ORPHA:402823
Hepatitis delta
Also known as: HDV · Hepatitis D virus
Publications
15,333
98.2th percentile
Trials
51
Interventional, condition-specific
Researchers
1,692
Distinct authors in sample
Gene link
—
Readiness
2/6
Stages with a signal
Clinical definition (Orphanet)
Hepatitis delta is a rare hepatic disease characterized by variable degrees of acute hepatitis resulting from infection with the hepatitis delta virus. Occasionally it may present a benign course, but most frequently it manifests with severe liver disease that may include fulminant liver failure, hepatic decompensation and rapid progression to cirrhosis. All patients present concomitant hepatitis B virus infection and an increased risk of developing hepatocellular carcinoma has been reported.
How rare: 1-5 / 10 000 — about one to five people per ten thousand (still uncommon, but less ultra-rare).
Cross-references
Joined from Mondo / Orphanet. MeSH labels may enter searches; UMLS / OMIM / NCIT are stored for reference.
- MONDO:0005789
- MeSH:D003699
- UMLS:C0011226
Additional Mondo synonyms (5)
Hepatitis D · Hepatitis delta virus caused hepatitis · Hepatitis delta virus hepatitis · hepatitis delta · hepatitis type D
Research stages
Trial readiness signals
Where this condition sits on an open-data research pipeline — not how close a treatment is, and not medical advice. Empty stages often mean “not in these databases under this Mondo ID,” not “impossible.”
2/6 stages with a signal
An interventional trial matched this condition name on ClinicalTrials.gov — see trials below.
- Gene identifiedNot found
No GenCC disease–gene assertion in this build
- LiteraturePresent
15,333 matched papers (7,651 in last 10 years) Source
- Phenotype characterisedNot checked
Not yet enriched from Monarch / HPO
- Animal modelNot checked
Not yet enriched from Monarch / Alliance
- Orphan designationNot checked
FDA/EMA orphan-drug designation not enriched yet
- Interventional trialPresent
51 matched on ClinicalTrials.gov (8 recruiting in sample)
Biology
Genes and phenotypes
Gene–disease validity from GenCC, plus phenotypes and animal models joined from Monarch Initiative via Mondo ID — not a clinical diagnosis aid.
Do we know what causes it?
Not yet — the cause hasn't been pinned down in GenCC.
No strong gene–disease assertion joined for this Orphanet entity.
Phenotypes (Monarch / HPO)
Not enriched in this build — Monarch phenotype joins were not run for this record.
Animal models (Monarch / Alliance)
Not enriched in this build.
Literature
Is anyone studying this?
15,333
15,333 papers — among the better-studied rare conditions, though still a fraction of common-disease literature (breast cancer: over 700,000). Median papers in the last 10 years for a rare disease in this dataset (publications denominator n=5449) is 41.
15,333 papers since the earliest indexed year in this search — median last-10-year count for a rare disease in this dataset is 41 (publications denominator n=5449).
7,651 in the last 10 years · medium confidence · 98.2th percentile (publications denominator)
Phrase hits: 15,333 · MeSH hits: 275
Who's working on it?
1,692
Distinct author names in 200 sampled papers — named people below.
Who's working on it?
People publishing on this condition (sampled Europe PMC records). Affiliation is the most recent found in that sample.
- 01Lampertico P17 papers · 2026
Division of Gastroenterology and Hepatology, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Papers in Europe PMC - 02Wedemeyer H13 papers · 2026
D-SOLVE consortium, an EU Horizon Europe funded project (No 101057917), Hannover, Germany.
Papers in Europe PMC - 03Buti M10 papers · 2026
Liver Unit, Hospital Univesitari Vall d'Hebron, Barcelona, Spain.
Papers in Europe PMC - 04Aleman S7 papers · 2026
Department of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden.
Papers in Europe PMC - 05Zoulim F7 papers · 2026
INSERM Unité Mixte de Recherche 1350, PaThLiv IHU EVEREST, Université Claude-Bernard Lyon 1, 69003 Lyon, France; (A.A.R.S.); (E.B.); (F.Z.); (B.T.); (I.C.)
