule and study requirements. 4) Cohort 1 only: Must have participated in study MYR-Reg-02 and have the following documented results: a) Assessment of ascites and hepatic encephalopathy within 3 months prior to start of BLV treatment b) Laboratory analytes required to calculate Child-Turcotte-Pugh (CTP) and Model for End-Stage Liver Disease (MELD) scores within 3 months prior to start of BLV treatment as follows: i) Serum bilirubin ii) Serum creatinine iii) International normalized ratio (INR) iv) Serum albumin c) Documentation of fibrosis status assessment within 6 months prior to start of BLV treatment by at least 1 of the following: i) Biopsy ii) FibroScan® d) Quantitative HDV RNA within 3 months prior to start of BLV treatment e) Alanine aminotransferase (ALT) within 3 months prior to start of BLV treatment 5) Cohort 2 only: Participants scheduled to receive BLV according to the approved label or for whom the decision to start treatment with BLV according to the approved label has been made and treatment initiation is planned

Exclusion criteria 1

1. 1) Participants currently enrolled in BLV clinical treatment studies and/or other interventional clinical studies with an investigational agent. 2) History or current presence of clinically significant illness or any other major medical disorder that may interfere with participant follow-up, assessments, or compliance with the protocol. 3) Coinfection with hepatitis C virus (HCV) or HIV (Participants with HCV antibodies can be enrolled if HCV RNA is negative) 4) Solid organ transplantation 5) Any history, or current evidence of clinical hepatic decompensation (ie, ascites, encephalopathy, jaundice, or GIB) 6) Presence of HCC as evidenced by imaging (eg, ultrasound or computed tomography scan) performed within 4 months prior to Day 1 for participants with cirrhosis and within 6 months prior to Day 1 for participants without cirrhosis 7) Individuals deemed by the study investigator to be inappropriate for study participation for any reason not otherwise listed.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Exposure-adjusted incidence of participants with liverrelated events: hepatic decompensation (ie, ascites, jaundice, hepatic encephalopathy, portal hypertensionrelated gastro-intestinal bleeding [GIB]), hepatocellular carcinoma (HCC), liver transplantation, and liver-related death through 144 weeks of BLV treatment

Secondary endpoints 1

1. Percentage of participants who develop cirrhosis during the study among participants who were previously noncirrhotic Percentage of participants with serious adverse events (SAEs), Grade 3 or 4 adverse events (AEs), and discontinuations due to AEs

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Gilead Sciences Inc.

Sponsor organisation

Gilead Sciences Inc.

Address

333 Lakeside Drive

City

Foster City

Postcode

94404-1147

Country

United States

Scientific contact point

Organisation

Gilead Sciences Inc.

Contact name

EU Clinical Trials Support

Public contact point

Organisation

Gilead Sciences Inc.

Contact name

EU Clinical Trials Support

Third parties 3

Locations

7 EU/EEA countries · 55 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 48 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

25 submissions — initial application plus substantial / non-substantial modifications