Clinical Trials Logo

Clinical Trial Summary

This trial is to assess the efficacy and safety of Polyethylene Glycol thymosin alpha1 (PEG-Tα1), a new long immunomodulator (Category 1.1 of Chemical Drugs) being developed from Hansoh Pharmaceutical of China, in combination with adefovir in HBeAg-positive patients with chronic hepatitis B.


Clinical Trial Description

A total of 116 HBeAg-positive patients were recruited from 12 hospitals in China, and randomized to two groups. The combination group (n= 57) received PEG-Tα1 (1.6 mg/ml, once a week, taken subcutaneously) and adefovir (10 mg, once daily, taken orally) for 24 weeks. The control group (n = 59) received placebo and adefovir. Both groups received adefovir continuously for additional 24 weeks. The primary endpoint was the loss of HBeAg at 48 weeks. The secondary endpoints included 1) loss of hepatitis B virus ( HBV) DNA, 2) HBeAg seroconversion and 3) alanine aminotransferase (ALT) normalization etc. at week 4, 12, 24, 36 and 48. The number of CD4+and CD8+T cells was also determined during 48 weeks. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02366208
Study type Interventional
Source Jiangsu Hansoh Pharmaceutical Co., Ltd.
Contact
Status Completed
Phase Phase 2
Start date May 2011
Completion date August 2013

See also
  Status Clinical Trial Phase
Completed NCT03272009 - Evaluation of the Safety and Pharmacology of EYP001 in HBV Subjects Phase 1
Recruiting NCT01456312 - HBsAg Related Response Guided Therapy Phase 4
Terminated NCT01886300 - An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Positive Chronic Hepatitis B in Vietnam N/A
Completed NCT01023230 - A Study to Assess DV-601 in Subjects With Chronic Hepatitis B Phase 1
Completed NCT00962975 - A Study of Pegasys Monotherapy in Patients With Chronic Hepatitis B Who Have Participated in Previous Studies Phase 1
Terminated NCT00460850 - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Lamivudine Resistant HBeAg-Negative Chronic Hepatitis B. Phase 4
Completed NCT00536263 - PegIntron Treatment of Chronic Hepatitis B e Antigen-Positive Patients (P05170/MK-4031-327) Phase 3
Completed NCT03681132 - The Norwegian Nucleoside Analogue Stop Study Phase 4
Active, not recruiting NCT05473806 - Effects of Pioglitazone and Evogliptin on Hepatic Fibrosis in Patients With Chronic Hepatitis B With Type 2 Diabetes Phase 4
Withdrawn NCT01179594 - A Study of 48 Versus 96 Weeks of Peginterferon Alfa-2a [Pegasys] Treatment, With or Without Entecavir, in Patients With Chronic Hepatitis B. Phase 4
Recruiting NCT05057065 - A Clinical Research on Disease Progression and Intervention of Chronic HepatitisB
Completed NCT04439539 - A Study of JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog (NA) With or Without JNJ-56136379 in Treatment-naive Participants With Hepatitis B e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (HBV) Infection Phase 2
Withdrawn NCT03125213 - A Study Evaluating AL-3778 in Combination With Peginterferon Alpha-2a in Chronic Hepatitis B Subjects Phase 2
Active, not recruiting NCT04782375 - Safely Discontinue Antiviral Treatment in Patients With Chronic Hepatitis B Phase 4
Withdrawn NCT05550519 - A Study in Chronic Hepatitis B e-Antigen Negative Participants After Discontinuation of Nucleos(t)Ide Analog (NA) Treatment Early Phase 1
Completed NCT02693652 - A Study to Evaluate the Safety and Efficacy of Therapeutic Hepatitis B Vaccine Phase 1/Phase 2
Enrolling by invitation NCT04160897 - Risk of Hepatocellular Carcinoma in Patients Treated With ETV vs TDF for Chronic Hepatitis B With Compensated Cirrhosis
Active, not recruiting NCT02588937 - Active Drug Comparative Trial to Evaluate the Antiviral Activity and Safety in Chronic Hepatitis B Patients Phase 4
Completed NCT02612506 - Safety and Pharmacokinetic Study of Hepalatide(L47) in Healthy Volunteers Phase 1
Recruiting NCT02327416 - A Prospective Clinical Trial in Chronic Hepatitis B Patients NAs (Nucleotides or Nucleosides) Experienced (Anchor Study) Phase 3