Papers in Europe PMC - 06Casado M6 papers · 2026
Pharmacoeconomics & Outcomes Research Iberia (PORIB), Madrid, Spain.
Papers in Europe PMC - 07Degasperi E6 papers · 2026
Division of Gastroenterology and Hepatology, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Papers in Europe PMC - 08García F6 papers · 2026
Hospital Universitario Clínico San Cecilio, Granada, Spain.
Papers in Europe PMC - 09Sandmann L6 papers · 2026
Department of Gastroenterology, Hepatology, Infectious Diseases and Endocrinology, Hannover Medical School, Hannover, Germany.
Papers in Europe PMC - 10Agarwal K5 papers · 2026
Institute of Liver Studies, King's College Hospital London, United Kingdom.
Papers in Europe PMC
Clinical research
Is a treatment being tested?
51
interventional trials for this specific condition
51 interventional trials matched this specific condition name; 8 currently recruiting in our sample. 3,367 trials are registered for hepatitis, the broader category — shown separately because they may or may not enrol this specific subtype.
Data as of 27 July 2026
51 interventional trials — more than 73% of diseases in the trials denominator have none at all (5114 of 7003; this disease is at the 97.1th percentile).
medium confidence · 97.1th percentile (trials denominator)
Recruiting interventional trials
From the matched ClinicalTrials.gov set
51 interventional trials matched after quoted-phrase search and title/condition post-filter.
- NCT07200908·RECRUITING·A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)
Conditions: Chronic Hepatitis D Infection·Matched via name + MeSH
- NCT07610772·RECRUITING·Safety and Antiviral Activity of a Monoclonal Hepatitis B Antibody: a Phase 1b, Open-label Trial in Individuals With Chronic Hepatitis D Infection
Conditions: Hepatitis D, Chronic · Hepatitis B Chronic Infection·Matched via name + MeSH
- NCT07038863·NOT YET RECRUITING·Community Screening and Management of Hepatitis B, C and Delta in the Mongolian Population Living in France
Conditions: HEPATITIS C (HCV) · Hepatitis B Virus (HBV) · Hepatitis D · Hepatocellular Carcinoma (HCC)·Matched via name + MeSH
- NCT07454837·RECRUITING·Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide
Conditions: Chronic Hepatitis D·Matched via name + MeSH
- NCT06649396·NOT YET RECRUITING·Determination of New Detection and Quantification Thresholds for Serological and Molecular Tests for Hepatitis Delta Virus (HDV) Using Capillary Blood on Blotting Paper (DBS)
Conditions: Delta Hepatitis·Matched via name phrase
- NCT07499544·RECRUITING·A Phase III Study to Evaluate the Efficacy and Safety of Libevitug in Participants With Chronic HDV Infection (D-clear Study)
Conditions: Chronic Hepatitis D Infection·Matched via name + MeSH
- NCT07096193·RECRUITING·Study of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta Virus
Conditions: Chronic Hepatitis Delta·Matched via name phrase
- NCT07309380·NOT YET RECRUITING·Phase III Clinical Trial of Hepalatide in Patients With Chronic Hepatitis D
Conditions: Hepatitis D, Chronic·Matched via name + MeSH
Broader category: hepatitis
3,367
Interventional trials for the parent category, exclusive of NCT IDs already counted above. Eligibility for this subtype is not guaranteed.
Worth raising with a clinician. How we count trials.
