Trial record 111 of 367 for:    hepatitis b | Open Studies

Study to Evaluate the Non-inferiority of Cavir in HBeAg(+)Chronic Hepatitis B Patients Treated With Baraclude

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Hanmi Pharmaceutical Company Limited
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT02523547
First received: July 26, 2015
Last updated: August 13, 2015
Last verified: August 2015
  Purpose
Open-labeled, Prospective, Randomized, Multi-center, Interventional, Phase IV study.

Condition Intervention Phase
Chronic Hepatitis B
Drug: Cavir
Drug: Baraclude
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PhaseIVstudy to Evaluate the Non-inferiority of Cavir®Tab. in Terms of Hepatitis B Virus(HBV)DNA Undetectability Comparing Baraclude® Tab. in Hepatitis B e Antigen(HBeAg)(+) Chronic Hepatitis B Patients Treated With Long-term Baraclude® Tab

Resource links provided by NLM:


Further study details as provided by Hanmi Pharmaceutical Company Limited:

Primary Outcome Measures:
  • The proportion of patients with maintenance of HBV DNA undetectability [ Time Frame: 48weeks ]
    analysis


Secondary Outcome Measures:
  • The proportion of patients with HBeAg seroconversion [ Time Frame: at week 12, 24, 36 and 48 of treatment ]
    analysis

  • The proportion of patients with HBeAg seroclearance [ Time Frame: at week 12, 24, 36 and 48 of treatment ]
    analysis

  • The proportion with HBsAg seroclearance [ Time Frame: at week 48 of treatment ]
    analysis

  • The proportion with HBeAg seroconversion and HBsAb positive [ Time Frame: at week 48 of treatment ]
    analysis

  • Changes in serum HBV DNA levels [ Time Frame: at week 48 of treatment ]
    analysis

  • Changes in HBsAg titer [ Time Frame: at week 48 of treatment ]
    analysis

  • Changes in ALanine amino Transferase (ALT) [ Time Frame: at week 48 of treatment ]
    analysis

  • Proportion of patients with virologic breakthrough [ Time Frame: at week 48 of treatment ]
    virologic breakthrough is defined as the increase in serum HBV DNA (>60IU/ml) as determined by at least 2 consecutive measurements of at least 3 month apart, during continued treatment

  • Changes in EuroQoL Five Dimensions Questionnaire-3L(EQ-5D-3L) [ Time Frame: at week 48 of treatment ]
    questionnaire


Estimated Enrollment: 134
Study Start Date: January 2015
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cavir
entecavir/0.5mg/day
Drug: Cavir
0.5mg/day
Other Name: entecavir
Active Comparator: Baraclude
entecavir/0.5mg/day
Drug: Baraclude
0.5mg/day
Other Name: entecavir

Detailed Description:
The purpose of this study is to evaluate the non-inferiority and safety in terms of HBV DNA undetectability comparing Baraclude Tab. in HBeAg(+) chronic hepatitis B patients treated with long-term Baraclude Tab.
  Eligibility

Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients (over the19 years of age) currently taking Baraclude® monotherapy for chronic HBV infection for at least 24 month with < HBV DNA 60 IU/mL level, HBeAg positive and HBeAb negative status at screening.

Exclusion Criteria:

  • Patients are diagnosed Hepatitis cancer and hepatocellular carcinoma (HCC)
  • Patient has concomitant other chronic viral infection (HAV/Hepatitis C Virus (HCV)/Hepatitis D Virus(HDV)/HIV)
  • Patient had documented resistance mutations at any time before or at screening
  • Patient has clinically confirmed alcoholism, autoimmune hepatitis, malignancy with hepatic involvement, hemochromatosis, alpha-1 antitrypsin deficiency and Wilson's Disease.
  • Patient has received antiviral agent including interferon other than Baraclude within 24 months before screening for this study.
  • Patient has received immunosuppressive agent within 24 weeks before screening or corticosteroids for 4 weeks.
  • Clinical signs as indicated by any one of the following: Ccr(Cockroft-Gault) < 50ml/min, Total bilirubin > 3.0 mg/dl, Albumin < 2.7 g/dl, Prothrombin time > INR 2.3
  • Patient is pregnant or breastfeeding or willing to be pregnant
  • Patient has malignancy except for thyroid cancer and Borderline malignancy.a history of treated malignancy is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding five years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02523547

Contacts
Contact: Hanmi Pharmaceutical
Contact: EunSol Kim +82-2-410-8747 snow-white@hanmi.co.kr

Locations
Korea, Republic of
15 Sites Recruiting
Seoul, Korea, Republic of
Contact: MoonHwa Park, MD    8224109190    moonwha.park@hanmi.co.kr   
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
  More Information

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT02523547     History of Changes
Other Study ID Numbers: HM-CAV-401 
Study First Received: July 26, 2015
Last Updated: August 13, 2015

Keywords provided by Hanmi Pharmaceutical Company Limited:
entecavir

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Entecavir
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on January 23, 2017