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NCT05203055
Peginterferon Alpha-2b Therapy in Chronic Hepatitis Patients With Normal ALT Level and Low Viremia
Phase 1, PHASE2 trial testing Peginterferon alpha-2b in Chronic Hepatitis B Patients With a Normal ALT Level and Low Viremia in 300 participants. Status unknown.
10 December 2022
Quick facts
| Lead sponsor | Fuzhou General Hospital |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 300 |
| Start date | 10 December 2021 |
| Primary completion | 10 December 2022 |
| Estimated completion | 10 December 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- Peginterferon alpha-2b — full drug profile →
- Nucleotide Analog — full drug profile →
- pulse peginterferon alpha-2b — full drug profile →
Conditions studied
- Chronic Hepatitis B Patients With a Normal ALT Level and Low Viremia — all drugs for Chronic Hepatitis B Patients With a Normal ALT Level and Low Viremia →
Sponsor
Fuzhou General Hospital
Who can join
Adults 18 to 60, any sex, with Chronic Hepatitis B Patients With a Normal ALT Level and Low Viremia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To date, antiviral treatment is not recommended for chronic hepatitis B patients with a normal ALT level and low viremia. The strategy is to closely monitor the patients. However, evidence suggests that these group are at risk of gradual disease progression and development of hepatocellular carcinoma. Peginterferon eliminates the hepatitis B virus through immune regulation and induction of antiviral protein expression. For patients with low viral load, the clinical cure rate is potentially promising. In this study, we aim to investigate the efficacy and safety of peginterferon alpha-2b therapy in selected chronic hepatitis B patients with normal ALT level and low viremia. It is expected to obtain a satisfactory curative effect. Peginterferon is a marketed drug available in Chinese clinics with indications of anti-hepatitis B virus.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05203055
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
Other trials of Peginterferon alpha-2b
Trials testing the same drug.
- NCT01590225 — Efficacy and Safety of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin in Pediatric Subjects With Ch · Phase 3 · withdrawn
Other Fuzhou General Hospital trials
Trials by the same sponsor.
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- NCT06775587 — SERS-Based Serum Molecular Spectral Screening for Benign and Malignant Pulmonary Proliferative Nodules · not yet recruiting
- NCT06775002 — SERS-Based Serum Molecular Spectral Screening for Lung Cancer Type · not yet recruiting
- NCT06775015 — SERS-Based Serum Molecular Spectral Detection of Invasive Lung Cancer · not yet recruiting
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 NCT05203055 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fuzhou General Hospital
- Last refreshed: 24 January 2022
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