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Efficacy and Safety of Combination Therapy of Thymalfasin and Entecavir in HBeAg-positive ETV-experienced Patients

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ClinicalTrials.gov Identifier: NCT03448744
Recruitment Status : Unknown
Verified February 2018 by Wen-hong Zhang, Huashan Hospital.
Recruitment status was:  Recruiting
First Posted : February 28, 2018
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Wen-hong Zhang, Huashan Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis b Drug: Thymosin Alpha1 Drug: Entecavir Phase 4

Detailed Description:
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 (≥ 1 years), and to select the optimal patients who may benefit from sequential combination therapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Open-label Control Study to Evaluate Efficacy and Safety of Combination Therapy of Thymalfasin and Entecavir in HBeAg-positive ETV-experienced Patients
Actual Study Start Date : October 25, 2017
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Entecavir

Arm Intervention/treatment
Experimental: combiantion therapy group
thymosin alpha 1 (1.6 mg subcutaneously injection twice a week) plus ETV (0.5 mg orally, daily) for 24 weeks, and followed by continuous ETV for at least 48 weeks
Drug: Thymosin Alpha1
Thymosin Alpha1 (1.6 mg subcutaneously injection twice a week) plus ETV (0.5 mg orally, daily) for 24 weeks, and followed by continuous ETV for at least 48 weeks

Drug: Entecavir
ETV (0.5 mg orally, daily) for 72 weeks

Placebo Comparator: entecavir group
ETV (0.5 mg orally, daily) at least for 72 weeks
Drug: Entecavir
ETV (0.5 mg orally, daily) for 72 weeks




Primary Outcome Measures :
  1. HBeAg seroconversion rate at week 72 [ Time Frame: week 72 ]
    HBeAg seroconversion rate at week 72


Secondary Outcome Measures :
  1. HBeAg seroconversion rate at week 48 [ Time Frame: week 48 ]
    HBeAg seroconversion rate at week 48

  2. HBsAg loss at week 48 [ Time Frame: week 48 ]
    HBsAg loss at week 48

  3. HBsAg loss at week 72 [ Time Frame: week 72 ]
    HBsAg loss at week 72

  4. HBsAg seroconversion at week 72 [ Time Frame: week 72 ]
    HBsAg seroconversion at week 72

  5. HBsAg seroconversion at week 48 [ Time Frame: week 48 ]
    HBsAg seroconversion at week 48

  6. HBsAg decline during the clinical trial [ Time Frame: week 12, weeek 24, week 36, week 48 and week 72 ]
    HBsAg decline during the clinical trial

  7. ALT normalization rate at week 72 [ Time Frame: week 72 ]
    ALT normalization rate at week 72

  8. ALT normalization rate at week 48 [ Time Frame: week 48 ]
    ALT normalization rate at week 48

  9. Rate of HBV DNA <20IU/mL at week 72 [ Time Frame: week 72 ]
    Rate of HBV DNA <20IU/mL at week 72

  10. Rate of HBV DNA <20IU/mL at week 48 [ Time Frame: week 48 ]
    Rate of HBV DNA <20IU/mL at week 48



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HBsAg positive and anti-HBs negative for more than 6 months
  • Being currently treated with ETV ≥1 years
  • HBeAg positivity and HBV DNA <60IU/mL with HBsAg <1500IU/mL and HBeAg <200S/CO at screening
  • ALT ≤5*ULN and total bilirubin ≤2*ULN
  • Age ≥ 18 yrs but ≤ 55 yrs
  • Written informed consent

Exclusion Criteria:

  • Patients who have contraindications for Thymosin alpha 1 in accordance with the approved summary of product characteristics
  • Patients with ALT > 5 x ULN or total bilirubin >2*ULN
  • Patients with evidence of hepatocellular carcinoma at screening
  • Patients with Child-Pugh score ≥7 or had a history of hepatic encephalopathy or esophageal pile or ascites
  • Patients with serological evidence of co-infection with hepatitis A virus, hepatitis C, human immunodeficiency virus or hepatitis D virus
  • Patients with a history of excessive drinking: male >40g/d,female >40g/d
  • Pregnant or breast-feeding women
  • A history of liver transplantation or planned for liver transplantation
  • Patients of autoimmune disease
  • Patients with other diseases combined
  • Patients with creatinine >1.5*ULN
  • Investigator considered not proper for participating the trial
  • Patients with other maliginant tumor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03448744


Contacts
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Contact: Yiqi Yu, MD +86-21-52888123 yyq19890619@126.com
Contact: Ying Yue, MD +86-21-52888123 ye_zicissy@sohu.com

Locations
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China, Shanghai
Huashan Hospital of Fudan University Recruiting
Shanghai, Shanghai, China, 200040
Contact: Wenhong Zhang, PhD,MD    +86 21 52889999 ext 8123    zhangwenhong@fudan.edu.cn   
Sponsors and Collaborators
Wen-hong Zhang
Investigators
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Principal Investigator: Wenhong Zhang, Ph.D Department of Infectious Diseases, Huashan Hospital
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Responsible Party: Wen-hong Zhang, Professor, Huashan Hospital
ClinicalTrials.gov Identifier: NCT03448744    
Other Study ID Numbers: KY2016-219
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wen-hong Zhang, Huashan Hospital:
thymosin alpha
entecavir
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis B, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis, Chronic
Entecavir
Thymalfasin
Antiviral Agents
Anti-Infective Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs