- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04166266
Observatory of Efficacy and Safety of Bulevirtide in Patients With Chronic HBV/HDV Co-infection (BuleDelta)
Observatory of Efficacy and Safety of Bulevirtide in Patients With Chronic Hepatitis B Virus (HBV)/Hepatitis D Virus (HDV) Co-infection With Severe Fibrosis Injuries, or Moderate Fibrosis Injuries Associated With Persistent Increase of ALT
Study Overview
Status
Conditions
Detailed Description
Chronic hepatitis delta represents the most severe form of chronic viral hepatitis.The current treatment of hepatitis delta virus (HDV) infection consists in the use of interferon and is largely unsatisfactory. Bulevirtide is an entry inhibitor which has demonstrated significant virologic and biochemical activity in patients with HDV infection in clinical trials.
The ANRS HDEP01 BuleDelta study is an observational cohort, embedded in the french bulevirtide ATU program.
After their inclusion, patients will be followed according to the ATU protocol during treatment within the cohort ATU and according to the usual recommendations during treatment within the nominative ATU (if needed) and after the end of bulevirtide treatment. The patients included will be followed during 48 weeks after the end of their treatment.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: COULIBALY Fatoumata
- Phone Number: +331 44 23 61 10
- Email: fatoumata.coulibaly@anrs.fr
Study Contact Backup
- Name: Claire FOUGEROU-LEURENT
- Email: claire.fougerou@chu-rennes.fr
Study Locations
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Angers, France
- Recruiting
- CHU of Angers
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Principal Investigator:
- Isabelle FOUCHARD
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Clichy, France
- Recruiting
- Beaujon hospital
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Principal Investigator:
- Tarik Asselah
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Lyon, France
- Recruiting
- Hopital de la Croix Rousse
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Principal Investigator:
- Fabien Zoulim
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Lyon, France
- Recruiting
- Croix Rousse Hospital
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Principal Investigator:
- Dulce ALFAIATE
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Nantes, France
- Recruiting
- Hôtel-Dieu Hospital
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Principal Investigator:
- François RAFFI
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Paris, France
- Recruiting
- Hopital Tenon
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Principal Investigator:
- Julie CHAS
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Paris, France
- Recruiting
- Pitié-Salpêtrière Hospital
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Principal Investigator:
- Marc-Antoine VALANTIN
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Paris, France
- Recruiting
- Bichat-Claude Bernard Hospital
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Principal Investigator:
- Anne GERVAIS
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Paris, France
- Recruiting
- Saint Louis Hospital
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Principal Investigator:
- Caroline Lascoux-Combe
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Paris, France
- Recruiting
- Saint-Antoine Hospital
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Principal Investigator:
- Karine Lacombe
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Toulouse, France
- Recruiting
- Hopital Rangueil
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Principal Investigator:
- Laurent Alric
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
All patients followed in the participating centers for their HBV/HDV co-infection and treated or with an indication for treatment with bulevirtide within the french compassionate use program (ATU nominative ou de cohorte) are susceptible to be included.
Patients who already started their treatment will be included retrospectively, after they have signed an informed consent.
Description
Inclusion Criteria:
- Age > 18 years,
- Presenting a chronic HDV infection,
With an indication for or already treated by bulevirtide within the French compassionate program (ATU)
- with compensated cirrhosis or severe liver fibrosis (Metavir fibrosis score 3 or 4 according to liver biopsy or Fibroscan®) or
- moderate liver fibrosis (Metavir fibrosis score 2 according to liver biopsy or Fibroscan®) associated with persistent increase of the ALT level (ALT>2*normal for more than 6 months).
- Who gave his written informed consent before any intervention and the day of inclusion at the latest,
- Affiliated to Health Insurance or to the "Aide Médicale d'Etat" (request for exemption pending).
Exclusion Criteria:
- Contra-indications to treatment with bulevirtide : hypersensibility to the substance or to one of its excipients ,
- Patient participating in another biomedical research with an exclusion period ongoing at inclusion,
- Vulnerable patient (minor, pregnant or breastfeeding woman, adults legally protected: under judicial protection, guardianship, or supervision, persons deprived of their liberty).
- Patients with predictable difficulties of follow-up according to the investigator.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of patients achieving a therapeutic response to bulevirtide
Time Frame: After 48 weeks of treatment
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The therapeutic response is defined as a reduction of RNA HDV of at least 2 log10 and ALT normalization (composite criteria).