Recruiting under the broader category
- NCT06484530·RECRUITING·Gene-guided N-acetyl Cysteine for Prophylaxis of Anti-tuberculous Drug- Induced Hepatitis
Conditions: Tuberculosis (TB) · Isoniazid Toxicity · Rifampicin Toxicity · Pyrazinamide Adverse Reaction·Matched via name phrase
- NCT06381453·RECRUITING·Belimumab in Autoimmune Hepatitis
Conditions: Autoimmune Hepatitis·Matched via name phrase
- NCT07589400·NOT YET RECRUITING·Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of ACT500 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease Complicated With Chronic Hepatitis B
Conditions: Metabolic Dysfunction-associated Steatotic Liver Disease · Chronic Hepatitis b·Matched via name phrase
- NCT05304234·RECRUITING·Liver Cancer Disparities in American Indian and Alaska Native Persons
Conditions: Hepatocellular Carcinoma · Cirrhosis, Liver · Hepatitis B·Matched via name phrase
- NCT05182463·RECRUITING·Peginterferon Treatment Study for Inactive Chronic Hepatitis B Patients
Conditions: Hepatitis B, Chronic·Matched via name phrase
- NCT07137910·RECRUITING·A Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB)
Conditions: Chronic Hepatitis B·Matched via name phrase
- NCT05769816·RECRUITING·A Novel Combination Therapeutic Strategy Aiming to Functional Cure for Chronic Hepatitis B Virus Infection (Sustained HBsAg Loss) (A)
Conditions: Chronic Hepatitis b · Anti-PD-1 Antibody·Matched via name phrase
- NCT07145268·NOT YET RECRUITING·Zinc Sulphate in Treatment Fibrosis in HBV Patient Receiving Antiviral Therapy
Conditions: Liver Fibroses · HBV (Hepatitis B Virus)·Matched via name phrase
- NCT06956482·RECRUITING·PROlonged Corticosteroid Treatment or N-ACetylcysteine for Severe Alcoholic Hepatitis
Conditions: Alcoholic Hepatitis·Matched via name phrase
- NCT07253220·NOT YET RECRUITING·TAF Monotherapy Versus ETV Combined With TAF on the Efficacy and Prognosis of Immunotherapy for Hepatitis B-Related Hepatocellular Carcinoma
Conditions: Hepatitis B · Hepatocellular Carcinoma (HCC)·Matched via name phrase
- NCT07024641·RECRUITING·A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B Virus Infection
Conditions: Hepatitis B Virus Infection·Matched via name phrase
- NCT07017426·NOT YET RECRUITING·Fuzheng Huayu Tablets Reduce the Occurrence of Re-Decompensation Events in Patients With First Decompensation of Hepatitis B-Related Liver Cirrhosis: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study
Conditions: Decompensated Hepatitis B Cirrhosis·Matched via name phrase
- NCT06323681·RECRUITING·Pegylated Interferon α in Previously Interferon-treated CHB(Leading Study)
Conditions: Chronic Hepatitis b·Matched via name phrase
- NCT07342881·RECRUITING·Single Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Pevifoscorvir Sodium (ALG-000184) in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function
Conditions: Chronic Hepatitis B Infection·Matched via name phrase
- NCT04357600·ENROLLING BY INVITATION·Umbilical Cord Mesenchymal Stem Cell for Liver Cirrhosis Patient Caused by Hepatitis B
Conditions: Liver Cirrhoses·Matched via name phrase
Observational and natural-history studies
43 observational studies match this condition. These do not test a treatment and are not counted in the interventional-trial headline, but they are genuine research: natural-history work often defines the endpoints needed for a future rare-disease trial, and families may be able to enroll.
Recruiting or not-yet-recruiting
- NCT06397859·RECRUITING·Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Conditions: Hepatitis D·Matched via name + MeSH
- NCT06248580·RECRUITING·Find HDV and Determine Its Status in Turkey
Conditions: Chronic Hepatitis D Infection · Fibrosis, Liver · Hepatocellular Carcinoma · Cirrhosis, Liver·Matched via name + MeSH
- NCT05451082·NOT YET RECRUITING·Registry-based Study in Patients With Hepatitis D Virus (HDV) Infection in China
Conditions: Hepatitis D·Matched via name + MeSH
- NCT06504485·RECRUITING·Immunological and Virological Characterization of Patients With Chronic HBV-HDV Infection: Outcomes and Response to Bulevirtide Treatment
Conditions: Hepatitis D·Matched via name + MeSH
- NCT07491848·RECRUITING·Oral-Periodontal Evaluation and Assessment of Oral Fluid Biomarkers in Patients With Hepatitis B+D
Conditions: HEPATITIS B CHRONIC · Hepatitis D · Periodontitis·Matched via name + MeSH
- NCT07317011·RECRUITING·"Referral Attivo" Delta, Dallo Screening Alla Presa in Carico.
