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NCT04426968
A Phase II Study of Hepalatide in Subjects With Chronic Hepatitis B
Phase 2 trial testing Hepalatide 2.1mg in Hepatitis B, Chronic in 96 participants. Completed in 29 November 2023.
1 November 2023
Quick facts
| Lead sponsor | Shanghai HEP Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 96 |
| Start date | 18 June 2021 |
| Primary completion | 1 November 2023 |
| Estimated completion | 29 November 2023 |
| Sites | 12 locations across China |
Drugs / interventions tested
- Hepalatide 2.1mg — full drug profile →
- Hepalatide 4.2mg
- Hepalatide 6.3mg
- placebo 2.1mg — full drug profile →
- placebo 4.2mg — full drug profile →
- placebo 6.3mg — full drug profile →
- Pegylated Interferon — full drug profile →
Conditions studied
- Hepatitis B, Chronic — all drugs for Hepatitis B, Chronic →
Sponsor
Shanghai HEP Pharmaceutical Co., Ltd. — full company profile →
Who can join
Adults 18 to 60, any sex, with Hepatitis B, Chronic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A Phase II Randomized, Double-blind, Placebo-controlled, Multi-center, Dose-effect Relationship Study of Hepalatide for Injection Combined with Pegylated Interferon in Subjects with Chronic Hepatitis B
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Current Best Practice in Hepatitis B Management and Understanding Long-term Prospects for Cure.
Yardeni D, Chang KM, Ghany MG. · · 2023 · cited 52× · PMID 36243037 · DOI 10.1053/j.gastro.2022.10.008 -
Current trends and advances in antiviral therapy for chronic hepatitis B.
Li J, Liu S, Zang Q, Yang R, et al · · 2024 · cited 7× · PMID 38945693 · DOI 10.1097/cm9.0000000000003178 -
Navigating the Viral Hepatitis Drug Landscape: New Discoveries and Enduring Challenges. A Narrative Review.
Sun HM, Wang XY, Xu HQ, Gao YH. · · 2026 · PMID 41817955 · DOI 10.1007/s40121-026-01321-8
Verify or expand the search:
- PubMed search for NCT04426968
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hepatitis B, Chronic
Currently open trials in the same condition.
- NCT07370207 — Phase 2 Study of AHB-137 in HBeAg Negative Chronic Hepatitis B (CHB) Participants in Asia Pacific Region · Phase 2 · recruiting
- NCT06550622 — Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion · recruiting
- NCT06550128 — Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB). · Phase 2 · active not recruiting
- NCT06525909 — A Real-world Study of Staging and Grading of Clinical Immune Status in Chronic Hepatitis B · recruiting
- NCT05937178 — Real-world Study Optimizing Nucleotide-analogues · recruiting
Other Shanghai HEP Pharmaceutical Co., Ltd. trials
Trials by the same sponsor.
- NCT05827146 — Study of Hepalatide in Chronic Hepatitis D(CHD) Patients · Phase 2 · completed
- NCT05244057 — A Study of Hepalatide Combined With TAF and PEG-IFN as Finite Treatment of Chronic Hepatitis B Patients · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04426968 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai HEP Pharmaceutical Co., Ltd.
- Last refreshed: 27 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04426968.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing