Clinical trial • Phase III • Infectious Disease|Rare Disease

Elebsiran for Chronic hepatitis D (HDV) infection

Phase III trial of Elebsiran for Chronic hepatitis D (HDV) infection.

Overview

Trial Therapeutic Area
Infectious Disease|Rare Disease
Trial Disease
Chronic hepatitis D (HDV) infection
Trial Stage
Phase III
Drug Modality
Oligonucleotide|Monoclonal antibody|Peptide/protein/enzyme
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
31-01-2025
First CTIS Authorization Date
26-05-2025

Trial design

Randomised, open-label, hepcludex (bulevirtide) 2 mg subcutaneous once daily (comparator; marketed product: hepcludex 2 mg powder for solution for injection; route: subcutaneous injection; dosing referenced as 2 mg sc qd in eligibility and product details)-controlled Phase III trial across 38 sites in Romania, Spain, Austria and others.

Randomised
Yes
Open Label
Yes
Comparator
HEPCLUDEX (bulevirtide) 2 mg subcutaneous once daily (comparator; marketed product: HEPCLUDEX 2 mg powder for solution for injection; route: subcutaneous injection; dosing referenced as 2 mg SC QD in eligibility and product details)
Target Sample Size
136
Trial Duration For Participant
1680

Eligibility

Recruits 136 Vulnerable population is selected for this trial. Informed consent is obtained via Subject Information Sheet and Informed Consent Form (multiple L1 ICF documents listed). There are specific ICF documents including a 'Pregnant Partner' ICF and optional ICFs; main and optional consent documents are provided in multiple languages (English, Romanian, French, Spanish, German, Italian) as indicated in the published documents list..

Vulnerable Population
Vulnerable population is selected for this trial. Informed consent is obtained via Subject Information Sheet and Informed Consent Form (multiple L1 ICF documents listed). There are specific ICF documents including a 'Pregnant Partner' ICF and optional ICFs; main and optional consent documents are provided in multiple languages (English, Romanian, French, Spanish, German, Italian) as indicated in the published documents list.

Inclusion criteria

  • {"criterion_text":"- Adult men and women aged ≥ 18 years (or age of legal consent, whichever is older) to ≤ 70 years at the time of signing informed consent\n- HDV RNA ≥ 500 IU/mL at screening\n- Receiving BLV 2 mg SC QD for ≥ 24 weeks at Day 1\n- Noncirrhotic or compensated cirrhotic liver disease at screening\n- Body mass index (BMI) ≥ 18 kg/m2 to ≤ 40 kg/m2\n- On NRTI therapy against HBV for at least 12 weeks prior to Day 1 or have HBV DNA < 10 IU/mL at screening, and currently on locally approved NRTI therapy. Participants must be on one of the following NRTI therapies starting at Day 1: tenofovir alafenamide (taken alone or as part of a fixed-dose combination therapy), tenofovir disoproxil fumarate (taken alone or as part of a fixed-dose combination therapy), or entecavir"}

