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NCT03448744
Efficacy and Safety of Combination Therapy of Thymalfasin and Entecavir in HBeAg-positive ETV-experienced Patients
Phase 4 trial testing Thymosin Alpha1 in Chronic Hepatitis b in 240 participants. Status unknown.
30 December 2018
Quick facts
| Lead sponsor | Wen-hong Zhang |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 240 |
| Start date | 25 October 2017 |
| Primary completion | 30 December 2018 |
| Estimated completion | 30 December 2018 |
| Sites | 1 location across China |
Drugs / interventions tested
- Thymosin Alpha1 — full drug profile →
- Entecavir (ENTECAVIR) — full drug profile →
Conditions studied
- Chronic Hepatitis b — all drugs for Chronic Hepatitis b →
Sponsor
Wen-hong Zhang — full company profile →
Who can join
Adults 18 to 55, any sex, with Chronic Hepatitis b. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multicenter, randomized, open-label control trial of two arms conducted at 10 centres in China.The aim was to investigate whether sequential combination therapy with Thymosin alpha 1 and entecavir is superior to continuous ETV monotherapy in HBeAg-positive chronic hepatitis B patients with previous long-term entecavir therapy (≥ 2 years), and to select the optimal patients who may benefit from sequential combination therapy.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Development of Direct-acting Antiviral and Host-targeting Agents for Treatment of Hepatitis B Virus Infection.
Xia Y, Liang TJ. · · 2019 · cited 91× · PMID 30243618 · DOI 10.1053/j.gastro.2018.07.057
Verify or expand the search:
- PubMed search for NCT03448744
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Thymosin Alpha1
Trials testing the same drug.
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- NCT06139419 — The Impact of Thymosin α-1 on the Efficacy of Concurrent Chemoradiotherapy Followed by Immunotherpay Consolidation for L · Phase 2 · active not recruiting
- NCT05487469 — Thymosin α1 Use in Rheumatic Heart Disease Patients Undergoing Cardiac Surgery on Cardiopulmonary Bypass · NA · unknown
- NCT04901104 — Long-term Prognosis of Patients With Sepsis After Immunotherapy · not yet recruiting
- NCT05086614 — Thymosin-alpha 1 for Adjuvant Treatment After Radical Resection of High-risk Stage II and III Colorectal Cancer · Phase 3 · recruiting
Other recruiting trials for Chronic Hepatitis b
Currently open trials in the same condition.
- NCT07090759 — To Evaluate the Efficacy, Safety and Population Pharmacokinetics of GST-HG141 in Patients With Chronic Hepatitis B (CHB) · Phase 3 · recruiting
- NCT06989788 — A Study to Evaluate the Safety and Immunogenicity of an Investigational Vaccine for Chronic Hepatitis B Virus Infection, · Phase 1 · active not recruiting
- NCT06885710 — HBV-Specific TCR-T Cell Therapy Combined With Nucleos(t)Ide Analogues in Chronic Hepatitis B Patients · Phase 1 · recruiting
- NCT06671093 — Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B · Phase 1 · recruiting
- NCT06638320 — Hepatitis Delta Virus Infection: Cross-sectional Study in Patients With Chronic Hepatitis B Virus Infection · active not recruiting
Other Wen-hong Zhang trials
Trials by the same sponsor.
- NCT05965388 — Predictive Value of HBV pgRNA on Long-term Outcomes in Hepatitis B Patients Treated With Antiviral Therapy · not yet recruiting
- NCT04946682 — Optimal Encephalitis/Meningitis Roadmap Via Precise Diagnosis and Treatment · NA · unknown
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 NCT03448744 (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 Wen-hong Zhang
- Last refreshed: 28 February 2018
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/NCT03448744.
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