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After 48 weeks of treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HDV RNA level
Time Frame: At weeks 4, 8, 12 and every 12 weeks during treatment and weeks 12, 24, 36 and 48 after the end of treatment
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At weeks 4, 8, 12 and every 12 weeks during treatment and weeks 12, 24, 36 and 48 after the end of treatment
|
|
Rate of partial virological response
Time Frame: At weeks 4, 8, 12 and every 12 weeks during treatment
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At weeks 4, 8, 12 and every 12 weeks during treatment
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|
Rate of sustained virological response
Time Frame: 24 weeks after the end of treatment
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24 weeks after the end of treatment
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Rate of sustained virological response
Time Frame: 48 weeks after the end of treatment
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48 weeks after the end of treatment
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Breakthrough rate
Time Frame: At weeks 8, 12 and every 12 weeks during treatment
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At weeks 8, 12 and every 12 weeks during treatment
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|
Number of different HDV resistance variants
Time Frame: Through treatment period, max 3 years
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Through treatment period, max 3 years
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Number of patients with at least one resistance variant
Time Frame: Through treatment period, max 3 years
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Through treatment period, max 3 years
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Rate of biochemical response
Time Frame: At weeks 4, 8, 12 and every 12 weeks during treatment and weeks 12, 24, 36 and 48 after the end of treatment
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Biochemical response is defined as ALT and aspartate aminotransferase (AST) normalization
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At weeks 4, 8, 12 and every 12 weeks during treatment and weeks 12, 24, 36 and 48 after the end of treatment
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Fibrosis level
Time Frame: Every 48 weeks during treatment and week 48 after the end of treatment
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Every 48 weeks during treatment and week 48 after the end of treatment
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|
Rate of patients achieving HBV DNA indetectability
Time Frame: Every 12 weeks during treatment and weeks 12, 24, 36 and 48 after the end of treatment
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Every 12 weeks during treatment and weeks 12, 24, 36 and 48 after the end of treatment
|
|
Rate of patients achieving hepatitis B e (HBe) Ag negativation in patient initially HBeAg- positive
Time Frame: Every 12 weeks during treatment and weeks 12, 24, 36 and 48 after the end of treatment
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Every 12 weeks during treatment and weeks 12, 24, 36 and 48 after the end of treatment
|
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Rate of patients with appearance of anti-HBe Ab
Time Frame: Every 12 weeks during treatment and weeks 12, 24, 36 and 48 after the end of treatment
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Every 12 weeks during treatment and weeks 12, 24, 36 and 48 after the end of treatment
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Rate of patients achieving HBe seroconversion
Time Frame: Every 12 weeks during treatment and weeks 12, 24, 36 and 48 after the end of treatment
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Every 12 weeks during treatment and weeks 12, 24, 36 and 48 after the end of treatment
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Rate of patients achieving HBs Ag negativation
Time Frame: At weeks 4, 8, 12 and every 12 weeks during treatment and weeks 12, 24, 36 and 48 after the end of treatment
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At weeks 4, 8, 12 and every 12 weeks during treatment and weeks 12, 24, 36 and 48 after the end of treatment
|
|
Rate of patients with appearance of anti-HBs Ab
Time Frame: At the end of treatment and weeks 12, 24, 36 and 48 after the end of treatment
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At the end of treatment and weeks 12, 24, 36 and 48 after the end of treatment
|
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Rate of patients achieving HBs seroconversion
Time Frame: At the end of treatment and weeks 12, 24, 36 and 48 after the end of treatment
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At the end of treatment and weeks 12, 24, 36 and 48 after the end of treatment
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Decrease of HBs Ag from baseline
Time Frame: At weeks 4, 8, 12 and every 12 weeks during treatment and weeks 12, 24, 36 and 48 after the end of treatment
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At weeks 4, 8, 12 and every 12 weeks during treatment and weeks 12, 24, 36 and 48 after the end of treatment
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Rate of early discontinuation of treatment due to an adverse event
Time Frame: At weeks 4, 8, 12 and every 12 weeks during treatment and weeks 12, 24, 36 and 48 after the end of treatment
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At weeks 4, 8, 12 and every 12 weeks during treatment and weeks 12, 24, 36 and 48 after the end of treatment
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Rate of adverse event
Time Frame: At weeks 4, 8, 12 and every 12 weeks during treatment and weeks 12, 24, 36 and 48 after the end of treatment
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At weeks 4, 8, 12 and every 12 weeks during treatment and weeks 12, 24, 36 and 48 after the end of treatment
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Death rate
Time Frame: At weeks 4, 8, 12 and every 12 weeks during treatment and weeks 12, 24, 36 and 48 after the end of treatment
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At weeks 4, 8, 12 and every 12 weeks during treatment and weeks 12, 24, 36 and 48 after the end of treatment
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Number and characterization of associated treatments
Time Frame: At weeks 4, 8, 12 and every 12 weeks during treatment and weeks 12, 24, 36 and 48 after the end of treatment
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At weeks 4, 8, 12 and every 12 weeks during treatment and weeks 12, 24, 36 and 48 after the end of treatment
|
|
Quality of life level measured with short-form 12 (SF12) questionnaire
Time Frame: weeks 24, 48, end of treatment and 48 weeks after the end of treatment
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weeks 24, 48, end of treatment and 48 weeks after the end of treatment
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Number of patient's reported outcomes measured with specific questionnaire
Time Frame: weeks 24, 48, end of treatment and 48 weeks after the end of treatment
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weeks 24, 48, end of treatment and 48 weeks after the end of treatment
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Quality of observance measured with specific questionnaire
Time Frame: weeks 24, 48, end of treatment and 48 weeks after the end of treatment
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weeks 24, 48, end of treatment and 48 weeks after the end of treatment
|
Collaborators and Investigators
Investigators
- Principal Investigator: Fabien ZOULIM, Hôpital de la Croix-Rousse
- Principal Investigator: Victor DE LEDINGHEN, Hôpital Haut-Lévêque
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Disease Attributes
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- Chronic Disease
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis D
- Hepatitis D, Chronic
- Hepatitis B, Chronic
- Coinfection
Other Study ID Numbers
- ANRS HD EP01-BULEDELTA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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