Exclusion criteria

  • {"criterion_text":"- Current or prior history of any of the following: a. Clinically significant laboratory abnormalities, co-morbid medical condition (other than HBV/HDV coinfection) or planned medical procedure that may interfere with the participant’s treatment, assessment, or compliance with the protocol. b. Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy. c. Current or previous (within 24 months of screening) clinically identified hepatic decompensationd. d. Bone marrow, peripheral blood stem-cell or solid organ transplantation e. Psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within the last 5 years. f. Malignancy diagnosed or treated within 5 years (recent localized treatment of squamous or non-invasive basal cell skin cancers is permitted; ductal carcinoma in situ and cervical carcinoma in situ is allowed if appropriately treated prior to screening); participants under evaluation for malignancy are not eligible. g. Significant drug allergy (such as anaphylaxis or hepatotoxicity)\n- One or more additional known primary or secondary causes of liver disease, other than hepatitis B or hepatitis D (ie, alcoholism, autoimmune hepatitis, malignancy with hepatic involvement, hemochromatosis, Wilson’s disease, other congenital or metabolic condition affecting the liver, congestive heart failure, etc).\n- History of clinically significant immune complex disease as determined by the Investigator\n- History of anaphylaxis, allergic reactions, hypersensitivity, or intolerance to study drug, study drug component (ex. Oligonucleotide and/or GalNAc), its metabolites or excipients\n- Participants with active HCV (participants with HCV antibodies can be enrolled if screening HCV RNA PCR test is negative).\n- Participants with uncontrolled HIV-1 infection (defined as HIV-1 >200 copies/mL or CD4+ T-cell counts < 500/mm3 is within the last 12 months) or any HIV-2 infection.\n- Participants with HAV (participants who are HAV IgM positive can be enrolled if asymptomatic and HAV IgG positive).\n- Participants with HEV (participants who are HEV IgM positive can be enrolled if asymptomatic and HEV IgG positive). In cases where acute infection status cannot be determined by serologies a serum or stool HEV RT-PCR can be obtained. The participant is ineligible if PCR is positive\n- Current therapy or therapy within 24 weeks of of first study intervention administration with an immunomodulatory agent (eg, IFN-α), immune checkpoint inhibitors, immunosuppressants (eg, diseasemodifying antirheumatic drugs), cytotoxic or chemotherapeutic agent, or chronic systemic corticosteroids (equivalent of 10mg prednisone QD)."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Part I: HDV RNA < LLOQ, TND at Week 24","definition_or_measurement_approach":"HDV RNA measured; endpoint defined as HDV RNA below the lower limit of quantification (LLOQ) / target not detected (TND) at Week 24"}
  • {"endpoint_text":"- Part 2: HDV RNA < LLOQ, TND 24 weeks after end of treatment","definition_or_measurement_approach":"HDV RNA measured; endpoint defined as HDV RNA below the lower limit of quantification (LLOQ) / target not detected (TND) 24 weeks after end of treatment"}

