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A Study to Evaluate Pegylated Interferon Lambda Monotherapy in Patients With Chronic Hepatitis Delta Virus Infection
Phase 2 trial testing Peginterferon Lambda-1A in Hepatitis D, Chronic in 33 participants. Completed in 12 December 2018.
| Lead sponsor | Eiger BioPharmaceuticals |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 33 |
| Start date | 19 October 2016 |
| Primary completion | 20 July 2018 |
| Estimated completion | 12 December 2018 |
| Sites | 4 locations across Pakistan, New Zealand, Israel |
Eiger BioPharmaceuticals — full company profile →
Adults 18 to 65, any sex, with Hepatitis D, Chronic. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
To evaluate the safety and tolerability of treatment with 2 dose levels of Lambda over a 48 week treatment period. To evaluate the effect of treatment with 2 different doses of Lambda on hepatitis D virus (HDV) ribonucleic acid (RNA) levels.
| Group | Value | 95% CI |
|---|---|---|
| Lambda 180 μg | -2.14 | ± 1.81 |
| Lambda 120 μg | -1.16 | ± 2.38 |
To evaluate the proportion of patients with undetectable HDV RNA 24 weeks after the end of treatment
| Group | Value | 95% CI |
|---|---|---|
| Lambda 180 μg | -1.70 | ± 1.70 |
| Lambda 120 μg | -0.66 | ± 1.57 |
Durable Virologic Response (DVR) = below the limit of quantitation in HDV RNA at 24 weeks post-treatment
| Group | Value | 95% CI |
|---|---|---|
| Peginterferon Lambda-1A 180 μg | 5 | |
| Peginterferon Lambda-1A 120 μg | 3 |
Time frame: Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Lambda 180 μg | Lambda 120 μg |
|---|---|---|---|
| jaundice | Hepatobiliary disorders | — | — |
| Drug-Induced Liver Injury (DILI) | Hepatobiliary disorders | — | — |
| Reaction | System | Lambda 180 μg | Lambda 120 μg |
|---|---|---|---|
| Headache | Nervous system disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Fatigue | General disorders | — | — |
| Pyrexia | General disorders | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — |
| Alanine Aminotransferase (ALT) increase | Investigations | — | — |
| Aspartate Aminotransferase (AST) Increase | Investigations | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Chills | General disorders | — | — |
| Injection site erythema | General disorders | — | — |
| Injection site pain | General disorders | — | — |
| Injection site pruritis | General disorders | — | — |
| Jaundice | Hepatobiliary disorders | — | — |
| Blood bilirubin increased | Investigations | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Pruritis | Skin and subcutaneous tissue disorders | — | — |
| Influenza like illness | General disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Dysgeusia | Nervous system disorders | — | — |
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| gamma-glutamyl transferase (GGT) increased | Investigations | — | — |
| international normalized ratio (INR) increased | Investigations | — | — |
| Neutrophil count decreased | Investigations | — | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — | — |
| Erythema | Skin and subcutaneous tissue disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Asthenia | General disorders | — | — |
| Feeling cold | General disorders | — | — |
Most-reported serious reactions: jaundice, Drug-Induced Liver Injury (DILI).
Data from ClinicalTrials.gov NCT02765802 adverse events section.
To evaluate safety and tolerability of lambda over a 48-week treatment period in HDV patients.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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