Conditions: Hepatitis, Delta·Matched via name phrase
- NCT04690972·RECRUITING·"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Conditions: Chronic Liver Disease and Cirrhosis · Liver Cancer · Non-Alcoholic Fatty Liver Disease · Non-Alcoholic Steatohepatitis·Matched via name + MeSH
- NCT04166266·RECRUITING·National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses
Conditions: Hepatitis D, Chronic · Hepatitis B, Chronic·Matched via name + MeSH
- NCT06638320·RECRUITING·Hepatitis Delta Virus Infection: Cross-sectional Study in Patients With Chronic Hepatitis B Virus Infection
Conditions: Hepatitis Delta With Hepatitis B Carrier State · Chronic Hepatitis b·Matched via name phrase
- NCT00001971·RECRUITING·Evaluation of Patients With Liver Disease
Conditions: Hepatitis D · Hepatitis C · Hepatitis B · Liver Disease·Matched via name + MeSH
- NCT06889805·RECRUITING·HDV Screening Study
Conditions: Hepatitis D Virus Infection·Matched via name + MeSH
- NCT06122285·RECRUITING·Effectiveness and Safety of Bulevirtide (BLV) Therapy in Patients With Chronic Hepatitis Delta (CHD) in Italy (D-SHIELD)
Conditions: Hepatitis D·Matched via name + MeSH
- NCT06051045·RECRUITING·Study to Evaluate Efficacy, Safety and Biomarkers of Bulevirtide Treatment in Chronic Hepatitis D Patients
Conditions: Chronic Hepatitis D·Matched via name + MeSH
- NCT05936073·RECRUITING·DELTA DESCRIBE: the French Collaborative Project
Conditions: Hepatitis D·Matched via name + MeSH
- NCT06539052·NOT YET RECRUITING·MIGrant Reflex Test HDV (MIGRED) Project
Conditions: Hepatitis D Virus Infection·Matched via name + MeSH
Where to find support
We do not yet link condition-specific patient organisations. These umbrella groups support undiagnosed and ultra-rare families:
India — NPRD
Last verified 2026-07-26This ORPHAcode is not on our curated NPRD list (direct or Mondo-parent match). That does not decide clinical eligibility; families in India should ask a notified Centre of Excellence about current coverage.
Hand-curated for this project. ORPHAcode mappings are best-effort and may be incomplete or imprecise for umbrella categories. Parent (Mondo) matches mean the policy lists a broader category — confirm eligibility with a Centre of Excellence. Financial entitlements summarised from public policy statements and may change. This is not official government guidance.
How we counted this
Europe PMC query (preferred label + any corrected label + Orphanet and Mondo exact synonyms, stoplisted; unioned with resolved MeSH labels when available). UMLS / OMIM / NCIT cross-references are stored on the overview but are not added to the query string.
"Hepatitis delta" OR "Hepatitis D virus" OR "Hepatitis D" OR "Hepatitis delta virus caused hepatitis" OR "Hepatitis delta virus hepatitis" OR "hepatitis type D"
MeSH descriptor terms unioned into the query: Hepatitis D
ClinicalTrials.gov query (quoted phrases + MeSH via query.cond, plus recall-expansion terms when used):
"Hepatitis delta" OR "Hepatitis D virus" OR "Hepatitis D" OR "Hepatitis delta virus caused hepatitis" OR "Hepatitis delta virus hepatitis" OR "hepatitis type D"
Interventional trials matched via: both, phrase (mesh = registered under a MeSH descriptor no name phrase would catch; recall-expansion = gene / selected parent terms used only for trials).
Study-type breakdown: 51 interventional · 43 observational · 2 expanded access. Only interventional studies enter the trial headline.
Parent-category trials query:
"hepatitis"
Query health: ok — strategies attempted: phrase, mesh; with hits: phrase, mesh
Run this search on ClinicalTrials.gov
Synonyms dropped by stoplist: HDV
Confidence reasoning
- Preferred label is multi-word and distinctive
- 1 synonym(s) dropped by stoplist (may under-count)
- No label/synonym collisions with other diseases in this corpus
Ingested 2026-07-27T15:33:02.877Z