Secondary endpoints

  • {"endpoint_text":"- Part I: HDV RNA < LLOQ, TND at Week 48 and Week 96 Change from baseline in HDV RNA at Week 48 and Week 96","definition_or_measurement_approach":"HDV RNA measured; change from baseline assessments at Weeks 48 and 96; categorical viral suppression endpoints as <LLOQ/TND"}
  • {"endpoint_text":"- Part I: Change from baseline in ALT at Week 24, Week 48 and Week 96","definition_or_measurement_approach":"ALT laboratory measurement; change from baseline at specified weeks"}
  • {"endpoint_text":"- Part I: Incidence of TEAEs and SAEs through Week 24, Week 48 and Week 96","definition_or_measurement_approach":"Safety surveillance of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through specified timepoints"}
  • {"endpoint_text":"- Part I: • Incidence of decompensated cirrhosis (clinical event or CPT score ≥ 7) through Week 48 and Week 96 • Incidence of HCC or progression to liver failure requiring transplantation or resulting in death through Week 48 and Week 96","definition_or_measurement_approach":"Clinical event adjudication and CPT score assessments; investigator-reported incidence of HCC or progression to liver failure"}
  • {"endpoint_text":"- Part I: Change from baseline in liver stiffness as measured by liver elastography at Week 48 and Week 96","definition_or_measurement_approach":"Liver elastography measurement; change from baseline at Weeks 48 and 96"}
  • {"endpoint_text":"- Part I: • Change from baseline in HBsAg at Week 24, Week 48 and Week 96 • Categorical summary of HBsAg at Week 24, Week 48 and Week 96","definition_or_measurement_approach":"Serum HBsAg quantification; change from baseline and categorical summaries at specified weeks"}
  • {"endpoint_text":"- Part I: • ALT ≤ ULN and HDV RNA < LLOQ, TND at Week 24, Week 48 and Week 96 • ALT ≤ ULN at Week 24, Week 48 and Week 96","definition_or_measurement_approach":"Combination endpoints using ALT laboratory values relative to upper limit of normal (ULN) and HDV RNA < LLOQ/TND at specified weeks"}
  • {"endpoint_text":"- Part I: • ALT ≤ ULN and HDV RNA < LLOQ, TND at Week 24, Week 48 and Week 96 • ALT ≤ ULN at Week 24, Week 48 and Week 96","definition_or_measurement_approach":"See prior; ALT and HDV RNA combination and ALT-alone assessments"}
  • {"endpoint_text":"- Part II: • HDV RNA < LLOQ, TND at Week 144, Week 192 and Week 240 • Change from baseline in HDV RNA from tobevibart+elebsiran interruption at Week 96 to Week 120, Week 144, Week 192 and Week 240","definition_or_measurement_approach":"HDV RNA measured at long-term follow-up weeks (144,192,240); change from baseline after interruption timepoints"}
  • {"endpoint_text":"- Part II: • HDV RNA < LLOQ, TND at Week 120, Week 144, Week 192 and Week 240 • Change from baseline in HDV RNA at Week 120, Week 144, Week 192 and Week 240","definition_or_measurement_approach":"HDV RNA suppression and change from baseline at specified long-term follow-up weeks"}
  • {"endpoint_text":"- Part II: • Change from baseline in ALT from tobevibart+elebsiran interruption at Week 96 to Week 120, Week 144, Week 192 and Week 240","definition_or_measurement_approach":"ALT laboratory assessments change from baseline at post-interruption timepoints"}
  • {"endpoint_text":"- Part II: Incidence of AEs, SAEs and lab abnormalities from time of tobevibart+elebsiran interruption (Week 96) through Week 120, Week 144, Week 192 and Week 240.","definition_or_measurement_approach":"Safety surveillance of AEs/SAEs and laboratory abnormalities from interruption through long-term follow-up"}
  • {"endpoint_text":"- Part II: • Incidence of decompensation through Week 144, Week 192 and Week 240 • Incidence of HCC or progression to liver failure requiring transplantation or resulting in death through Week 144, Week 192 and Week 240","definition_or_measurement_approach":"Clinical event incidence assessment for decompensation, HCC, progression to liver failure at long-term follow-up"}
  • {"endpoint_text":"- Part II: Change from baseline in liver stiffness as measured by liver elastography at Week 144, Week 192 and Week 240","definition_or_measurement_approach":"Liver elastography measurements; change from baseline at long-term follow-up"}
  • {"endpoint_text":"- Part II: Categorical summary of HBsAg at Week 120, Week 144, Week 192 and Week 240","definition_or_measurement_approach":"Categorical summaries of serum HBsAg at specified long-term follow-up weeks"}
  • {"endpoint_text":"- Part II: TEAEs, SAEs through Week 120, Week 144, Week 192 and Week 240","definition_or_measurement_approach":"Safety surveillance of treatment-emergent and serious adverse events at long-term follow-up"}
  • {"endpoint_text":"- Part II: • ALT ≤ ULN and HDV RNA < LLOQ, TND at Week 120, Week 144, Week 192 and Week 240 • ALT ≤ ULN at Week 120, Week 144, Week 192 and Week 240","definition_or_measurement_approach":"Combination and ALT-alone endpoints using laboratory thresholds and HDV RNA suppression at long-term follow-up"}
  • {"endpoint_text":"- Part II: ALT ≤ ULN and HDV RNA < LLOQ, TND at Week 120, Week 144, Week 192 and Week 240 • ALT ≤ ULN at Week 120, Week 144, Week 192 and Week 240","definition_or_measurement_approach":"See prior; ALT and HDV RNA combination and ALT-alone assessments at long-term follow-up"}

