A Multicenter, Prospective Cohort Study: Efficacy of NA Combined With PEG-IFN-α2b Continuous Versus Pulsed Therapy for 96 Weeks in Patients With Chronic Hepatitis B. (EPCP)

NCT05922306 EARLY_PHASE1 RECRUITING

Previous studies have shown that there are alterations in the number and affinity of interferon receptors during interferon therapy and that such alterations recover to varying degrees some time after the end of treatment. It can be conjectured that the rest period of pulsed therapy facilitates the recovery of type I interferon receptors and thus the next round of IFN therapy compared to a continuous regimen of interferon.

Details

Lead sponsor	Anhui Medical University
Phase	EARLY_PHASE1
Status	RECRUITING
Enrolment	1084
Start date	2023-07
Completion	2027-12

Conditions

• Hepatitis B, Chronic

Interventions

• PEGylated recombinant human interferon alpha-2b injection
• PEGylated recombinant human interferon alpha-2b injection

Primary outcomes

• HBsAg negative conversion rate after 96 weeks of treatment — 96 weeks
  After 96 weeks of treatment, 5 ml of blood will be drawn from the patient, serum will be extracted, and HBsAg values will be quantified by chemiluminescence assay; samples less than 0.5 ng/ml will be judged as negative.
• HBsAb conversion rate after 96 weeks of treatment — 96 weeks
  After 96 weeks of treatment, 5 ml of blood will be drawn from the patient, serum will be extracted, and HBsAb values will be quantified by chemiluminescence; samples greater than 10 miu/ml 0.5 will be judged as positive.

Countries

China