Recruitment

Digital Remote Recruitment
True - digital methods include online advertisements (banners), social media posts, and digital patient brochures/online study information; materials are provided country-specifically (e.g., FR, ES, DE, RO, IT, GBR versions)
Planned Sample Size
136
Recruitment Window Months
75
Consent Approach
Informed consent is obtained from adult participants (study age eligibility ≥18). Subject Information Sheet and Informed Consent Form (L1_SIS and ICF Main, FSR, optional ICFs, Pregnant Partner ICF) are provided; documents are available in multiple languages (English, Romanian, French, Spanish, German, Italian) as indicated in the published documents list. No paediatric assent is applicable because enrolment is restricted to adults.

Methods

  • Online advertisements (banners) targeting potential participants/public (country-specific banners noted)
  • Social media clinical trial posts targeting potential participants (country-specific versions available)
  • Patient brochures (digital and print) to inform potential participants about Hepatitis D and the study (multiple languages and country versions)
  • Digital patient brochure / digital patient study guide (used for participant information and engagement)
  • Physician referral letters to engage clinicians and facilitate referrals to trial sites
  • Study information slides and 'About Clinical Research Studies' brochures for general awareness

Geography

Total Number Of Sites
38
Total Number Of Participants
136

Romania

Earliest CTIS Part Ii Submission Date
13-02-2025
Latest Decision Or Authorization Date
25-11-2025
Processing Time Days
285
Number Of Sites
5
Number Of Participants
46

Sites

Site Name
Spitalul Clinic De Boli Infectioase Si Tropicale Dr. Victor Babes
Department Name
Infectious Diseases
Contact Person Name
Simin Aysel Florescu
Contact Person Email
siminflorescu@yahoo.com
Site Name
Fundatia Dr. Victor Babes
Department Name
Infectious Diseases
Contact Person Name
George Sebastian Gherlan
Contact Person Email
george.gherlan@umfcd.ro
Site Name
Institutul Clinic Fundeni
Department Name
Infectious Diseases
Contact Person Name
Elena Laura Iliescu
Contact Person Email
laura_ate@yahoo.com
Site Name
Institutul National De Boli Infectioase Prof.Dr.Matei Bals
Department Name
Infectious Diseases
Contact Person Name
Anca Streinu-Cercel
Contact Person Email
anca_sc@yahoo.com
Site Name
Centrul Medical Renasterea S.R.L.
Department Name
Internal Medicine
Contact Person Name
Paul Mitrut
Contact Person Email
paulmitrut@yahoo.com

Spain

Earliest CTIS Part Ii Submission Date
21-03-2025
Latest Decision Or Authorization Date
02-06-2025
Processing Time Days
73
Number Of Sites
5
Number Of Participants
9

Sites

Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Gastroenterología y Hepatología
Contact Person Name
Joaquín Cabezas González
Contact Person Email
joaquin.cabezas@scsalud.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Unidad de Hepatología
Contact Person Name
María Butí Ferret
Contact Person Email
mariabutiferret@gmail.com
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Servicio de Aparato Digestivo
Contact Person Name
Fernando Díaz Fontenla
Contact Person Email
fernando.diaz@salud.madrid.org
Site Name
Hospital Universitario La Paz
Department Name
Servicio Digestivo
Contact Person Name
Antonio Olveira Martín
Contact Person Email
aolveiram@gmail.com
Site Name
Hospital Clinic De Barcelona
Department Name
Unidad de Hepatología
Contact Person Name
Sabela Lens García
Contact Person Email
slens@clinic.cat

Austria

Earliest CTIS Part Ii Submission Date
29-04-2025
Latest Decision Or Authorization Date
06-11-2025
Processing Time Days
191
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Medical University Of Vienna
Department Name
Universitätsklinik für Innere Medizin III, Klinische Abteilung für Gastroenterologie und Hepatologie
Contact Person Name
Thomas Reiberger
Site Name
Medizinische Universitaet Innsbruck
Department Name
Universitätsklinik für Innere Medizin I
Contact Person Name
Heinz Zoller
Contact Person Email
heinz.zoller@i-med.ac.at

Italy

Earliest CTIS Part Ii Submission Date
14-04-2025
Latest Decision Or Authorization Date
12-12-2025
Processing Time Days
242
Number Of Sites
9
Number Of Participants
20

Sites

Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
SC Gastroenterology and Hepatology
Contact Person Name
Pietro Lampertico
Contact Person Email
pietro.lampertico@unimi.it
Site Name
Azienda Ospedaliero Universitaria Ospedali Riuniti
Department Name
S.C. Malattie Infettive
Contact Person Name
Sergio Lo Caputo
Contact Person Email
sergio.locaputo@unifg.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
U.O. Hepatology
Contact Person Name
Maurizia Rossana Brunetto
Contact Person Email
maurizia.brunetto@unipi.it
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
SC Gastroenterology and Hepatology
Contact Person Name
Mauro Viganò
Contact Person Email
mvigano@asst-pg23.it
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
SC Gastroentherology U
Contact Person Name
Alessia Ciancio
Contact Person Email
alessia.ciancio@unito.it
Site Name
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
Department Name
Infectious and Tropical Diseases
Contact Person Name
Annalisa Saracino
Contact Person Email
annalisa.saracino@uniba.it
Site Name
Azienda Sanitaria Locale Citta Di Torino
Department Name
Infectious Diseases
Contact Person Name
Letizia Marinaro
Site Name
Humanitas Mirasole S.p.A.
Department Name
U.O Gastroenterology, Internal Medicine and Hepatology
Contact Person Name
Alessio Aghemo
Contact Person Email
alessio.aghemo@hunimed.eu
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino (additional site listing)
Department Name
SC Gastroentherology U

France

Earliest CTIS Part Ii Submission Date
11-03-2025
Latest Decision Or Authorization Date
12-03-2026
Processing Time Days
367
Number Of Sites
11
Number Of Participants
30

Sites

Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Hepatology
Contact Person Name
Caroline JEZEQUEL
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Hepatogastroenterology and transplantation
Contact Person Name
Madgalena MESZAROS
Contact Person Email
m-meszaros@chu-montpellier.fr
Site Name
Centre Hospitalier De Versailles
Department Name
Hepatology and Gastroenterology
Contact Person Name
Christiane STERN
Contact Person Email
cstern@ght78sud.fr
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Hepatogastroenterology
Contact Person Name
Paul CARRIER
Contact Person Email
paul.carrier@chu-limoges.fr
Site Name
Hopital Beaujon
Department Name
Hepatology
Contact Person Name
Tarik ASSELAH
Contact Person Email
tarik.asselah@aphp.fr
Site Name
Assistance Publique Hopitaux De Paris (Creteil)
Department Name
Hepatology
Contact Person Name
Vincent LEROY
Contact Person Email
vincent.leroy2@aphp.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Hepatogastroenterology
Contact Person Name
Juliette FOUCHER
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Hepatology
Contact Person Name
Sophie METIVIER
Contact Person Email
metivier.s@chu-toulouse.fr
Site Name
Hopital Paul Brousse
Department Name
Centre Hépato-Biliaire
Contact Person Name
Audrey COILLY
Contact Person Email
audrey.coilly@aphp.fr
Site Name
Hospices Civils De Lyon
Department Name
Hepatogastroenterology
Contact Person Name
Fabien ZOULIM
Contact Person Email
fabien.zoulim@chu-lyon.fr
Site Name
Assistance Publique Hopitaux De Paris (Bobigny)
Department Name
Hepatology
Contact Person Name
Nathalie GANNE
Contact Person Email
nathalie.ganne@aphp.fr

Germany

Earliest CTIS Part Ii Submission Date
15-05-2025
Latest Decision Or Authorization Date
02-04-2026
Processing Time Days
323
Number Of Sites
6
Number Of Participants
28

Sites

Site Name
Goethe University Frankfurt
Department Name
Gastroenterologie und Hepatologie
Contact Person Name
Kathrin Andrea Sprinzl
Contact Person Email
sprinzl@med.uni-frankfurt.de
Site Name
Medizinische Hochschule Hannover
Department Name
Gastroenterologie, Hepatologie und Endokrinologie
Contact Person Name
Katja Deterding
Contact Person Email
deterding.katja@mh-hannover.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik fuer Gastroenterologie und Hepatologie
Contact Person Name
Susanne Beckebaum
Contact Person Email
susanne.beckebaum@uk-essen.de
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Innere Medizin IV - Gastroenterologie
Contact Person Name
Shirin Nkongolo
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Med. Klinik fuer Hepatologie und Gastroenterologie
Contact Person Name
Muenevver Demir
Contact Person Email
muenevver.demir@charite.de
Site Name
Universitaet Leipzig
Department Name
Medicine II, Hepatology
Contact Person Name
Florian van Boemmel

Sponsor

Primary sponsor

Full Name
Vir Biotechnology Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Ppd Inc.
Responsibilities
sponsorDuties codes: ["6"]
Name
QPS LLC
Responsibilities
sponsorDuties codes: ["4"]
Name
IQVIA Limited
Responsibilities
sponsorDuties codes: ["12","15","5"]; code 15 value: 'Study scales (questionaires) and eCOA tablet'
Name
4g Clinical LLC
Responsibilities
sponsorDuties codes: ["3"]
Name
Syneos Health Inc.
Responsibilities
sponsorDuties: CTA budget ancilliary documents (code "15")
Name
Medidata Solutions Inc.
Responsibilities
sponsorDuties codes: ["7"]
Name
Q Squared Solutions Limited
Responsibilities
sponsorDuties codes: ["4"]

Third parties

  • {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Ppd Inc.","duties_or_roles":"sponsorDuties codes: [\"6\"]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"FGK Representative Service B.V.","duties_or_roles":"sponsorDuties: EU legal representative (code \"15\")","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"QPS LLC","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Client-Pharma Limited","duties_or_roles":"sponsorDuties: Water for injection vendor for Romania (code \"15\")","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Ubc Late Stage (UK) Limited","duties_or_roles":"sponsorDuties codes: [\"8\"]","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"Cerba Research","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"sponsorDuties codes: [\"3\"]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"sponsorDuties: CTA budget ancilliary documents (code \"15\")","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: [\"7\"]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: [\"12\",\"15\",\"5\"] with code 15 value 'Study scales (questionaires) and eCOA tablet'","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"sponsorDuties: IMP distribution, QP release (code \"15\")","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
VIR-2218
Active Substance
Elebsiran
Modality
Oligonucleotide
Routes Of Administration
Subcutaneous
Route
Subcutaneous
Authorisation Status
prodAuthStatus: 1
Orphan Designation
Yes
Investigational Product Name
VIR-3434
Active Substance
Tobevibart
Modality
Monoclonal antibody
Routes Of Administration
Subcutaneous use
Route
Subcutaneous
Authorisation Status
prodAuthStatus: 1
Orphan Designation
Yes
Investigational Product Name
HEPCLUDEX 2 mg powder for solution for injection (bulevirtide)
Active Substance
Bulevirtide
Modality
Peptide/protein/enzyme
Routes Of Administration
Subcutaneous injection
Route
Subcutaneous injection
Authorisation Status
Marketing authorisation present (marketingAuthNumber: EU/1/20/1446/001; prodAuthStatus: 2)
Orphan Designation
Yes
Starting Dose
2 mg
Dose Levels
2 mg daily (as per product details and eligibility criteria)
Frequency
Once daily (QD)
Maximum Dose
2 mg daily (max total 336 mg over treatment period indicated in product data)
Combination Treatment
Yes

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